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TerminatedNCT00169221Updated Nov 15, 2011

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

A Phase 2 interventional study of Iressa (Gefitinib) and chemoradiotherapy with cisplatin in Head and Neck Cancer, sponsored by Groupe Oncologie Radiotherapie Tete et Cou. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-11-15.

Sponsored by Groupe Oncologie Radiotherapie Tete et Cou · Phase 2, Interventional, and Treatment

Why this study was terminated
Toxicity in an independent study IMEX. The trial was subsequently terminated (54 pts instead of 140) despite safety analyses showing no excess of toxicity
Phase
Phase 2
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

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.

02

Conditions studied

  • Head and Neck Cancer
03

In context

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.

This study's enrollment of 54 is above the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

Groupe Oncologie Radiotherapie Tete et Cou is the lead sponsor of 32 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • previous history of cancer (except skin basal cell carcinoma)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
54 participants (actual)

Study arms

  • Active comparator
    postop chemoradio with cisplatin

    postoperative chemoradiotherapy with cisplatin

    Radiation: chemoradiotherapy with cisplatin

  • Experimental
    postop chemoradio (cisplatin)+gefitinib

    postoperative chemoradiotherapy with cisplatin + gefitinib

    Drug: Iressa (Gefitinib)

Interventions

  • DrugIressa (Gefitinib)

    postoperative chemoradiotherapy with cisplatin + gefitinib

  • Radiationchemoradiotherapy with cisplatin

    postoperative chemoradiotherapy with cisplatin

06

What researchers measure

Primary outcomes

  1. Disease free survival

    Time frame: 3 years

07

Study locations

1 site
  • Centre Antoine Lacassagne
    Nice, 06189, France
08

References and documents

Publications

  • 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. PubMed 22855581 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00169221
Lead sponsor
Groupe Oncologie Radiotherapie Tete et Cou
Collaborators
AstraZeneca
Responsible party
Sponsor
First posted
Sep 15, 2005
Start date
Sep 2005
Primary completion
Jul 2009
Completion
Jul 2011
Last update
Nov 15, 2011

Study contacts

Rene-Jean Bensadoun, MD
principal investigator · Centre Antoine Lacassagne
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

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