MedDataX Logo

Very Intense Radiotherapy-Chemotherapy Regimen in Advanced HNSCC

NCT ID: NCT00162708

Last Updated: 2005-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Oropharynx Cancer Oral Cancer Hypopharynx Cancer Larynx Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Head and neck squamous cell carcinoma Radiotherapy Chemotherapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

CDDP, 5 Fu

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jean Bourhis

Role: PRINCIPAL_INVESTIGATOR

Gustave Roussy, Cancer Campus, Grand Paris

Michel Lapeyre

Role: PRINCIPAL_INVESTIGATOR

Centre Alexis Vautrin

Jacques Tortochaux

Role: PRINCIPAL_INVESTIGATOR

Centre Jean Perrin

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre Jean Perrin

Clermont-Ferrand, , France

Site Status

Centre Alexis Vautrin

Nancy, , France

Site Status

Institut Gustave Roussy

Villejuif, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GORTEC

Identifier Type: -

Identifier Source: secondary_id

VADN3

Identifier Type: -

Identifier Source: org_study_id