Trial Outcomes & Findings for Concurrent Proton and Chemotherapy in Locally Advanced Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC) (NCT NCT00495170)

Last Updated: 2019-02-06

Results Overview

The primary objective was to improve overall survival (OS). Patients are recommended to have follow up 6 weeks after completion of concurrent chemo radiotherapy for the evaluation of acute treatment toxicities, then required every 3 months (+ 1 month) for two years, then every 6 months (+ 1 month) for three years and then annually for the rest of their lives, that is standard of care. Statistics were performed with Strata/MP 14.2 software. OS was calculated by Kaplan-Meier Methodology (K-M) from the beginning of enrollment to date of death or last follow-up. Progression-free survival (PFS) was defined from enrollment to any treatment failure or death. PFS will be evaluated by series CT of chest with contrast for every follow up except 6 weeks after the concurrent chemo radiotherapy for two years. Multivariate Cox proportional hazards modeling was used to examine predictors of OS when adjusting for each of the collected potential confounding variables.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

84 participants

Primary outcome timeframe

The Overall survival (OS): From date of registration to the last follow-up (f/u), or lost to f/u, or death up to 5 years. The progression free survival (PFS): From date of registration to the date of first documented progression or death up to 5 years.

Results posted on

2019-02-06

Participant Flow

Inoperable stage III NSCLC with KPS of 70-100, medically fit to receive concurrent and/or induction chemotherapy, weight loss ≤ 10% in the 6 months before diagnosis, provide informed consent. Patients were not enrolled in cases of prior chest radiation therapy and/or pregnancy, with prior and/or concomitant malignant neoplasms.

Participant milestones

Participant milestones
Measure	Concurrent Proton and Chemotherapy Weekly infusions of carboplatin (area under the curve of 2 units) and paclitaxel (50mg/m2) with concurrent passively scattered PBT (74-Gy relative biological effectiveness)
Overall Study STARTED	84
Overall Study COMPLETED	64
Overall Study NOT COMPLETED	20

Reasons for withdrawal

Reasons for withdrawal
Measure	Concurrent Proton and Chemotherapy Weekly infusions of carboplatin (area under the curve of 2 units) and paclitaxel (50mg/m2) with concurrent passively scattered PBT (74-Gy relative biological effectiveness)
Overall Study Lost to Follow-up	9
Overall Study Withdrawal by Subject	3
Overall Study Inappropriate staging	8

