Trial Outcomes & Findings for Locally Advanced NSCLC Hyperfractionated RT (NCT NCT03128008)
NCT ID: NCT03128008
Last Updated: 2021-05-28
Results Overview
For the cohort of the participants who meet eligibility criteria and receive radiotherapy with concurrent chemotherapy, the metabolic complete response (MCR) rate will be measured with interim PET-CT utilizing PERCIST response reporting criteria.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
4 weeks
Results posted on
2021-05-28
Participant Flow
Participant milestones
| Measure |
Carboplatin/Paclitaxel With Radiation Therapy
Eligible subjects will receive standard of care Carboplatin IV once a week, Paclitaxel IV once a week given concurrently with daily hyperfractionated radiation therapy (RT). RT will be delivered as 6 fractions weekly.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Locally Advanced NSCLC Hyperfractionated RT
Baseline characteristics by cohort
| Measure |
Carboplatin/Paclitaxel With Radiation Therapy
n=10 Participants
Single arm, non randomized, open label study. Eligible subjects will receive standard of care Carboplatin IV once a week, Paclitaxel IV once a week given concurrently with daily hyperfractionated radiation therapy (RT). RT will be delivered as 6 fractions weekly.
Carboplatin: Single arm non randomized open label study. Subjects will receive standard of care Carboplatin IV once a week. Chemotherapy is given concurrently with daily hyperfractioned radiation therapy.
Paclitaxel: Single arm non randomized open label study. Subjects will receive standard of care Paclitaxel IV once a week. Chemotherapy is given concurrently with daily hyperfractioned radiation therapy.
|
|---|---|
|
Age, Continuous
|
67.5 years
STANDARD_DEVIATION 7.18 • n=99 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: 8 participants have RECIST measurements available
For the cohort of the participants who meet eligibility criteria and receive radiotherapy with concurrent chemotherapy, the metabolic complete response (MCR) rate will be measured with interim PET-CT utilizing PERCIST response reporting criteria.
Outcome measures
| Measure |
Carboplatin/Paclitaxel With Radiation Therapy
n=8 Participants
Eligible participants will receive standard of care Carboplatin IV once a week, Paclitaxel IV once a week given concurrently with daily hyperfractionated radiation therapy (RT). RT will be delivered as 6 fractions weekly.
|
|---|---|
|
The Metabolic Complete Response Rate, Assessed Using Interim PET-CT, in an Accelerated Fashion (2 Gy/Fraction, 6 Fractions/Week) With Concurrent Chemotherapy
Progressive Disease
|
1 Participants
|
|
The Metabolic Complete Response Rate, Assessed Using Interim PET-CT, in an Accelerated Fashion (2 Gy/Fraction, 6 Fractions/Week) With Concurrent Chemotherapy
Stable Disease
|
6 Participants
|
|
The Metabolic Complete Response Rate, Assessed Using Interim PET-CT, in an Accelerated Fashion (2 Gy/Fraction, 6 Fractions/Week) With Concurrent Chemotherapy
Partial Response
|
1 Participants
|
|
The Metabolic Complete Response Rate, Assessed Using Interim PET-CT, in an Accelerated Fashion (2 Gy/Fraction, 6 Fractions/Week) With Concurrent Chemotherapy
Complete Response
|
0 Participants
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: 9 participants indicated whether they had Boost or not
In the same participant cohort, the proportion of the participants who are eligible for an RT boost after completing a standard dose of RT (60 Gy), delivered in an accelerated fashion (6 fractions/week) with concurrent chemotherapy, will be estimated as well as its confidence interval.
Outcome measures
| Measure |
Carboplatin/Paclitaxel With Radiation Therapy
n=9 Participants
Eligible participants will receive standard of care Carboplatin IV once a week, Paclitaxel IV once a week given concurrently with daily hyperfractionated radiation therapy (RT). RT will be delivered as 6 fractions weekly.
|
|---|---|
|
The Number of Participants Eligible for an RT Boost After Completing a Standard Dose of RT (60 Gy), Delivered in an Accelerated Fashion (6 Fractions/Week) With Concurrent Chemotherapy
|
3 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: 1 participant did not have any follow up data
The overall survival (OS) for the treated participants will be characterized by Kaplan-Meier estimator. The medial OS will be estimated with a 95% confidence interval.
