A Phase 2 interventional study of Oxaliplatin and Folinic Acid in Patients With Colorectal Cancer With Unresectable Synchronous Metastasis in Whom Resection of the Primitive Tumour is Indicated, sponsored by Gustave Roussy, Cancer Campus, Grand Paris. Terminated at 1 site in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-02-10.
Sponsored by Gustave Roussy, Cancer Campus, Grand Paris · Phase 2, Interventional, and Treatment
The purpose of this study is to analyze the clinical tolerance of immediate preoperative chemotherapy in terms of toxicity and perioperative morbidity and mortality
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 3 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Gustave Roussy, Cancer Campus, Grand Paris is the lead sponsor of 242 studies on the registry; 65 are open to participants now.
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Exclusion Criteria:
* Systemic chemotherapy (modified FOLFOX 4) 48 hours before surgery * resection of the colorectal tumor during surgery * Resumption of FOLFOX within the month after surgery (post operative administration of 4 course of treatment and assessment of the response)
Drug: Oxaliplatin · Drug: Folinic Acid · Drug: Fluorouracile
Clinical tolerance of immediate preoperative chemotherapy
Clinical tolerance of immediate preoperative chemotherapy assessment is based on the post-operative complication rate in terms of morbidity and mortality. All the post-operative complications arising within 30 days after surgery will be registered and classified using the Clavien Dindo classification
Time frame: Assess up to 30 days after surgery
This study is terminated, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Gustave Roussy, Cancer Campus, Grand Paris