Head and Neck CancerPhase 2NCT00169221
Post-operative Radiotherapy With Cisplatin Alone or in Combination With Iressa in Upper Aerodigestive Tract Carcinomas
A Phase 2 study testing Iressa (Gefitinib) and chemoradiotherapy with cisplatin in people with Head and Neck Cancer, run by Groupe Oncologie Radiotherapie Tete et Cou at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Iressa (Gefitinib) and chemoradiotherapy with cisplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2005to Jul 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- previous history of cancer (except skin basal cell carcinoma)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Head and Neck Cancer
- Being tested
- Iressa (Gefitinib), chemoradiotherapy with cisplatin
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iressa (Gefitinib)Drug
postoperative chemoradiotherapy with cisplatin + gefitinib
chemoradiotherapy with cisplatinRadiation
postoperative chemoradiotherapy with cisplatin
| Study group | Role | What they receive |
|---|---|---|
| postop chemoradio with cisplatin | Active comparator | postoperative chemoradiotherapy with cisplatin Receives: Radiation: chemoradiotherapy with cisplatin |
| postop chemoradio (cisplatin)+gefitinib | Experimental | postoperative chemoradiotherapy with cisplatin + gefitinib Receives: Drug: Iressa (Gefitinib) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionJul 2009
- Study completionJul 2011
Why it stopped: Toxicity in an independent study IMEX. The trial was subsequently terminated (54 pts instead of 140) despite safety analyses showing no excess of toxicity
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Oncologie Radiotherapie Tete et Cou
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Rene-Jean Bensadoun, MD, Principal investigator, Centre Antoine Lacassagne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00169221
- Sponsor's protocol ID
- GORTEC 2004-02
- Status last verified
- Nov 2011
- First submitted
- 12 Sep 2005
- Last updated
- 15 Nov 2011
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00169221
- Acronym / sponsor ID
- GORTEC 2004-02
- Conditions
- Head and Neck Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Toxicity in an independent study IMEX. The trial was subsequently terminated (54 pts instead of 140) despite safety analyses showing no excess of toxicity
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Groupe Oncologie Radiotherapie Tete et CouUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Sep 2005
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| postop chemoradio with cisplatin | Active comparator | Radiation: chemoradiotherapy with cisplatinpostoperative chemoradiotherapy with cisplatin |
| postop chemoradio (cisplatin)+gefitinib | Experimental | Drug: Iressa (Gefitinib)postoperative chemoradiotherapy with cisplatin + gefitinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- previous history of cancer (except skin basal cell carcinoma)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iressa (Gefitinib)postoperative chemoradiotherapy with cisplatin + gefitinib | Drug | postop chemoradio (cisplatin)+gefitinib |
| chemoradiotherapy with cisplatinpostoperative chemoradiotherapy with cisplatin | Radiation | postop chemoradio with cisplatin |
Primary outcome
Disease free survival
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Toxicity in an independent study IMEX. The trial was subsequently terminated (54 pts instead of 140) despite safety analyses showing no excess of toxicity). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2011.
- Derived from this study: PubMed 22855581Thariat 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rene-Jean Bensadoun, MD principal investigator
Centre Antoine Lacassagne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iressa (Gefitinib) and chemoradiotherapy with cisplatin in people with Head and Neck Cancer, run by Groupe Oncologie Radiotherapie Tete et Cou at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Toxicity in an independent study IMEX. The trial was subsequently terminated (54 pts instead of 140) despite safety analyses showing no excess of toxicity). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00169221, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2011.