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

NCT ID: NCT00771641

Last Updated: 2014-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1113 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2013-11-30

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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Fractionation

Standard Fractionation: 2 Gy/Fx, Q.D. 5 Days/wk, Total Dose: 70 Gy/35 Fx x 7 wks

Group Type: ACTIVE_COMPARATOR

conventional surgery

Intervention Type: PROCEDURE

low-LET cobalt-60 gamma ray therapy

Intervention Type: RADIATION

low-LET electron therapy

Intervention Type: RADIATION

low-LET photon therapy

Intervention Type: RADIATION

radiation therapy

Intervention Type: RADIATION

Hyperfractionation

Hyperfractionation: 1.2 Gy/Fx, b.i.d. (\> 6 hours apart, 5 days/wk) Total Dose: 81.6 Gy/68 Fx/7 weeks

Group Type: EXPERIMENTAL

conventional surgery

Intervention Type: PROCEDURE

low-LET cobalt-60 gamma ray therapy

Intervention Type: RADIATION

low-LET electron therapy

Intervention Type: RADIATION

low-LET photon therapy

Intervention Type: RADIATION

radiation therapy

Intervention Type: RADIATION

Accelerated Hyperfractionation with split

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

Group Type: EXPERIMENTAL

conventional surgery

Intervention Type: PROCEDURE

low-LET cobalt-60 gamma ray therapy

Intervention Type: RADIATION

low-LET electron therapy

Intervention Type: RADIATION

low-LET photon therapy

Intervention Type: RADIATION

radiation therapy

Intervention Type: RADIATION

Accelerated fractionation with concomitant boost

Accelerated fractionation with concomitant boost

Group Type: EXPERIMENTAL

conventional surgery

Intervention Type: PROCEDURE

low-LET cobalt-60 gamma ray therapy

Intervention Type: RADIATION

low-LET electron therapy

Intervention Type: RADIATION

low-LET photon therapy

Intervention Type: RADIATION

radiation therapy

Intervention Type: RADIATION

Interventions

conventional surgery

Intervention Type: PROCEDURE

low-LET cobalt-60 gamma ray therapy

Intervention Type: RADIATION

low-LET electron therapy

Intervention Type: RADIATION

low-LET photon therapy

Intervention Type: RADIATION

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

PATIENT CHARACTERISTICS: Age: At least 18 Performance status: Karnofsky 60-100% Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Medically able to withstand radiotherapy No second malignancy within 5 years except nonmelanomatous skin cancer Follow-up by participating radiotherapist required

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to head and neck No planned combined external beam and interstitial boost irradiation Surgery: No prior surgery (other than biopsy) No planned combined pre- or postoperative programs Radical neck dissections allowed if lymph nodes are greater than 3 cm prior to radiotherapy or involvement persists after treatment Resection of persistent disease at the primary site may be performed 6 weeks after completion of radiotherapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Radiation Therapy Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

K. Kian Ang, MD, PhD

Role: STUDY_CHAIR

M.D. Anderson Cancer Center

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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Other Identifiers

CDR0000076475

Identifier Type: -

Identifier Source: secondary_id

RTOG-9003

Identifier Type: -

Identifier Source: org_study_id