Trial Outcomes & Findings for Optimized Intensity Modulated Irradiation for Head and Neck Cancer (NCT NCT00580983)

Last Updated: 2016-09-07

Results Overview

To objectively assess dysphagia and aspiration in patients receiving dysphagia/aspiration-sparing IMRT concurrent with chemotherapy, the percentage of participants with observer-rated dysphagia was calculated.

Recruitment status

COMPLETED

Study phase

Target enrollment

90 participants

Primary outcome timeframe

12 months

Results posted on

2016-09-07

Participant Flow

90 participants were enrolled however only 80 started treatment. Only 73 participants completed treatment. 7 did not complete the 12 month post radiation therapy (RT)swallowing studies.

Participant milestones

Participant milestones
Measure	Chemo-IMRT Chemotherapy: Chemotherapy will consist of Paclitaxel 30mg/m² IV over 1 hour, followed by Carboplatin (AUC 1) IV over 30 minutes, or Carboplatin 100mg/m² per IV over 30 minutes or Cisplatin 100mg/m² per IV over 1 hour, or Cisplatin (80mg/m²) or Carboplatin (AUC 5) IV on day 1 and 5-Fluorouracil (1000mg/m²) as a 24-hour continuous infusion, daily x 4 days. Intensity-modulated Radiation Therapy (IMRT): Primary RT: 70 Gy to gross disease and 56-63 Gy to subclinical disease in 35 fractions. Post-operative RT: 64 Gy to high-risk targets (postoperative tumor bed, first-echelon nodes) and 57.6 Gy to low-risk targets, in 32 fractions.
Overall Study STARTED	80
Overall Study COMPLETED	73
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Chemo-IMRT Chemotherapy: Chemotherapy will consist of Paclitaxel 30mg/m² IV over 1 hour, followed by Carboplatin (AUC 1) IV over 30 minutes, or Carboplatin 100mg/m² per IV over 30 minutes or Cisplatin 100mg/m² per IV over 1 hour, or Cisplatin (80mg/m²) or Carboplatin (AUC 5) IV on day 1 and 5-Fluorouracil (1000mg/m²) as a 24-hour continuous infusion, daily x 4 days. Intensity-modulated Radiation Therapy (IMRT): Primary RT: 70 Gy to gross disease and 56-63 Gy to subclinical disease in 35 fractions. Post-operative RT: 64 Gy to high-risk targets (postoperative tumor bed, first-echelon nodes) and 57.6 Gy to low-risk targets, in 32 fractions.
Overall Study Did not complete 12 mon post RT studies	7

Baseline Characteristics

Optimized Intensity Modulated Irradiation for Head and Neck Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chemo-IMRT n=73 Participants Chemotherapy: Chemotherapy will consist of Paclitaxel 30mg/m² IV over 1 hour, followed by Carboplatin (AUC 1) IV over 30 minutes, or Carboplatin 100mg/m² per IV over 30 minutes or Cisplatin 100mg/m² per IV over 1 hour, or Cisplatin (80mg/m²) or Carboplatin (AUC 5) IV on day 1 and 5-Fluorouracil (1000mg/m²) as a 24-hour continuous infusion, daily x 4 days. Intensity-modulated Radiation Therapy (IMRT): Primary RT: 70 Gy to gross disease and 56-63 Gy to subclinical disease in 35 fractions. Post-operative RT: 64 Gy to high-risk targets (postoperative tumor bed, first-echelon nodes) and 57.6 Gy to low-risk targets, in 32 fractions.
Age, Continuous	55 years n=39 Participants
Sex: Female, Male Female	8 Participants n=39 Participants
Sex: Female, Male Male	65 Participants n=39 Participants
Tumor Location Tonsil	35 participants n=39 Participants
Tumor Location Base of Tongue	38 participants n=39 Participants
Gross Tumor Volume	110 mL n=39 Participants
T Stage Stage 1	9 participants n=39 Participants
T Stage Stage 2	29 participants n=39 Participants
T Stage Stage 3	17 participants n=39 Participants
T Stage Stage 4	18 participants n=39 Participants
N Stage Stage 0	6 participants n=39 Participants
N Stage Stage 1	6 participants n=39 Participants
N Stage Stage 2	55 participants n=39 Participants
N Stage Stage 3	6 participants n=39 Participants
AJCC Stage Stage III	9 participants n=39 Participants
AJCC Stage Stage IVA	58 participants n=39 Participants
AJCC Stage Stage IVB	6 participants n=39 Participants
Smoking Status Never Smoked	26 participants n=39 Participants
Smoking Status Previous Smoker	31 participants n=39 Participants
Smoking Status Current Smoker	16 participants n=39 Participants

