Phase III Randomized Comparison of Radiotherapy Fractionation in Advanced Squamous Cell Carcinoma of the Head and Neck: Twice-Daily Hyperfractionation vs Split-Course Accelerated Hyperfractionation vs Accelerated Fractionation With Concomitant Boost vs Standard Fractionation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,113
研究概览
简要总结
RATIONALE: Patient abstract not available
PURPOSE: Patient abstract not available
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS: Histologically proven squamous cell carcinoma of the head and neck, including lymphoepithelioma and anaplastic carcinoma Biopsy from the primary or regional nodes acceptable No adenocarcinomas The following stages and sites are eligible: Stage III/IV oral cavity, including: Anterior 2/3 of the tongue Buccal mucosa Floor of mouth Hard palate Gingiva Retromolar trigone Stage III/IV oropharynx, including: Tonsil and pillars Faucial arch and soft palate Posterolateral pharyngeal walls Stage II/III/IV base of the tongue and hypopharynx Stage III/IV supraglottic larynx, including: Ventricular band Arytenoid Supra- and infrahyoid epiglottis Aryepiglottic fold (tumors at glottic and subglottic sites excluded) Nonpalpable nodes detected only on CT or MRI must be at least 1.0 cm in diameter or contain necrosis to prove N+ disease No metastasis below the clavicle clinically or radiologically
- •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
排除标准
- 未提供
研究组 & 干预措施
Standard Fractionation
Standard Fractionation: 2 Gy/Fx, Q.D. 5 Days/wk, Total Dose: 70 Gy/35 Fx x 7 wks
干预措施: radiation therapy (Radiation)
Standard Fractionation
Standard Fractionation: 2 Gy/Fx, Q.D. 5 Days/wk, Total Dose: 70 Gy/35 Fx x 7 wks
干预措施: conventional surgery (Procedure)
Hyperfractionation
Hyperfractionation: 1.2 Gy/Fx, b.i.d. (> 6 hours apart, 5 days/wk) Total Dose: 81.6 Gy/68 Fx/7 weeks
干预措施: conventional surgery (Procedure)
Hyperfractionation
Hyperfractionation: 1.2 Gy/Fx, b.i.d. (> 6 hours apart, 5 days/wk) Total Dose: 81.6 Gy/68 Fx/7 weeks
干预措施: low-LET cobalt-60 gamma ray therapy (Radiation)
Standard Fractionation
Standard Fractionation: 2 Gy/Fx, Q.D. 5 Days/wk, Total Dose: 70 Gy/35 Fx x 7 wks
干预措施: low-LET photon therapy (Radiation)
Standard Fractionation
Standard Fractionation: 2 Gy/Fx, Q.D. 5 Days/wk, Total Dose: 70 Gy/35 Fx x 7 wks
干预措施: low-LET cobalt-60 gamma ray therapy (Radiation)
Standard Fractionation
Standard Fractionation: 2 Gy/Fx, Q.D. 5 Days/wk, Total Dose: 70 Gy/35 Fx x 7 wks
干预措施: low-LET electron therapy (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
干预措施: low-LET electron therapy (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
干预措施: low-LET photon therapy (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
干预措施: radiation therapy (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
干预措施: low-LET cobalt-60 gamma ray therapy (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
干预措施: low-LET electron therapy (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
干预措施: low-LET photon therapy (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
干预措施: radiation therapy (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
干预措施: conventional surgery (Procedure)
Accelerated fractionation with concomitant boost
Accelerated fractionation with concomitant boost
干预措施: conventional surgery (Procedure)
Accelerated fractionation with concomitant boost
Accelerated fractionation with concomitant boost
干预措施: low-LET cobalt-60 gamma ray therapy (Radiation)
Accelerated fractionation with concomitant boost
Accelerated fractionation with concomitant boost
干预措施: low-LET electron therapy (Radiation)
Accelerated fractionation with concomitant boost
Accelerated fractionation with concomitant boost
干预措施: low-LET photon therapy (Radiation)
Accelerated fractionation with concomitant boost
Accelerated fractionation with concomitant boost
干预措施: radiation therapy (Radiation)