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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Groupe Oncologie Radiotherapie Tete et Cou

ClinicalTrials.gov Identifier:

NCT00158678

First received: September 9, 2005

Last updated: March 23, 2015

Last verified: March 2015

History of Changes

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 Intervention Model: Parallel Assignment Masking: None (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:

Genetics Home Reference related topics: head and neck squamous cell carcinoma

Drug Information available for: Cisplatin

Genetic and Rare Diseases Information Center resources: Oral Cancer Lip and Oral Cavity Cancer Hypopharyngeal Cancer

U.S. FDA Resources

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

Primary Outcome Measures:

Loco regional control [ Time Frame: 2 years ]

Secondary Outcome Measures:

Survival [ Time Frame: 2 years ]
Xerostomia at 2 years (evaluated by parotid gland scintigraphy) [ Time Frame: 2 years ]
Quality of life (EORTC-QLQ-H&N35) [ Time Frame: 2 years ]


Estimated Enrollment:	310
Study Start Date:	September 2005
Estimated Study Completion Date:	February 2018
Estimated Primary Completion Date:	February 2018 (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 (Adult, Senior)
Sexes Eligible for Study:	All
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

Locations


France
Centre Alexis Vautrin
Vandoeuvre les Nancy, France, 54511
Institut Gustave Roussy
Villejuif, France, 94800

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


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:	March 23, 2015

Keywords provided by Groupe Oncologie Radiotherapie Tete et Cou:


oral cancer oropharynx cancer hypopharynx cancer IMRT

Additional relevant MeSH terms:


Mouth Neoplasms Oropharyngeal Neoplasms Hypopharyngeal Neoplasms Head and Neck Neoplasms Neoplasms by Site Neoplasms Mouth Diseases	Stomatognathic Diseases Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Pharyngeal Diseases Otorhinolaryngologic Diseases Cisplatin Antineoplastic Agents

ClinicalTrials.gov processed this record on August 22, 2017

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