IMRT Plus Cisplatin Versus Conventional Radiotherapy Plus Cisplatin in Stage III-IV HNSCC
This study is currently recruiting participants.
Verified June 2011 by Groupe Oncologie Radiotherapie Tete et Cou
Sponsor:
Groupe Oncologie Radiotherapie Tete et Cou
Information provided by:
Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov Identifier:
NCT00158678
First received: September 9, 2005
Last updated: June 23, 2011
Last verified: June 2011
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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 Primary Completion Date: | December 2012 (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
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 | Institut Gustave Roussy |
| Principal Investigator: | Michel Lapeyre, MD | Centre Alexis Vautrin |
More Information
Additional Information:
No publications provided
| Responsible Party: | Jean BOURHIS, MD, PhD, GORTEC |
| ClinicalTrials.gov Identifier: | NCT00158678 History of Changes |
| Other Study ID Numbers: | GORTEC 2004-01 |
| Study First Received: | September 9, 2005 |
| Last Updated: | June 23, 2011 |
| 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:
|
Carcinoma, Squamous Cell Mouth Neoplasms 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 Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013