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Very Intense Radiotherapy-Chemotherapy Regimen in Advanced HNSCC

This study has been completed.
Sponsor:
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT00162708
First received: September 9, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

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

Secondary Outcome Measures:
  • Survival
  • Toxicity

Estimated Enrollment: 120
Study Start Date: July 1996
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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
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
  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: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00162708     History of Changes
Other Study ID Numbers: VADN3, GORTEC
Study First Received: September 9, 2005
Last Updated: September 9, 2005
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell

ClinicalTrials.gov processed this record on November 25, 2014