Cancer of the RectumPhase 3NCT00189657
5FU/VL Vs LV5FU2 + CPT11 in Stage II-III Resected Rectal Cancer
A Phase 3 study testing 5FU/LV Mayo Clinic or LV5FU2 and LV5FU2 + irinotecan in people with Cancer of the Rectum, run by Association Européenne de Recherche en Oncologie at 1 site in France.
Trial summary
The main objective of this randomized trial is to compare 5FU/LV (Mayo-Clinic regimen or LV5FU2) to LV5FU2 + irinotécan in patients with resected B2 and C rectal cancer. Preoperative radiotherapy is recommended but not mandatory. Main endpoint is disease free survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of the Rectum
- What is being tested?
- 5FU/LV Mayo Clinic or LV5FU2 and LV5FU2 + irinotecan
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteFrance
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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
- Adult, Older adult
Who may be able to join
- rectal adenocarcinoma
- R0 surgery
- T3, N0, M0 or T4, N0, M0 or N1,2, M0
- chemotherapy can be started within 8 weeks after surgery
- Age > 18
- Performance status ECOG < 3
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- preoperative radiotherapy allowed
- preoperative chemotherapy with 5FU +/- LV allowed
- Neutrophiles > 1 500/mm3; Pl. > 100 000/mm3
- Transaminases < 2 x UNL; Alcalines Phosphatases < 2 x UNL; Bili < 1.1 UNL
- creatininemia < 120 µmol/l and/or clearance of creatininemia > 60 ml/mn
- Written informed consent before inclusion
Who cannot join
- postoperative radiotherapy
- Distant metastases
- Contraindication to any drug contained in the chemotherapy regimens
- Any serious active disease or co-morbid medical condition including digestive inflammatory disease
- Gilbert disease
- severe toxicity of radiotherapy
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- Pregnancy or breast feeding
- Absence of contraception in non menopausal women
- Adult patient unable to give informed consent because of intellectual impairment
- Concomitant participation to another trial
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
AERO
Créteil, 94000
Pascal Piedbois, MD, + 33 1 49 81 25 82, pascal.piedbois@hmn.aphp.fr
About this study
The main objective of this randomized trial is to compare 5FU/LV (Mayo-Clinic regimen or LV5FU2) to LV5FU2 + irinotécan in patients with resected B2 and C rectal cancer. Preoperative radiotherapy is recommended but not mandatory. Main endpoint is disease free survival. Secondary endpoint are overall survival, time to local recurrence, time to distant metastases, and tolerance. A total of 600 patients will be included in the trial.
- Conditions
- Cancer of the Rectum
- Being tested
- 5FU/LV Mayo Clinic or LV5FU2, LV5FU2 + irinotecan
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5FU/LV Mayo Clinic or LV5FU2Procedure or surgery
LV5FU2 + irinotecanProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of the RectumStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Association Européenne de Recherche en Oncologie
- Sponsor type
- University, hospital or other
- Collaborators
- Aventis Pharmaceuticals, Pfizer
- Investigators
- Pascal Piedbois, MD, Principal investigator, Association Europeenne de Recherche en OncologieThierry Andre, MD, Principal investigator, GERCOR - Multidisciplinary Oncology Cooperative GroupAlain Piolot, MD, Principal investigator, Association Europeenne de Recherche en OncologieEmmanuel Achille, MD, Principal investigator, GERCOR - Multidisciplinary Oncology Cooperative GroupIradj Bobhani, MD, Principal investigator, Fondation Française de Cancérologie DigestiveJean-Yves Douillard, MD, Principal investigator, UNICANCER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00189657
- Sponsor's protocol ID
- AERO-R98
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 19 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 5FU/VL Vs LV5FU2 + CPT11 in Stage II-III Resected Rectal Cancer
- ClinicalTrials.gov ID
- NCT00189657
- Acronym / sponsor ID
- AERO-R98
- Conditions
- Cancer of the Rectum
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Association Européenne de Recherche en OncologieUniversity, hospital or other
- Collaborators
- Aventis Pharmaceuticals, Pfizer
- First posted
- 19 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.
The main objective of this randomized trial is to compare 5FU/LV (Mayo-Clinic regimen or LV5FU2) to LV5FU2 + irinotécan in patients with resected B2 and C rectal cancer. Preoperative radiotherapy is recommended but not mandatory. Main endpoint is disease free survival. Secondary endpoint are overall survival, time to local recurrence, time to distant metastases, and tolerance. A total of 600 patients will be included in the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- rectal adenocarcinoma
- R0 surgery
- T3, N0, M0 or T4, N0, M0 or N1,2, M0
- chemotherapy can be started within 8 weeks after surgery
- Age > 18
Key exclusion criteria (10 listed)
- postoperative radiotherapy
- Distant metastases
- Contraindication to any drug contained in the chemotherapy regimens
- Any serious active disease or co-morbid medical condition including digestive inflammatory disease
- Gilbert disease
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 |
|---|---|---|
| 5FU/LV Mayo Clinic or LV5FU2 | Procedure or surgery | – |
| LV5FU2 + irinotecan | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2005.
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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.
Pascal Piedbois, MD principal investigator
Association Europeenne de Recherche en Oncologie
Thierry Andre, MD principal investigator
GERCOR - Multidisciplinary Oncology Cooperative Group
Alain Piolot, MD principal investigator
Association Europeenne de Recherche en Oncologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 5FU/LV Mayo Clinic or LV5FU2 and LV5FU2 + irinotecan in people with Cancer of the Rectum, run by Association Européenne de Recherche en Oncologie 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 12 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 19 Sep 2005. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annie JOUHAUD (+ 33 1 43 77 72 10, annie.jouhaud@aero-eu.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 19 Sep 2005.