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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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00162708
Enrollment
120
Registered
2005-09-13
Start date
1996-07-01
Completion date
Unknown
Last updated
2026-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oropharynx Cancer, Oral Cancer, Hypopharynx Cancer, Larynx Cancer

Keywords

Head and neck squamous cell carcinoma, Radiotherapy, Chemotherapy

Brief 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.

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.

Interventions

PROCEDURERadiotherapy 62-64 Gy in 5 W (31-32 f. of 2 Gy BID)
PROCEDURERadiotherapy 62-64 Gy in 22-23 D (31-32 f of 2 Gy BID)

Sponsors

Gustave Roussy, Cancer Campus, Grand Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Event free survival (event = progressive disease or relapse or or death from any cause)

Secondary

MeasureTime frame
Survival
Toxicity

Countries

France

Contacts

PRINCIPAL_INVESTIGATORJean Bourhis

Gustave Roussy, Cancer Campus, Grand Paris

PRINCIPAL_INVESTIGATORMichel Lapeyre

Centre Alexis Vautrin

PRINCIPAL_INVESTIGATORJacques Tortochaux

Centre Jean Perrin

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 20, 2026