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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Groupe Oncologie Radiotherapie Tete et Cou
Sponsor:
Information provided by (Responsible Party):
Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov Identifier:
NCT00158678
First received: September 9, 2005
Last updated: January 2, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Oral Cancer
Oropharynx Cancer
Hypopharynx Cancer
Procedure: IMRT 75 Gy
Procedure: Conventional radiotherapy 70 Gy
Drug: concomitant cisplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Groupe Oncologie Radiotherapie Tete et Cou:

Primary Outcome Measures:
  • Loco regional control [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Xerostomia at 2 years (evaluated by parotid gland scintigraphy) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Quality of life (EORTC-QLQ-H&N35) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 310
Study Start Date: September 2005
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Conventional RT 70Gy + concomitant cisplatin
Procedure: Conventional radiotherapy 70 Gy
50 Gy in PTV1 and 20 Gy in PTV2
Drug: concomitant cisplatin
100 mg/m2 D1, D22, D43
Experimental: 2
IMRT 75Gy + concomitant cisplatin
Procedure: IMRT 75 Gy
50 Gy in PTV1 and 25 Gy in 10 fractions in PTV2
Drug: concomitant cisplatin
100 mg/m2 D1, D22, D43

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158678

Contacts
Contact: Jean Bourhis, PhD bourhis@igr.fr
Contact: Michel Lapeyre, MD lapeyre@nancy.fnclcc.fr

Locations
France
Centre Alexis Vautrin Recruiting
Vandoeuvre les Nancy, France, 54511
Contact: Michel Lapeyre       lapeyre@nancy.fnclcc.fr   
Institut Gustave Roussy Recruiting
Villejuif, France, 94800
Contact: Jean Bourhis       bourhis@igr.fr   
Sponsors and Collaborators
Groupe Oncologie Radiotherapie Tete et Cou
Investigators
Principal Investigator: Jean Bourhis, PhD Gustave Roussy, Cancer Campus, Grand Paris
Principal Investigator: Michel Lapeyre, MD Centre Alexis Vautrin
  More Information

Additional Information:
No publications provided

Responsible Party: Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov Identifier: NCT00158678     History of Changes
Other Study ID Numbers: GORTEC 2004-01
Study First Received: September 9, 2005
Last Updated: January 2, 2014
Health Authority: France: Ministry of Health

Keywords provided by Groupe Oncologie Radiotherapie Tete et Cou:
oral cancer
oropharynx cancer
hypopharynx cancer
IMRT

Additional relevant MeSH terms:
Mouth Neoplasms
Carcinoma, Squamous Cell
Lip Neoplasms
Oropharyngeal Neoplasms
Hypopharyngeal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases
Lip Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 01, 2014