Colectomy in Patients With Asymptomatic and Unresectable Stage IV Colon Cancer (CLIMAT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02363049|
Recruitment Status : Unknown
Verified February 2017 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was: Recruiting
First Posted : February 13, 2015
Last Update Posted : February 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Malignant Neoplasm of Large Intestine Colon Cancer Liver Metastasis||Procedure: Colectomy Drug: Chemotherapy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||278 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Phase III Study Assessing the Interest of Primary Tumor Resection in Patients With Asymptomatic Colon Cancer and Unresectable Synchronous Liver Metastases.|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2018|
surgery followed by chemotherapy +/- targeted therapy regime according to each centre
Active Comparator: no colectomy
Chemotherapy +/- targeted therapy alone, regime according to each centre.
- overall survival [ Time Frame: 2 years ]
- quality of life [ Time Frame: 2 years ]Questionnaire QLQ-C30 et QLQ-CR29 in both treatment arms Time frame : one month after surgery in arm A, one month after the beginning of chemotherapy in arm B and then each 3 months in both treatment arms up to 2 years
- Post-operative complications [ Time Frame: 30 days ]Post-operative complications (surgical or medical) will be graded according to the Clavien-Dindo system
- Progression free survival (PFS) [ Time Frame: 2 years ]
PFS is defined as the time interval between the date of randomization and the first date of progression of the metastatic disease or death in both treatment arms.
Time frame: each 3 months up to 2 years.
- Time to metastatic progression (TTP) [ Time Frame: 2 years ]TTP is defined as the time interval between the date of randomization and the first date of progression of the metastatic disease or death in both treatment arms in both treatment arms Time frame: each 3 months up to 2 years.
- Rate of secondary curative resection (R0) [ Time Frame: 1 year ]The rate of secondary curative resection will be assessed in both treatment arms and will concern resection of both the PT and the metastatic disease Time frame: each 3 months up to 12 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02363049
|Contact: Mehdi Karoui, MD, PhD||+331-42-17-56-51|
|Groupe hospitalier Pitié Salpetriere||Recruiting|
|Paris, France, 75013|
|Contact: Mehdi Karoui, MD, PhD|
|Principal Investigator:||Mehdi Karoui, MD, PhD||Assistance Publique - Hôpitaux de Paris|