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Multicenter Phase II study of modified FOLFOX7(combination chemotherapy of infusional 5-FU/l-Leucovorin and intermittent Oxaliplatin)with bevacizumab in the first-line therapy of colorectal cancer - CRAFT trial-

ABSTRACT: Interventions: (mFOLFOX7+bevacizumab)x8cycle followed by (sLV5FU2+bevacizumab)x8cycle, followed by (mFOLFOX7+bevacizumab)x8cycle is treated until progression Primary outcome(s): Progression Free Survival Study Design: Single arm Non-randomized

DISEASE(S): Advanced Colorectal Cancer

PROVIDER: 2617832 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Pharmacogenomic study on colorectal cancer chemotherapy - modified FOLFOX6- (Oxaliplatin with infusional 5-FU/l-Leucovorin) and FOLFIRI (irinotecan with infusional 5-FU/l-Leucovorin)-based regimen-

Project description:Interventions: mFOLFOX6 (-BEV): On Day1, iv infusion of 85 mg/m2 of l-OHP and 175 mg/m2 of L-LV for 2hrs, followed by bolus infusion of 400 mg/m2 5-FU. Then, continuous infusion of 2400 mg/m2 5-FU for 46 hrs. 1 course, 2 weeks. Continue the courses till the discontinuance criteria. mFOLFOX6 (+BEV): The first treatment after the surgery is subject to the mFOLFOX6 (-BEV) regimen. From the 2nd cycle, first infusion of 5 mg/kg BEV. Then follow the mFOLFOX6 (-BEV) regimen. 1 course, 2 weeks. Continue the courses till the discontinuance criteria. mFOLFIRI(-BEV): On Day1, iv infusion of 150 mg/m2 of CPT-11 and 175 mg/m2 of L-LV for 2 hrs, followed by bolus infusion of 400 mg/m2 5-FU. Then, continuous infusion of 2400 mg/m2 5-FU for 46 hrs. 1 course, 2 weeks. Continue the courses till the discontinuance criteria. mFOLFIRI (+BEV): The first treatment after the surgery is subject to the FOLFIRI (-BEV) regimen. From the 2nd cycle, first infusion of 5 mg/kg BEV. Then follow the FOLFIRI (-BEV) regimen. 1 course, 2 weeks. Continue the courses till the discontinuance criteria. Primary outcome(s): Response rate (RECISTv1.1) Study Design: Parallel Randomized

| 2622327 | ecrin-mdr-crc

Feasibility of perioperative chemotherapy with infusional 5-FU, leucovorin, and oxaliplatin with (FLOT) or without (FLO) docetaxel in elderly patients with locally advanced esophagogastric cancer.

Project description:The aim of this exploratory subgroup analysis of the fluorouracil, oxaliplatin, docetaxel (FLOT)65+ trial was to determine tolerability and feasibility of perioperative chemotherapy in elderly, potentially operable esophagogastric cancer patients.Patients aged ≥65 with locally advanced esophagogastric adenocarcinoma were randomized to perioperative chemotherapy consisting of four pre- and four postoperative cycles of infusional 5-FU, leucovorin, and oxaliplatin (FLO) without or with docetaxel 50 mg m(-)(2) (FLOT), every 2 weeks.Forty-four patients with a median age of 70 years were randomized and 43 patients started preoperative chemotherapy (FLO, 22; FLOT, 21). Thirty-eight (86.4%) patients completed four cycles of preoperative chemotherapy and 32 (74.4%) proceeded to surgery, with 67.4% R0 resections on intent-to-treat analysis (90.1% of the 32 patients who underwent resection). Median overall survival was not reached and median progression-free survival (PFS) was 17.3 months. Compared with the FLO group, the FLOT group showed a trend towards an improved median PFS (21.1 vs 12.0 months; P=0.09), however, associated with increased chemotherapy related toxicity. No perioperative mortality was observed. Postoperative morbidity was observed in 46.9% of patients (FLO, 35.3%; FLOT, 60%).Neoadjuvant FLO or FLOT may offer a reasonable chance of curative surgery in elderly patients with locally advanced resectable gastroesophageal cancer. However, the increase in side effects with the FLOT regimen and postoperative morbidity should be carefully considered when an intensive chemotherapy regimen is planned.

| S-EPMC3593547 | biostudies-other

Pharmacogenomic study of modified FOLFOX6 (combination chemotherapy of Oxaliplatin with infusional 5-FU/l-Leucovorin) in colorectal cancer

Project description:Interventions: Intravenous administration of l-Leucovorin 175 mg/body, Oxaliplatin 85 mg/m2 as a 2-hour infusion followed by bolus 5-FU 400 mg/m2 and 46hr infusion 5-FU 2,400 mg/m2 every two weeks Primary outcome(s): Response rate(best tumor shrinkage(rate)) Study Design: Single arm Non-randomized

| 2609819 | ecrin-mdr-crc

Clinical Efficacy and Safety Assessment of Oxaliplatin and Fluorouraciland, Leucovorin [modified FOLFOX6] in Combination with High-dose Bevacizumab as Second-line Therapy in Patients with Advanced or Recurrent Colorectal Cancer after Failure to Irinotecan. Multicenter Clinical Study.

