Fractionated Radiation Therapy in Treating Advanced Squamous Cell Carcinoma of the Head and Neck

Phase 3

Completed

• Conditions: Head and Neck Cancer
• Interventions: Procedure: conventional surgery; Radiation: low-LET cobalt-60 gamma ray therapy; Radiation: low-LET electron therapy; Radiation: low-LET photon therapy; Radiation: radiation therapy

• Registration Number: NCT00771641
• Lead Sponsor: Radiation Therapy Oncology Group

Brief Summary

RATIONALE: Patient abstract not available

PURPOSE: Patient abstract not available

Detailed Description

OBJECTIVES: I. Determine whether hyperfractionation and/or accelerated fractionation (split-course or with a concomitant boost) improves the locoregional control rate over standard fractionation radiotherapy in patients with advanced squamous cell carcinomas of the head and neck. II. Determine the disease-free survival and overall survival of these patients treated with different radiotherapy fractionation schemes. III. Determine the acute and late toxicities of each fractionation schedule. IV. Compare the quality of life on the two regimens.

OUTLINE: Randomized study. Arm I: Radiotherapy. Irradiation of primary tumor and involved and at-risk nodal areas using linear accelerators with photon energies of 1.25-6.0 MV (dual energy arrangements may also use a beam greater than 6.0 MV), electrons of 4-25 MV, or Co60. Standard fractionation. Arm II: Radiotherapy. Targets and equipment as in Arm I. Hyperfractionation. Arm III: Radiotherapy. Targets and equipment as in Arm I. Accelerated split-course hyperfractionation. Arm IV: Radiotherapy. Targets and equipment as in Arm I. Accelerated fractionation with concomitant boost.

PROJECTED ACCRUAL: A total of 1,080 patients (270/arm) will be accrued over 5.75 years. If excessive toxicity is noted in any arm after entry of 324 and 634 patients, that arm may be closed.

Study Timeline

• Primary Completion: 2002-08
• Study First Submitted: 2008-10-10
• Study First Submitted QC: 2008-10-10
• Study First Posted: 2008-10-13
• Study Completion: 2013-11
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-23
• Last Update Posted: 2014-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1113

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Accelerated fractionation with concomitant boost	conventional surgery	Accelerated fractionation with concomitant boost
Accelerated fractionation with concomitant boost	low-LET cobalt-60 gamma ray therapy	Accelerated fractionation with concomitant boost
Hyperfractionation	low-LET cobalt-60 gamma ray therapy	Hyperfractionation: 1.2 Gy/Fx, b.i.d. (\> 6 hours apart, 5 days/wk) Total Dose: 81.6 Gy/68 Fx/7 weeks
Standard Fractionation	low-LET electron therapy	Standard Fractionation: 2 Gy/Fx, Q.D. 5 Days/wk, Total Dose: 70 Gy/35 Fx x 7 wks
Standard Fractionation	low-LET cobalt-60 gamma ray therapy	Standard Fractionation: 2 Gy/Fx, Q.D. 5 Days/wk, Total Dose: 70 Gy/35 Fx x 7 wks
Hyperfractionation	conventional surgery	Hyperfractionation: 1.2 Gy/Fx, b.i.d. (\> 6 hours apart, 5 days/wk) Total Dose: 81.6 Gy/68 Fx/7 weeks
Hyperfractionation	low-LET electron therapy	Hyperfractionation: 1.2 Gy/Fx, b.i.d. (\> 6 hours apart, 5 days/wk) Total Dose: 81.6 Gy/68 Fx/7 weeks
Hyperfractionation	radiation therapy	Hyperfractionation: 1.2 Gy/Fx, b.i.d. (\> 6 hours apart, 5 days/wk) Total Dose: 81.6 Gy/68 Fx/7 weeks
Accelerated Hyperfractionation with split	low-LET electron therapy	Accelerated Hyperfractionation with split: 1.6 Gy/Fx b.i.d. (\> 6 hours apart), 5 days/wk, Total Dose: 67.2 Gy/42 Fx/6 wks with a 2 week rest after 38.4 Gy
Accelerated Hyperfractionation with split	radiation therapy	Accelerated Hyperfractionation with split: 1.6 Gy/Fx b.i.d. (\> 6 hours apart), 5 days/wk, Total Dose: 67.2 Gy/42 Fx/6 wks with a 2 week rest after 38.4 Gy
Standard Fractionation	radiation therapy	Standard Fractionation: 2 Gy/Fx, Q.D. 5 Days/wk, Total Dose: 70 Gy/35 Fx x 7 wks
Standard Fractionation	conventional surgery	Standard Fractionation: 2 Gy/Fx, Q.D. 5 Days/wk, Total Dose: 70 Gy/35 Fx x 7 wks
Accelerated Hyperfractionation with split	conventional surgery	Accelerated Hyperfractionation with split: 1.6 Gy/Fx b.i.d. (\> 6 hours apart), 5 days/wk, Total Dose: 67.2 Gy/42 Fx/6 wks with a 2 week rest after 38.4 Gy
Accelerated Hyperfractionation with split	low-LET cobalt-60 gamma ray therapy	Accelerated Hyperfractionation with split: 1.6 Gy/Fx b.i.d. (\> 6 hours apart), 5 days/wk, Total Dose: 67.2 Gy/42 Fx/6 wks with a 2 week rest after 38.4 Gy
Accelerated Hyperfractionation with split	low-LET photon therapy	Accelerated Hyperfractionation with split: 1.6 Gy/Fx b.i.d. (\> 6 hours apart), 5 days/wk, Total Dose: 67.2 Gy/42 Fx/6 wks with a 2 week rest after 38.4 Gy
Accelerated fractionation with concomitant boost	low-LET electron therapy	Accelerated fractionation with concomitant boost
Standard Fractionation	low-LET photon therapy	Standard Fractionation: 2 Gy/Fx, Q.D. 5 Days/wk, Total Dose: 70 Gy/35 Fx x 7 wks
Hyperfractionation	low-LET photon therapy	Hyperfractionation: 1.2 Gy/Fx, b.i.d. (\> 6 hours apart, 5 days/wk) Total Dose: 81.6 Gy/68 Fx/7 weeks
Accelerated fractionation with concomitant boost	low-LET photon therapy	Accelerated fractionation with concomitant boost
Accelerated fractionation with concomitant boost	radiation therapy	Accelerated fractionation with concomitant boost