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Post-operative Radiotherapy With Cisplatin Alone or in Combination With Iressa in Upper Aerodigestive Tract Carcinomas

NCT ID: NCT00169221

Last Updated: 2011-11-15

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

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2011-07-31

Brief Summary

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This trial will be an open multicentric randomized phase II study comparing post-operative radiotherapy + cisplatin associated or not with Iressa in upper aerodigestive tract carcinomas.

Detailed Description

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Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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postop chemoradio with cisplatin

postoperative chemoradiotherapy with cisplatin

Group Type ACTIVE_COMPARATOR

chemoradiotherapy with cisplatin

Intervention Type RADIATION

postoperative chemoradiotherapy with cisplatin

postop chemoradio (cisplatin)+gefitinib

postoperative chemoradiotherapy with cisplatin + gefitinib

Group Type EXPERIMENTAL

Iressa (Gefitinib)

Intervention Type DRUG

postoperative chemoradiotherapy with cisplatin + gefitinib

Interventions

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Iressa (Gefitinib)

postoperative chemoradiotherapy with cisplatin + gefitinib

Intervention Type DRUG

chemoradiotherapy with cisplatin

postoperative chemoradiotherapy with cisplatin

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Patients with upper aerodigestive tract carcinomas (all sites included) having surgical resection and eligible for post-operative radiation + cisplatin.
* Patient having a tumoral biopsy (0.5 - 1 cm3) stored in liquid nitrogen at time of surgical resection (patients with small tumors located in larynx for instance will not be included)
* Patients receiving post-operative radiation (\>=60 Gy on tumor bed and/or cervical area), associated with cisplatin, 6 weeks after surgery at the latest.

Exclusion Criteria

* previous history of cancer (except skin basal cell carcinoma)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

Groupe Oncologie Radiotherapie Tete et Cou

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rene-Jean Bensadoun, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Antoine Lacassagne

Locations

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Centre Antoine Lacassagne

Nice, , France

Site Status

Countries

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France

References

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Thariat J, Bensadoun RJ, Etienne-Grimaldi MC, Grall D, Penault-Llorca F, Dassonville O, Bertucci F, Cayre A, De Raucourt D, Geoffrois L, Finetti P, Giraud P, Racadot S, Moriniere S, Sudaka A, Van Obberghen-Schilling E, Milano G. Contrasted outcomes to gefitinib on tumoral IGF1R expression in head and neck cancer patients receiving postoperative chemoradiation (GORTEC trial 2004-02). Clin Cancer Res. 2012 Sep 15;18(18):5123-33. doi: 10.1158/1078-0432.CCR-12-1518. Epub 2012 Aug 1.

Reference Type DERIVED
PMID: 22855581 (View on PubMed)

Other Identifiers

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GORTEC 2004-02

Identifier Type: -

Identifier Source: org_study_id