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NCT Number: NCT00162708

Very Intense Radiotherapy-Chemotherapy Regimen in Advanced HNSCC

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.

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Key information

Conditions

Oropharynx Cancer Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Hypopharyngeal Neoplasms Hypopharynx Cancer Laryngeal Diseases Laryngeal Neoplasms Larynx Cancer Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Oral Cancer Oropharyngeal Neoplasms Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Squamous Cell Carcinoma of Head and Neck Stomatognathic Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Centre Jean Perrin, Clermont-Ferrand, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Procedure

CDDP, 5 Fu

Drug

Primary outcomes

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

Secondary outcomes

  1. Survival

  2. Toxicity

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Registry information

Official study title

A Randomized Trial Evaluating a Very Intense Radiotherapy-Chemotherapy Regimen Versus a Very Accelerated Radiotherapy in Advanced Head and Neck Squamous Cell Carcinoma

Important dates

Study start
1996
First posted
Sep 13, 2005
Registry last updated
Sep 13, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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