Outcome measures
| Measure |
Carboplatin/Paclitaxel With Radiation Therapy
n=9 Participants
Eligible participants will receive standard of care Carboplatin IV once a week, Paclitaxel IV once a week given concurrently with daily hyperfractionated radiation therapy (RT). RT will be delivered as 6 fractions weekly.
|
|---|---|
|
Overall Survival With an Accelerated and Adaptive RT Approach.
|
NA months
The median survival time was not estimable due to the small sample size (2 in 9 participants were deceased). It was not possible to calculate the lower 95% confidence interval because the median survival (50% patients deceased in the cohort) was not reached.
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: One participant did not have any follow up data
Median progression-free survival for participants will be characterized by Kaplan-Meier estimator. The median PFS will be estimated as well as their 95% confidence intervals.
Outcome measures
| Measure |
Carboplatin/Paclitaxel With Radiation Therapy
n=9 Participants
Eligible participants will receive standard of care Carboplatin IV once a week, Paclitaxel IV once a week given concurrently with daily hyperfractionated radiation therapy (RT). RT will be delivered as 6 fractions weekly.
|
|---|---|
|
Progression-free Survival (PFS) With an Accelerated and Adaptive RT Approach.
|
13.39 months
Interval 2.58 to
The upper confidence level could not be measured due to the small sample size.
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: One participant does not have any follow up data.
The local control rate for the same cohort of participants will be measured by standard of care imaging per NCCN guidelines at routine follow up clinic visits.
Outcome measures
| Measure |
Carboplatin/Paclitaxel With Radiation Therapy
n=9 Participants
Eligible participants will receive standard of care Carboplatin IV once a week, Paclitaxel IV once a week given concurrently with daily hyperfractionated radiation therapy (RT). RT will be delivered as 6 fractions weekly.
|
|---|---|
|
Number of Participants With Local Control With an Accelerated and Adaptive RT Approach
|
1 Participants
|
Adverse Events
Carboplatin/Paclitaxel With Radiation Therapy
Serious events: 6 serious events
Other events: 9 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Carboplatin/Paclitaxel With Radiation Therapy
n=10 participants at risk
Single arm, non randomized, open label study. Eligible subjects will receive standard of care Carboplatin IV once a week, Paclitaxel IV once a week given concurrently with daily hyperfractionated radiation therapy (RT). RT will be delivered as 6 fractions weekly.
Carboplatin: Single arm non randomized open label study. Subjects will receive standard of care Carboplatin IV once a week. Chemotherapy is given concurrently with daily hyperfractioned radiation therapy.
Paclitaxel: Single arm non randomized open label study. Subjects will receive standard of care Paclitaxel IV once a week. Chemotherapy is given concurrently with daily hyperfractioned radiation therapy.
|
|---|---|
|
Immune system disorders
Allergic reaction
|
20.0%
2/10 • 2 years
|
|
Gastrointestinal disorders
Esophageal Ulcer
|
10.0%
1/10 • 2 years
|
|
Gastrointestinal disorders
Esophagitis
|
10.0%
1/10 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
10.0%
1/10 • 2 years
|
|
Investigations
Cardiac troponin T increased
|
10.0%
1/10 • 2 years
|
Other adverse events
| Measure |
Carboplatin/Paclitaxel With Radiation Therapy
n=10 participants at risk
Single arm, non randomized, open label study. Eligible subjects will receive standard of care Carboplatin IV once a week, Paclitaxel IV once a week given concurrently with daily hyperfractionated radiation therapy (RT). RT will be delivered as 6 fractions weekly.
Carboplatin: Single arm non randomized open label study. Subjects will receive standard of care Carboplatin IV once a week. Chemotherapy is given concurrently with daily hyperfractioned radiation therapy.
