Clinical trial · Interventional
Post-operative Radiotherapy With Cisplatin Alone or in Combination With Iressa in Upper Aerodigestive Tract Carcinomas
CARISSA Trial - Multicenter Randomized Phase II Trial Comparing Post-operative Radiotherapy and Cisplatin Alone or in Combination With the EGFR Inhibitor ZD 1839 (Iressa) in Upper Aerodigestive Tract Carcinomas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Toxicity in an independent study IMEX. The trial was subsequently terminated (54 pts instead of 140) despite safety analyses showing no excess of toxicity
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemoradiotherapy with cisplatin | Radiation | — | UNRESOLVED |
| Iressa (Gefitinib) | Drug | Gefitinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- postop chemoradio with cisplatin
- description
- postoperative chemoradiotherapy with cisplatin
- interventionNames
- Radiation: chemoradiotherapy with cisplatin
- type
- EXPERIMENTAL
- label
- postop chemoradio (cisplatin)+gefitinib
- description
- postoperative chemoradiotherapy with cisplatin + gefitinib
- interventionNames
- Drug: Iressa (Gefitinib)
Primary outcomes (1)
- measure
- Disease free survival
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDThariat 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. PMID 22855581