Baseline Characteristics

There were 64 out of 84 patients treated under the protocol and evaluable for data analysis.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Concurrent Proton and Chemotherapy n=64 Participants Weekly infusions of carboplatin (area under the curve of 2 units) and paclitaxel (50mg/m2) with concurrent passively scattered PBT (74-Gy relative biological effectiveness)
Age, Categorical <=18 years	0 Participants n=64 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=64 Participants
Age, Categorical >=65 years	44 Participants n=64 Participants
Age, Continuous	70 years n=64 Participants
Sex: Female, Male Female	22 Participants n=64 Participants
Sex: Female, Male Male	42 Participants n=64 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=64 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	60 Participants n=64 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=64 Participants
Region of Enrollment United States	63 Participants n=64 Participants • There were 64 out of 84 patients treated under the protocol and evaluable for data analysis.
Region of Enrollment Bahamas	1 Participants n=1 Participants • There were 64 out of 84 patients treated under the protocol and evaluable for data analysis.
Non-small cell lung cancer (NSCLC) histological Subtype Squamous cell carcinoma	28 Participants n=64 Participants
Non-small cell lung cancer (NSCLC) histological Subtype Adenocarcinoma	25 Participants n=64 Participants
Non-small cell lung cancer (NSCLC) histological Subtype Non-small cell lung cancer, not otherwise specific	11 Participants n=64 Participants
Patients with Stage III Non-Small Cell Lung Cancer Gross tumor volume	87 cm^3 n=64 Participants
Patients with Stage III Non-Small Cell Lung Cancer Karnofsky performance status at diagnosis	90 units on a scale n=64 Participants • The Karnofsky Performance Score (KPS) ranking runs from 100 to 0, where 100 is "perfect" Normal health and 0 is death. Practitioners occasionally assign performance scores in between standard intervals of 10. The KPS was to allow physicians to evaluate a patient's survival. The higher KPS scores, the better treatment outcome.
American Joint Committee on Cancer (AJCC) disease staging Stage IIIA	30 Participants n=64 Participants
American Joint Committee on Cancer (AJCC) disease staging Stage IIIB	34 Participants n=64 Participants
American Joint Committee on Cancer (AJCC) TNM Categories - Primary Tumor T0-2	37 Participants n=64 Participants
American Joint Committee on Cancer (AJCC) TNM Categories - Primary Tumor T3-4	27 Participants n=64 Participants
American Joint Committee on Cancer (AJCC) TNM Categories - Lymph Nodes N0-1	6 Participants n=64 Participants
American Joint Committee on Cancer (AJCC) TNM Categories - Lymph Nodes N2-3	58 Participants n=64 Participants
Patients with Stage III Non-Small Cell Lung Cancer Chemotherapy Types Induction	20 Participants n=64 Participants • Patients will receive the weekly carboplatin and paclitaxel concurrent chemotherapy. Additional "consolidation" or adjuvant chemotherapy may be given \>/= 4 weeks after concurrent chemo/RT at the discretion of the treating medical oncologist based upon the patient's performance status and recovery from toxicities of the concurrent chemo/RT.
Patients with Stage III Non-Small Cell Lung Cancer Chemotherapy Types Concurrent	64 Participants n=64 Participants • Patients will receive the weekly carboplatin and paclitaxel concurrent chemotherapy. Additional "consolidation" or adjuvant chemotherapy may be given \>/= 4 weeks after concurrent chemo/RT at the discretion of the treating medical oncologist based upon the patient's performance status and recovery from toxicities of the concurrent chemo/RT.
Patients with Stage III Non-Small Cell Lung Cancer Chemotherapy Types Adjuvant	18 Participants n=64 Participants • Patients will receive the weekly carboplatin and paclitaxel concurrent chemotherapy. Additional "consolidation" or adjuvant chemotherapy may be given \>/= 4 weeks after concurrent chemo/RT at the discretion of the treating medical oncologist based upon the patient's performance status and recovery from toxicities of the concurrent chemo/RT.
Patients with Stage III Non-Small Cell Lung Chemotherapy Cycles Chemotherapy Induction Cycle	2 cycles n=64 Participants
Patients with Stage III Non-Small Cell Lung Chemotherapy Cycles Chemotherapy Concurrent Cycle	7 cycles n=64 Participants
Patients with Stage III Non-Small Cell Lung Chemotherapy Cycles Chemotherapy Adjuvant Cycle	8 cycles n=64 Participants

PRIMARY outcome

Timeframe: The Overall survival (OS): From date of registration to the last follow-up (f/u), or lost to f/u, or death up to 5 years. The progression free survival (PFS): From date of registration to the date of first documented progression or death up to 5 years.

Population: Kaplan-Meier analysis of overall survival (OS), progression-free survival (PFS), actuarial distant metastasis, and local regional recurrence. Patterns of treatment failure were categorized as local/regional or distant. Acute and late toxic effects were prospectively assigned using Common Terminology Criteria for Adverse Events, v3.0.

Outcome measures

Outcome measures
Measure	Concurrent Proton and Chemotherapy n=64 Participants Weekly infusions of carboplatin (area under the curve of 2 units) and paclitaxel (50mg/m2) with concurrent passively scattered PBT (74-Gy relative biological effectiveness)
Overall Survival and Progression Free Survival Progression Free Survival at 5 years	22 percentage of participants
Overall Survival and Progression Free Survival Overall Survival at 5 years	29 percentage of participants
Overall Survival and Progression Free Survival Progression Free Survival (PFS)	12.9 percentage of participants

