IMRT Plus Cisplatin Versus Conventional Radiotherapy Plus Cisplatin in Stage III-IV HNSCC

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Brief Title

IMRT Plus Cisplatin Versus Conventional Radiotherapy Plus Cisplatin in Stage III-IV HNSCC

Official Title

Phase III Trial of Intensity-modulated Radiotherapy Plus Cisplatin Versus Conventional Radiotherapy Plus Cisplatin in Patients With Stage III-IV Head and Neck Squamous Cell Carcinoma

Brief Summary

      This is a multicentric randomized phase III trial comparing intensity-modulated radiotherapy
      (75 Gy) plus cisplatin versus conventional radiotherapy (70 Gy) plus cisplatin in patients
      with stage III-IV squamous cell carcinoma of oral cavity, oropharynx or hypopharynx. The main
      end points are the rate of locoregional control and the rate of xerostomia at 2 years.

Detailed Description

      This is a multicentric randomized phase III trial comparing intensity-modulated radiotherapy
      plus concomitant cisplatin versus conventional radiotherapy plus concomitant cisplatin in
      patients with stage III-IV squamous cell carcinoma of oral cavity, oropharynx or hypopharynx.
      The main end points are the rate of locoregional control and the rate of xerostomia at 2
      years.

      The IMRT total dose is 75 Gy (50 Gy to PTV1 and T0 + 25 Gy (10 fractions) to PTV2). The
      conventional radiotherapy total dose is 70 Gy (50 Gy to PTV1 + 20 Gy (10 fractions) to PTV2).
      In both arms, the cervical nodes will receive 50 Gy (65 Gy in case of Np) by conventional
      radiotherapy (IMRT is allowed in the IRMT arm). In the two arms, patients will receive
      concomitant cisplatin (100 mg/m² D1, D21, D42).

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Loco regional control

Secondary Outcome

 Survival

Condition

Oral Cancer

Intervention

IMRT 75 Gy

Study Arms / Comparison Groups

 1
Description:  Conventional RT 70Gy + concomitant cisplatin

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

310

Start Date

September 27, 2005

Completion Date

March 22, 2020

Primary Completion Date

March 22, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  squamous cell carcinoma of oral cavity, oropharynx or hypopharynx

          -  Stage III - IV (T1-T4, N0-N2)(UICC 2002)

          -  Not resected

          -  Indication of radiotherapy to bilateral cervical nodes at dose>= 50 Gy

          -  Delineation of target volumes done before randomization

          -  Scintigraphy of parotid gland done before radiotherapy start

          -  Quality of life questionnaires (EORTC-C30 and EORTC-H&N35) filled in by the patient

          -  Informed consent signed

        Exclusion Criteria:

          -  N3 (UICC 2002)

          -  Distant metastasis

          -  Contra-indication to concomitant cisplatin

          -  History of cancer within the last 5 years

          -  History of head and neck radiotherapy

          -  Administration of drugs for treatment or prophylaxis of xerostomia (pilocarpine,
             ethyol)

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jean Bourhis, PhD, ,

Location Countries

France

Location Countries

France

Administrative Informations

NCT ID

NCT00158678

Organization ID

GORTEC 2004-01

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

April 2020