Trial | NCT00162708  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    fluorouracil cisplatin ...

  • Study Participants

    120
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.
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 Started
Jul 31
1996
Last Update
Sep 13
2005
Estimate

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

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
No Results Posted