Adverse Events

Concurrent Proton and Chemotherapy

Serious events: 35 serious events

Other events: 0 other events

Deaths: 47 deaths

Serious adverse events

Serious adverse events
Measure	Concurrent Proton and Chemotherapy n=64 participants at risk Weekly infusions of carboplatin (area under the curve of 2 units) and paclitaxel (50mg/m2) with concurrent passively scattered PBT (74-Gy relative biological effectiveness)
Respiratory, thoracic and mediastinal disorders Lobar atelectasis	0.00% 0/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Respiratory, thoracic and mediastinal disorders Cough	3.1% 2/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Respiratory, thoracic and mediastinal disorders Dyspnea	10.9% 7/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Respiratory, thoracic and mediastinal disorders Hemoptysis	0.00% 0/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Respiratory, thoracic and mediastinal disorders Hoarseness	0.00% 0/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.1% 2/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Respiratory, thoracic and mediastinal disorders Pneumonitis	12.5% 8/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Gastrointestinal disorders Constipation	0.00% 0/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Gastrointestinal disorders Diarrhea	0.00% 0/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Gastrointestinal disorders Dyspepsia	0.00% 0/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Gastrointestinal disorders Dysphagia	0.00% 0/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Gastrointestinal disorders Esophagitis	10.9% 7/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Gastrointestinal disorders Esophageal stricture	1.6% 1/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Gastrointestinal disorders Gastritis	0.00% 0/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Gastrointestinal disorders Nausea	1.6% 1/64 • Number of events 11 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Gastrointestinal disorders Odynophagia	0.00% 0/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Gastrointestinal disorders Vomiting	0.00% 0/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Cardiac disorders Arrhythmia	0.00% 0/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Cardiac disorders Palpitations	0.00% 0/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Cardiac disorders Tachycardia	0.00% 0/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Metabolism and nutrition disorders Uremia	0.00% 0/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Metabolism and nutrition disorders Blood urea nitrogen increase	0.00% 0/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Metabolism and nutrition disorders Elevated creatinine	0.00% 0/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Metabolism and nutrition disorders Anemia	6.2% 4/64 • Number of events 35 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Metabolism and nutrition disorders Hyponatremia	4.7% 3/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Metabolism and nutrition disorders Hypotension	1.6% 1/64 • Number of events 1 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Metabolism and nutrition disorders Leukopenia	23.4% 15/64 • Number of events 57 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Metabolism and nutrition disorders Lymphopenia	0.00% 0/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Metabolism and nutrition disorders Neutropenia	4.7% 3/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Metabolism and nutrition disorders Thrombocytopenia	0.00% 0/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
General disorders Anorexia	0.00% 0/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
General disorders Dehydration	6.2% 4/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
General disorders Dermatitis	9.4% 6/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
General disorders Dizziness	0.00% 0/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
General disorders Fatigue	10.9% 7/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
General disorders Fever	3.1% 2/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
General disorders Hyperpigmentation	0.00% 0/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
General disorders Pain	3.1% 2/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
General disorders Pruritus	1.6% 1/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
General disorders Rash	1.6% 1/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
General disorders Sourness	0.00% 0/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
General disorders Weight loss	6.2% 4/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Psychiatric disorders Anxiety	0.00% 0/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Skin and subcutaneous tissue disorders Candidiasis	1.6% 1/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Infections and infestations Infection	1.6% 1/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Social circumstances Insomnia	0.00% 0/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Musculoskeletal and connective tissue disorders Muscle weakness	0.00% 0/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Respiratory, thoracic and mediastinal disorders Lung atelectasis	0.00% 0/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Respiratory, thoracic and mediastinal disorders Dysphagia	0.00% 0/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Respiratory, thoracic and mediastinal disorders Bronchial fistula	1.6% 1/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Respiratory, thoracic and mediastinal disorders Bronchial stricture	0.00% 0/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.
Cardiac disorders Pericardial effusion	3.1% 2/64 • From the time of registration to the adverse event start date, assessed up to 5 years. During treatment, acute radiation adverse events will be evaluated weekly according to National Cancer Institute Common Toxicity Criteria version 3. Only grade ≥2 toxicity directly related to therapy will be documented. Pre-treatment symptoms is not required to be documented except it gets worse. Post-treatment: Patients are follow up 6 weeks after completion of concurrent chemoradiotherapy, then every 3 months for 2 years, every 6 months for 3 years.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Joe Chang / Professor, Radiation Oncology Department

UT MD Anderson Cancer Center

Phone: 713-563-2337

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place