PRIMARY outcome

Timeframe: 12 months

Population: 90 patients were enrolled. Only 80 patients were treated and 7 patients did not complete the 12 month post-Radiation Therapy (RT) swallowing studies. Therefore only 73 patients were analyzed.

Outcome measures

Outcome measures
Measure	Chemo-IMRT n=73 Participants Chemotherapy: Chemotherapy will consist of Paclitaxel 30mg/m² IV over 1 hour, followed by Carboplatin (AUC 1) IV over 30 minutes, or Carboplatin 100mg/m² per IV over 30 minutes or Cisplatin 100mg/m² per IV over 1 hour, or Cisplatin (80mg/m²) or Carboplatin (AUC 5) IV on day 1 and 5-Fluorouracil (1000mg/m²) as a 24-hour continuous infusion, daily x 4 days. Intensity-modulated Radiation Therapy (IMRT): Primary RT: 70 Gy to gross disease and 56-63 Gy to subclinical disease in 35 fractions. Post-operative RT: 64 Gy to high-risk targets (postoperative tumor bed, first-echelon nodes) and 57.6 Gy to low-risk targets, in 32 fractions.
Percentage of Participants With Grade 0-1 Observer-rated Dysphagia	94 percentage of participants

SECONDARY outcome

Timeframe: 5 years

To assess the relationships between the mean radiotherapy dose delivered and objectively measured dysphagia.

Outcome measures

Outcome measures
Measure	Chemo-IMRT n=73 Participants Chemotherapy: Chemotherapy will consist of Paclitaxel 30mg/m² IV over 1 hour, followed by Carboplatin (AUC 1) IV over 30 minutes, or Carboplatin 100mg/m² per IV over 30 minutes or Cisplatin 100mg/m² per IV over 1 hour, or Cisplatin (80mg/m²) or Carboplatin (AUC 5) IV on day 1 and 5-Fluorouracil (1000mg/m²) as a 24-hour continuous infusion, daily x 4 days. Intensity-modulated Radiation Therapy (IMRT): Primary RT: 70 Gy to gross disease and 56-63 Gy to subclinical disease in 35 fractions. Post-operative RT: 64 Gy to high-risk targets (postoperative tumor bed, first-echelon nodes) and 57.6 Gy to low-risk targets, in 32 fractions.
The Mean Esophageal Radiotherapy Dose in Patients With Strictures and Without Strictures Patients with Strictures (N=5)	48 Gray (Gy) Standard Deviation 17
The Mean Esophageal Radiotherapy Dose in Patients With Strictures and Without Strictures Patients without strictures (N=68)	27 Gray (Gy) Standard Deviation 12

