Very Intense Radiotherapy-Chemotherapy Regimen in Advanced HNSCC

Oral Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00162708
• Other study ID #: VADN3
• Secondary ID: GORTEC
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 9, 2005
• Last updated: September 9, 2005
• Start date: July 1996

Study information

• Verified date: September 2005
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Hypopharynx Cancer
• Larynx Cancer
• Oral Cancer
• Oropharynx Cancer

Intervention

Procedure:
• Radiotherapy 62-64 Gy in 5 W (31-32 f. of 2 Gy BID)

• Radiotherapy 62-64 Gy in 22-23 D (31-32 f of 2 Gy BID)

Drug:
• CDDP, 5 Fu

Locations

Country	Name	City	State
France	Centre Jean Perrin	Clermont-Ferrand
France	Centre Alexis Vautrin	Nancy
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event free survival (event = progressive disease or relapse or or death from any cause)
Secondary	Survival
Secondary	Toxicity