A Phase 2 interventional study of LV5FU2 simplified, FOLFOX 4 simplified, FOLFIRI modified and LV5FU2 simplified,FOLFOX 4 simplified, FOLFIRI modified, Bevacizumab 5 mg/kg/ 2 weeks in Metastatic Colorectal Adenocarcinoma, sponsored by Centre Hospitalier Universitaire Dijon. Completed at 1 site in France. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2018-12-27.
Sponsored by Centre Hospitalier Universitaire Dijon · Phase 2, Interventional, and Other
To evaluate tolerance to and efficacy of bevacizumab in the treatment of MCRC in elderly patients, we propose a phase II randomised study comparing a chemotherapy + bevacizumab arm with a chemotherapy alone arm in the first-line treatment of MCRC in patients aged 75 years and older.
This study is destined to continue as a phase III trial if both arms meet the selection criteria to show or not the benefits of treatment with bevacizumab combined with chemotherapy.
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's enrollment of 102 is above the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →Centre Hospitalier Universitaire Dijon is the lead sponsor of 495 studies on the registry; 105 are open to participants now.
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Exclusion Criteria:
* LV5FU2 simplified, * 5-fluorouracil/leucovorin with oxaliplatin 4 (FOLFOX) simplified, * fluorouracil, leucovorin, and irinotecan(FOLFIRI) modified.
Drug: LV5FU2 simplified, FOLFOX 4 simplified, FOLFIRI modified
* LV5FU2 simplified, * FOLFOX 4 simplified, * FOLFIRI modified. * Bevacizumab 5 mg/kg/ 2 weeks
Drug: LV5FU2 simplified,FOLFOX 4 simplified, FOLFIRI modified, Bevacizumab 5 mg/kg/ 2 weeks
Initial examination
thoraco-abdomino-pelvic tomodensitometry or thoracic tomodensitometry and abdomino-pelvic MRI with identification and measurement of the target tumors according to RECIST (Response Evaluation Criteria in Solid Tumors )criteria.
Time frame: 21 days before the first course of treatment
Initial examination
Medical history, clinical examination (HR, arterial blood pressure , temperature, weight, height, Eastern Cooperative Oncology Group performance status), * measurement of body surface area, ECG * completion of questionnaire by the patient (annexe 1), * completion of geriatric questionnaire "team" (annexe 2) * biological examination including: * full blood count-platelets * blood electrolyte panel, creatinemia * Albumin * ASAT, ALAT, PAL, GGT, total and conjugated bilirubin * CEA, CA 19.9, LDH markers * balanced INR for patients on AVK * Urinary dip with 24-hour proteinuria if \> 1+ * Measurement of creatinine clearance using the Cockcroft formula (in men: (140-age) x weight (kg)/0.814 x creatinemia (μmol), in women: (140-age) x weight (kg)/0.85 x creatinemia (μmol)), * In the absence of a cardiological examination in the year before or in the case of a history of severe cardiovascular disease: consultation in cardiology.
Time frame: 14 days before inclusion
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire Dijon