Accelerated Radiotherapy and Concomitant Chemo-radiotherapy in HNSCC

Study Overview
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Brief Summary
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This is a multicentric randomized phase III trial comparing conventional radiotherapy with concomitant chemotherapy versus accelerated radiotherapy with concomitant chemotherapy versus very accelerated radiotherapy in patients with stage III-IV head and neck squamous cell carcinoma. The main end point is the event free survival.

Detailed Description
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This is a multicentric randomized phase III trial comparing conventional radiotherapy with concomitant chemotherapy (arm A) versus middle accelerated radiotherapy with concomitant chemotherapy (arm B) versus very accelerated radiotherapy alone (arm C) in patients with stage III-IV head and neck squamous cell carcinoma (HNSCC). The main end point is the event free survival. The treatments are Bras A : Conventional radiotherapy given once daily, delivering 70 Gy in 7 weeks (5 fractions of 2 Gy per week) and chemotherapy: 5FU : 600 mg/m²/d, Paraplatin : 70 mg/m²/d, D1-4 and D22-25 and D43-46 Bras B: middle accelerated radiotherapy delivering 70 Gy in 6 weeks and chemotherapy: 5FU : 600 mg/m²/d, Paraplatin : 70 mg/m²/d, D1-5 and D29-33 first part : radiotherapy given once daily delivering 40 Gy in 4 weeks and 20 fractions of 2 Gy second part : radiotherapy given twice daily with concomitant boost delivering 30 Gy in 20 fractions in 2 weeks (1,5 Gy x 2 / day) Bras C: very accelerated radiotherapy given twice daily delivering 64.8 Gy in 3.5 weeks in 36 fractions of 1.8 Gy

Official Title
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Phase III Trial Comparing Conventional RT With Concomitant CT Versus Accelerated RT With Concomitant CT Versus Very Accelerated RT Alone in Patients With Head and Neck Squamous Cell Carcinoma

Conditions
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Oral Cancer, Oropharynx Cancer, Hypopharynx Cancer, Larynx Cancer

Intervention / Treatment
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* Procedure: Conventional radiotherapy 70 Gy in 7 weeks
* Procedure: middle accelerated radiotherapy 70 Gy in 6 weeks
* Procedure: very accelerated radiotherapy 64.8 Gy in 3.5 weeks
* Drug: 5FU, Paraplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Squamous cell carcinoma of oral cavity, oropharynx, hypopharynx or larynx Stage III-IV (UICC 1997): T2, T3 or T4 with N0-N3 or T0 with N2-N3 Not resectable Karnofsky PS >= 70 Renal/liver/cardiac functions and blood counts compatible with the use of paraplatin and 5-FU Informed consent signed Exclusion Criteria: Distant metastasis Contra-indication to concomitant chemotherapy History of cancer History of head and neck radiotherapy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Procedure: Conventional radiotherapy 70 Gy in 7 weeks<br>* 2 gy per fraction, 1 fraction per day, 5 fractions per week<br>Drug: 5FU, Paraplatin<br>* 5FU 600mg/m²/D, Paraplatin 70mg/m²/D In arm 1: D1-4, 3 cycles during Rth (D1, D22, D43) In arm 2: D1-5, 2 cycles during Rth (D1, D29)<br>|
| Experimental: 2<br> | Procedure: middle accelerated radiotherapy 70 Gy in 6 weeks<br>* 5 x 2gy/week until 40 Gy in 20 fractions and 4 weeks, then 2 fractions of 1.5Gy per day for 30 additional Gy in 2 weeks<br>Drug: 5FU, Paraplatin<br>* 5FU 600mg/m²/D, Paraplatin 70mg/m²/D In arm 1: D1-4, 3 cycles during Rth (D1, D22, D43) In arm 2: D1-5, 2 cycles during Rth (D1, D29)<br>|
| Experimental: 3<br> | Procedure: very accelerated radiotherapy 64.8 Gy in 3.5 weeks<br>* 2 fractions of 1.8 Gy per day for 64.8 Gy in 3.5 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event free survival (event=progression, relapse, death from any cause) |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | 3 years | 
| Loco regional control |  | 3 years | 
| Toxicity |  | early and late | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Head and neck squamous cell carcinoma, Radiotherapy, Chemotherapy