Very Intense Radiotherapy-Chemotherapy Regimen in Advanced HNSCC

Gustave Roussy

Status and phase

Completed

Phase 3

Phase 2

Conditions

Oropharynx Cancer

Hypopharynx Cancer

Larynx Cancer

Oral Cancer

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT00162708

VADN3

GORTEC

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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