Accelerated Radiotherapy and Concomitant Chemo-radiotherapy in HNSCC

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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