Paclitaxel: Single arm non randomized open label study. Subjects will receive standard of care Paclitaxel IV once a week. Chemotherapy is given concurrently with daily hyperfractioned radiation therapy.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
30.0%
3/10 • Number of events 7 • 2 years
|
|
Investigations
Lymphocyte count decreased
|
80.0%
8/10 • Number of events 17 • 2 years
|
|
Investigations
Neutrophil Count decreased
|
60.0%
6/10 • Number of events 9 • 2 years
|
|
Investigations
White blood cell decreased
|
70.0%
7/10 • Number of events 13 • 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
2/10 • Number of events 4 • 2 years
|
|
Investigations
Weight loss
|
80.0%
8/10 • Number of events 10 • 2 years
|
|
Cardiac disorders
Palpitations
|
20.0%
2/10 • Number of events 2 • 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
30.0%
3/10 • Number of events 4 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
40.0%
4/10 • Number of events 4 • 2 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
30.0%
3/10 • Number of events 3 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
50.0%
5/10 • Number of events 5 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
50.0%
5/10 • Number of events 9 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
30.0%
3/10 • Number of events 4 • 2 years
|
|
General disorders
Fatigue
|
90.0%
9/10 • Number of events 11 • 2 years
|
|
General disorders
Non-cardiac chest pain
|
30.0%
3/10 • Number of events 3 • 2 years
|
|
General disorders
Pain
|
30.0%
3/10 • Number of events 4 • 2 years
|
|
Infections and infestations
Mucosal infection
|
20.0%
2/10 • Number of events 2 • 2 years
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
70.0%
7/10 • Number of events 10 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
20.0%
2/10 • Number of events 2 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
40.0%
4/10 • Number of events 5 • 2 years
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
30.0%
3/10 • Number of events 3 • 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
30.0%
3/10 • Number of events 4 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
50.0%
5/10 • Number of events 6 • 2 years
|
|
Psychiatric disorders
Anxiety
|
20.0%
2/10 • Number of events 2 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
60.0%
6/10 • Number of events 7 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
30.0%
3/10 • Number of events 3 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
20.0%
2/10 • Number of events 3 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
20.0%
2/10 • Number of events 2 • 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
30.0%
3/10 • Number of events 3 • 2 years
|
|
Cardiac disorders
cardiac disorders -other specify
|
10.0%
1/10 • Number of events 1 • 2 years
|
|
Cardiac disorders
chest pain, cardiac
|
10.0%
1/10 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
esophageal ulcer
|
10.0%
1/10 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
esophagitis
|
80.0%
8/10 • Number of events 9 • 2 years
|
|
General disorders
Fever
|
10.0%
1/10 • Number of events 1 • 2 years
|
|
Immune system disorders
Allergic reaction
|
50.0%
5/10 • Number of events 5 • 2 years
|
|
Infections and infestations
Papulopustular rash
|
10.0%
1/10 • Number of events 1 • 2 years
|
|
Infections and infestations
Upper respiratory infection
|
10.0%
1/10 • Number of events 1 • 2 years
|
|
Investigations
alanine aminotransferase increased
|
30.0%
3/10 • Number of events 3 • 2 years
|
|
Investigations
alkaline phosphatase increased
|
10.0%
1/10 • Number of events 2 • 2 years
|
|
Investigations
lymphocyte count increased
|
10.0%
1/10 • Number of events 1 • 2 years
|
|
Investigations
platelet count decreased
|
10.0%
1/10 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
hyperkalemia
|
10.0%
1/10 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
10.0%
1/10 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.0%
1/10 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
10.0%
1/10 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
10.0%
1/10 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
10.0%
1/10 • Number of events 1 • 2 years
|
|
Nervous system disorders
Dysgeusia
|
10.0%
1/10 • Number of events 1 • 2 years
|
|
Nervous system disorders
Tremor
|
10.0%
1/10 • Number of events 1 • 2 years
|
|
Psychiatric disorders
Insomnia
|
10.0%
1/10 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
allergic rhinitis
|
10.0%
1/10 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
aspiration
|
10.0%
1/10 • Number of events 2 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
10.0%
1/10 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
10.0%
1/10 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
10.0%
1/10 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
20.0%
2/10 • Number of events 2 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
10.0%
1/10 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
10.0%
1/10 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
1/10 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
10.0%
1/10 • Number of events 1 • 2 years
|
|
Vascular disorders
hypertension
|
10.0%
1/10 • Number of events 1 • 2 years
|
|
Vascular disorders
hypotension
|
10.0%
1/10 • Number of events 1 • 2 years
|
|
Vascular disorders
Thromboembolic event
|
10.0%
1/10 • Number of events 1 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place