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Very Intense Radiotherapy-Chemotherapy Regimen in Advanced HNSCC

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ClinicalTrials.gov Identifier: NCT00162708
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : September 13, 2005
Sponsor:
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary:
Altered fractionated radiotherapy and concomitant radio-chemotherapy have been shown to be two possibilities for improving efficacy of radiotherapy in locally advanced head and neck carcinomas. In this multicentric study, we tested the hypothesis that accelerated radiotherapy could be delivered concomitantly with conventional high doses of CDDP-5FU, aiming to improve both local control and on distant metastases as compared to very accelerated radiotherapy.

Condition or disease Intervention/treatment Phase
Oropharynx Cancer Oral Cancer Hypopharynx Cancer Larynx Cancer Procedure: Radiotherapy 62-64 Gy in 5 W (31-32 f. of 2 Gy BID) Procedure: Radiotherapy 62-64 Gy in 22-23 D (31-32 f of 2 Gy BID) Drug: CDDP, 5 Fu Phase 2 Phase 3

Detailed Description:
Patients with a palpable N2b-c or N3 HNSCC strictly unresectable were randomized to receive either accelerated RT-CT delivering to the primary tumor 62-64 Gy / 5 weeks in 31-32 fractions of 2 Gy BID or very accelerated RT delivering 62-64 Gy in 31-32 fractions of 2 Gy BID and 22-23 days. In the accelerated RT-CT arm, 3 cycles of CDDP 100 mg/m2 were delivered at day 1, 16, 32 and 2 cycles of 5 Fu 1000 mg/m2 day 1 to 5 and 31 to 35. One month after completion of the concomitant RT-CT, 2 additional cycles of CDDP-5FU were given in patients responding (> 50%) to the initial course of RT-CT. The end points were event free survival and survival.

Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial Evaluating a Very Intense Radiotherapy-Chemotherapy Regimen Versus a Very Accelerated Radiotherapy in Advanced Head and Neck Squamous Cell Carcinoma
Study Start Date : July 1996





Primary Outcome Measures :
  1. Event free survival (event = progressive disease or relapse or or death from any cause)

Secondary Outcome Measures :
  1. Survival
  2. Toxicity


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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • palpable N2b-c or N3 (UICC 1997) squamous cell carcinoma of the head and neck (oropharynx, oral cavity, hypopharynx or larynx)
  • primary tumor and / or nodal extension strictly inoperable due to the extension of the disease
  • performance status of 0 to 2 (WHO scoring system)
  • renal/liver/cardiac functions and blood counts compatible with the use of CDDP and 5-FU
  • signed inform consent

Exclusion Criteria:

  • distant metastasis
  • previous history of cancer
  • previous radiotherapy or chemotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00162708


Locations
France
Centre Jean Perrin
Clermont-Ferrand, France
Centre Alexis Vautrin
Nancy, France
Institut Gustave Roussy
Villejuif, France, 94800
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
Principal Investigator: Jean Bourhis Gustave Roussy, Cancer Campus, Grand Paris
Principal Investigator: Michel Lapeyre Centre Alexis Vautrin
Principal Investigator: Jacques Tortochaux Centre Jean Perrin

ClinicalTrials.gov Identifier: NCT00162708     History of Changes
Other Study ID Numbers: VADN3
GORTEC
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: September 13, 2005
Last Verified: September 2005

Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:
Head and neck squamous cell carcinoma
Radiotherapy
Chemotherapy

Additional relevant MeSH terms:
Mouth Neoplasms
Oropharyngeal Neoplasms
Laryngeal Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms