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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Oral Cancer; Oropharynx Cancer; Hypopharynx Cancer	Procedure: IMRT 75 Gy; Procedure: Conventional radiotherapy 70 Gy; Drug: concomitant cisplatin	Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	310 participants
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
Study Start Date :	September 2005
Estimated Primary Completion Date :	December 2018
Estimated Study Completion Date :	December 2018

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Loco regional control [ Time Frame: 2 years ]

Secondary Outcome Measures :

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

Eligibility Criteria

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Additional Information:

Related Info 

Responsible Party:	Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov Identifier:	NCT00158678 History of Changes
Other Study ID Numbers:	GORTEC 2004-01
First Posted:	September 12, 2005
Last Update Posted:	February 16, 2018
Last Verified:	February 2018

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