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

Sponsored by:	Groupe Oncologie Radiotherapie Tete et Cou
Information provided by:	Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov Identifier:	NCT00158678

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 III

MedlinePlus related topics: Cancer Oral Cancer

Drug Information available for: Cisplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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 Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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
2: Experimental 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

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
Institut Gustave Roussy	Recruiting
Villejuif, France, 94800
Contact: Jean Bourhis bourhis@igr.fr
Centre Alexis Vautrin	Recruiting
Vandoeuvre les Nancy, France, 54511
Contact: Michel Lapeyre lapeyre@nancy.fnclcc.fr
CHU Poitiers - Hôpital Jean Bernard	Not yet recruiting
Poitiers, France, 86021
Contact: Stephane Guerif s.guerif@chu-poitiers.fr

Sponsors and Collaborators

Groupe Oncologie Radiotherapie Tete et Cou

Investigators

Principal Investigator:	Jean Bourhis, PhD	Institut Gustave Roussy
Principal Investigator:	Michel Lapeyre, MD	Centre Alexis Vautrin

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	GORTEC ( Jean BOURHIS, MD, PhD )
Study ID Numbers:	GORTEC 2004-01
Study First Received:	September 9, 2005
Last Updated:	January 28, 2008
ClinicalTrials.gov Identifier:	NCT00158678
Health Authority:	France: Ministry of Health

Keywords provided by Groupe Oncologie Radiotherapie Tete et Cou:

oral cancer
oropharynx cancer
hypopharynx cancer
IMRT

Study placed in the following topic categories:

Mouth Diseases
Otorhinolaryngologic Neoplasms
Otorhinolaryngologic Diseases
Squamous cell carcinoma
Pharyngeal Neoplasms
Lip and oral cavity cancer
Mouth Neoplasms
Pharyngeal Diseases
Carcinoma
Epidermoid carcinoma

Hypopharyngeal Neoplasms
Cisplatin
Oral cancer
Head and Neck Neoplasms
Carcinoma, squamous cell
Hypopharyngeal cancer
Stomatognathic Diseases
Carcinoma, Squamous Cell
Carcinoma, squamous cell of head and neck
Oropharyngeal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Antineoplastic Agents

Therapeutic Uses
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009