Adverse Events

Chemo-IMRT

Serious events: 26 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Chemo-IMRT n=73 participants at risk Chemotherapy: Chemotherapy will consist of Paclitaxel 30mg/m² IV over 1 hour, followed by Carboplatin (AUC 1) IV over 30 minutes, or Carboplatin 100mg/m² per IV over 30 minutes or Cisplatin 100mg/m² per IV over 1 hour, or Cisplatin (80mg/m²) or Carboplatin (AUC 5) IV on day 1 and 5-Fluorouracil (1000mg/m²) as a 24-hour continuous infusion, daily x 4 days. Intensity-modulated Radiation Therapy (IMRT): Primary RT: 70 Gy to gross disease and 56-63 Gy to subclinical disease in 35 fractions. Post-operative RT: 64 Gy to high-risk targets (postoperative tumor bed, first-echelon nodes) and 57.6 Gy to low-risk targets, in 32 fractions.
Psychiatric disorders Anxiety	1.4% 1/73 90 patients were enrolled. Only 80 patients were treated and 7 patients did not complete the 12 month post-Radiation Therapy (RT) swallowing studies. Therefore only 73 patients were included in the adverse events analysis.
Gastrointestinal disorders Constipation	1.4% 1/73 90 patients were enrolled. Only 80 patients were treated and 7 patients did not complete the 12 month post-Radiation Therapy (RT) swallowing studies. Therefore only 73 patients were included in the adverse events analysis.
General disorders Death	1.4% 1/73 90 patients were enrolled. Only 80 patients were treated and 7 patients did not complete the 12 month post-Radiation Therapy (RT) swallowing studies. Therefore only 73 patients were included in the adverse events analysis.
Metabolism and nutrition disorders Dehydration	4.1% 3/73 90 patients were enrolled. Only 80 patients were treated and 7 patients did not complete the 12 month post-Radiation Therapy (RT) swallowing studies. Therefore only 73 patients were included in the adverse events analysis.
Gastrointestinal disorders Dobhoff Tube Complication	1.4% 1/73 90 patients were enrolled. Only 80 patients were treated and 7 patients did not complete the 12 month post-Radiation Therapy (RT) swallowing studies. Therefore only 73 patients were included in the adverse events analysis.
Gastrointestinal disorders Dysphagia	4.1% 3/73 90 patients were enrolled. Only 80 patients were treated and 7 patients did not complete the 12 month post-Radiation Therapy (RT) swallowing studies. Therefore only 73 patients were included in the adverse events analysis.
Gastrointestinal disorders Esophageal Stricture	1.4% 1/73 90 patients were enrolled. Only 80 patients were treated and 7 patients did not complete the 12 month post-Radiation Therapy (RT) swallowing studies. Therefore only 73 patients were included in the adverse events analysis.
General disorders Fever	2.7% 2/73 90 patients were enrolled. Only 80 patients were treated and 7 patients did not complete the 12 month post-Radiation Therapy (RT) swallowing studies. Therefore only 73 patients were included in the adverse events analysis.
Nervous system disorders Headache	1.4% 1/73 90 patients were enrolled. Only 80 patients were treated and 7 patients did not complete the 12 month post-Radiation Therapy (RT) swallowing studies. Therefore only 73 patients were included in the adverse events analysis.
Respiratory, thoracic and mediastinal disorders Hemoptysis	1.4% 1/73 90 patients were enrolled. Only 80 patients were treated and 7 patients did not complete the 12 month post-Radiation Therapy (RT) swallowing studies. Therefore only 73 patients were included in the adverse events analysis.
Investigations Hyperlipedemia	1.4% 1/73 90 patients were enrolled. Only 80 patients were treated and 7 patients did not complete the 12 month post-Radiation Therapy (RT) swallowing studies. Therefore only 73 patients were included in the adverse events analysis.
Cardiac disorders Hypertension	1.4% 1/73 90 patients were enrolled. Only 80 patients were treated and 7 patients did not complete the 12 month post-Radiation Therapy (RT) swallowing studies. Therefore only 73 patients were included in the adverse events analysis.
General disorders Increased Mucous Secretions	1.4% 1/73 90 patients were enrolled. Only 80 patients were treated and 7 patients did not complete the 12 month post-Radiation Therapy (RT) swallowing studies. Therefore only 73 patients were included in the adverse events analysis.
Skin and subcutaneous tissue disorders Induration of Skin	1.4% 1/73 90 patients were enrolled. Only 80 patients were treated and 7 patients did not complete the 12 month post-Radiation Therapy (RT) swallowing studies. Therefore only 73 patients were included in the adverse events analysis.
Psychiatric disorders Mental Status Change	4.1% 3/73 90 patients were enrolled. Only 80 patients were treated and 7 patients did not complete the 12 month post-Radiation Therapy (RT) swallowing studies. Therefore only 73 patients were included in the adverse events analysis.
