Brief Title
Accelerated Radiotherapy and Concomitant Chemo-radiotherapy in HNSCC
Official Title
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
Brief Summary
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
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
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Event free survival (event=progression, relapse, death from any cause)
Secondary Outcome
Survival
Condition
Oral Cancer
Intervention
Conventional radiotherapy 70 Gy in 7 weeks
Study Arms / Comparison Groups
1
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
840
Start Date
March 2000
Completion Date
March 2011
Primary Completion Date
March 2011
Eligibility Criteria
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
Gender
All
Ages
20 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Jean Bourhis, PhD, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT00158652
Organization ID
GORTEC 99-02
Responsible Party
Sponsor
Study Sponsor
Groupe Oncologie Radiotherapie Tete et Cou
Study Sponsor
Jean Bourhis, PhD, Principal Investigator, Gustave Roussy, Cancer Campus, Grand Paris
Verification Date
November 2011