Very Intense Radiotherapy-Chemotherapy Regimen in Advanced HNSCC

Study Overview
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Brief Summary
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Altered fractionated radiotherapy and concomitant radio-chemotherapy have been shown to be two possibilities for improving efficacy of radiotherapy in locally advanced head and neck carcinomas. In this multicentric study, we tested the hypothesis that accelerated radiotherapy could be delivered concomitantly with conventional high doses of CDDP-5FU, aiming to improve both local control and on distant metastases as compared to very accelerated radiotherapy.

Detailed Description
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Patients with a palpable N2b-c or N3 HNSCC strictly unresectable were randomized to receive either accelerated RT-CT delivering to the primary tumor 62-64 Gy / 5 weeks in 31-32 fractions of 2 Gy BID or very accelerated RT delivering 62-64 Gy in 31-32 fractions of 2 Gy BID and 22-23 days. In the accelerated RT-CT arm, 3 cycles of CDDP 100 mg/m2 were delivered at day 1, 16, 32 and 2 cycles of 5 Fu 1000 mg/m2 day 1 to 5 and 31 to 35. One month after completion of the concomitant RT-CT, 2 additional cycles of CDDP-5FU were given in patients responding (> 50%) to the initial course of RT-CT. The end points were event free survival and survival.

Official Title
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A Randomized Trial Evaluating a Very Intense Radiotherapy-Chemotherapy Regimen Versus a Very Accelerated Radiotherapy in Advanced Head and Neck Squamous Cell Carcinoma

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

Intervention / Treatment
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* Procedure: Radiotherapy 62-64 Gy in 5 W (31-32 f. of 2 Gy BID)
* Procedure: Radiotherapy 62-64 Gy in 22-23 D (31-32 f of 2 Gy BID)
* Drug: CDDP, 5 Fu


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: palpable N2b-c or N3 (UICC 1997) squamous cell carcinoma of the head and neck (oropharynx, oral cavity, hypopharynx or larynx) primary tumor and / or nodal extension strictly inoperable due to the extension of the disease performance status of 0 to 2 (WHO scoring system) renal/liver/cardiac functions and blood counts compatible with the use of CDDP and 5-FU signed inform consent Exclusion Criteria: distant metastasis previous history of cancer previous radiotherapy or chemotherapy

Ages Eligible for Study
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Minimum Age: 40 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

| Intervention/Treatment |
| --- |
|Procedure: Radiotherapy 62-64 Gy in 5 W (31-32 f. of 2 Gy BID)|nan|
|Procedure: Radiotherapy 62-64 Gy in 22-23 D (31-32 f of 2 Gy BID)|nan|
|Drug: CDDP, 5 Fu|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event free survival (event = progressive disease or relapse or or death from any cause) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  |  | 
| Toxicity |  |  | 

 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