Gastrointestinal disorders Mucositis	5.5% 4/73 90 patients were enrolled. Only 80 patients were treated and 7 patients did not complete the 12 month post-Radiation Therapy (RT) swallowing studies. Therefore only 73 patients were included in the adverse events analysis.
Gastrointestinal disorders Nausea	9.6% 7/73 90 patients were enrolled. Only 80 patients were treated and 7 patients did not complete the 12 month post-Radiation Therapy (RT) swallowing studies. Therefore only 73 patients were included in the adverse events analysis.
General disorders Neck Pain	2.7% 2/73 90 patients were enrolled. Only 80 patients were treated and 7 patients did not complete the 12 month post-Radiation Therapy (RT) swallowing studies. Therefore only 73 patients were included in the adverse events analysis.
General disorders Neck Swelling	1.4% 1/73 90 patients were enrolled. Only 80 patients were treated and 7 patients did not complete the 12 month post-Radiation Therapy (RT) swallowing studies. Therefore only 73 patients were included in the adverse events analysis.
Gastrointestinal disorders Odynophagia	1.4% 1/73 90 patients were enrolled. Only 80 patients were treated and 7 patients did not complete the 12 month post-Radiation Therapy (RT) swallowing studies. Therefore only 73 patients were included in the adverse events analysis.
Surgical and medical procedures PEG Tube Complications	1.4% 1/73 90 patients were enrolled. Only 80 patients were treated and 7 patients did not complete the 12 month post-Radiation Therapy (RT) swallowing studies. Therefore only 73 patients were included in the adverse events analysis.
Gastrointestinal disorders Pharyngeal Stenosis	1.4% 1/73 90 patients were enrolled. Only 80 patients were treated and 7 patients did not complete the 12 month post-Radiation Therapy (RT) swallowing studies. Therefore only 73 patients were included in the adverse events analysis.
Infections and infestations Pneumonia	9.6% 7/73 90 patients were enrolled. Only 80 patients were treated and 7 patients did not complete the 12 month post-Radiation Therapy (RT) swallowing studies. Therefore only 73 patients were included in the adverse events analysis.
Metabolism and nutrition disorders Poor Oral Intake	1.4% 1/73 90 patients were enrolled. Only 80 patients were treated and 7 patients did not complete the 12 month post-Radiation Therapy (RT) swallowing studies. Therefore only 73 patients were included in the adverse events analysis.
Skin and subcutaneous tissue disorders Skin Redness	1.4% 1/73 90 patients were enrolled. Only 80 patients were treated and 7 patients did not complete the 12 month post-Radiation Therapy (RT) swallowing studies. Therefore only 73 patients were included in the adverse events analysis.
Gastrointestinal disorders Stomatitis	1.4% 1/73 90 patients were enrolled. Only 80 patients were treated and 7 patients did not complete the 12 month post-Radiation Therapy (RT) swallowing studies. Therefore only 73 patients were included in the adverse events analysis.
Nervous system disorders Syncope	1.4% 1/73 90 patients were enrolled. Only 80 patients were treated and 7 patients did not complete the 12 month post-Radiation Therapy (RT) swallowing studies. Therefore only 73 patients were included in the adverse events analysis.
Gastrointestinal disorders Thrush	2.7% 2/73 90 patients were enrolled. Only 80 patients were treated and 7 patients did not complete the 12 month post-Radiation Therapy (RT) swallowing studies. Therefore only 73 patients were included in the adverse events analysis.
Gastrointestinal disorders Ulceration of the Mucous Membrane	1.4% 1/73 90 patients were enrolled. Only 80 patients were treated and 7 patients did not complete the 12 month post-Radiation Therapy (RT) swallowing studies. Therefore only 73 patients were included in the adverse events analysis.
Renal and urinary disorders Urinary Tract Infection	1.4% 1/73 90 patients were enrolled. Only 80 patients were treated and 7 patients did not complete the 12 month post-Radiation Therapy (RT) swallowing studies. Therefore only 73 patients were included in the adverse events analysis.
Gastrointestinal disorders Vomiting	9.6% 7/73 90 patients were enrolled. Only 80 patients were treated and 7 patients did not complete the 12 month post-Radiation Therapy (RT) swallowing studies. Therefore only 73 patients were included in the adverse events analysis.
General disorders Weight Loss	1.4% 1/73 90 patients were enrolled. Only 80 patients were treated and 7 patients did not complete the 12 month post-Radiation Therapy (RT) swallowing studies. Therefore only 73 patients were included in the adverse events analysis.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Avraham Eisbruch, M.D.

University of Michigan Comprehensive Cancer Center

Phone: 734-936-4302

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place