Project description:Interventions: High-dose Bevacizumab + sLV5FU2 Bevacizumab 10mg/kg (d.i.v) L-OHP 85 mg/m2 (d.i.v) l-LV 200mg/m2 (d.i.v) 5-FU 400mg/m2 (b.i.v) 5-FU 2400mg/m2 (c.i.v) Every 2weeks Primary outcome(s): Progression free survival [PFS] Study Design: Single arm Non-randomized

| 2625142 | ecrin-mdr-crc

Phase II clinical trial of the first-line Stop-and-Go modified FOLFOX6 and bevacizmab for patients with unresectable/recurrent colorectal cancer

Project description:Interventions: After 8 cycles of modified FOLFOX 6 with bevacizmab, patients receive sLV5FU2 with bevacizumab (until 8 cycles are completed or disease progression). And then, patients receive modified FOLFOX6 with bevacizmab (until 8 cycles are completed or disease progression.) Primary outcome(s): Response rate Study Design: Single arm Non-randomized

| 2616726 | ecrin-mdr-crc

Clinical efficacy and safety assessment of high-dose Bevacizumab plus Fluorouracil and Leucovorin (sLV5FU2) in patients with standard chemotherapy refractory metastatic colorectal cancer. phase II multicenter trial.

Project description:Interventions: High-dose Bevacizumab + sLV5FU2 Bevacizumab 10mg/kg (d.i.v) l-LV 200mg/m2 (d.i.v) 5-FU 400mg/m2 (b.i.v) 5-FU 2400mg/m2 (c.i.v) Every 2weeks Primary outcome(s): Progression-free survival Study Design: Single arm Non-randomized

| 2625196 | ecrin-mdr-crc

Phase II study of Bevacizumab plus modified OPTIMOX1 in patients with unresectable advanced/recurrent colorectal cancer

Project description:Interventions: 1-6 Course Bevacizumab+mFOLFOX6 7-18 Course Bevacizumab+sLV5FU2 19- Course Bevacizumab+mFOLFOX6 Primary outcome(s): Duration of disease control Study Design: Single arm Non-randomized

| 2616624 | ecrin-mdr-crc

Oxaliplatin/capecitabine vs oxaliplatin/infusional 5-FU in advanced colorectal cancer: the MRC COIN trial.

Project description:COIN compared first-line continuous chemotherapy with the same chemotherapy given intermittently or with cetuximab in advanced colorectal cancer (aCRC).Choice between oxaliplatin/capecitabine (OxCap) and oxaliplatin/leucovorin (LV)/infusional 5-FU (OxFU) was by physician and patient choice and switching regimen was allowed. We compared OxCap with OxFU and OxCap+cetuximab with OxFU+cetuximab retrospectively in patients and examined efficacy, toxicity profiles and the effect of mild renal impairment.In total, 64% of 2397 patients received OxCap(± cetuximab). Overall survival, progression free survival and overall response rate were similar between OxCap and OxFU but rate of radical surgeries was higher for OxFU. Progression free survival was longer for OxFU+cetuximab compared with OxCap+cetuximab but other efficacy measures were similar. Oxaliplatin/LV/infusional 5-FU (± cetuximab) was associated with more mucositis and infection whereas OxCap(± cetuximab) caused more gastrointestinal toxicities and palmar-plantar erythema. In total, 118 patients switched regimen, mainly due to toxicity; only 16% came off their second regimen due to intolerance. Patients with creatinine clearance (CrCl) 50-80 ml min(-1) on OxCap(± cetuximab) or OxFU+cetuximab had more dose modifications than those with better renal function.Overall, OxFU and OxCap are equally effective in treating aCRC. However, the toxicity profiles differ and switching from one regimen to the other for poor tolerance is a reasonable option. Patients with CrCl 50-80 ml min(-1) on both regimens require close toxicity monitoring.

| S-EPMC3461171 | biostudies-other

Gene expression profile of FFPE samples collected with translational purposes from the MITO16/MaNGO-OV2 clinical trial

Project description:MITO16/MaNGO-OV2 (NCT01706120) is a multicenter, phase IV, single arm trial for advanced stage IIIB-IV or recurrent, previously untreated, ovarian cancer patients receiving carboplatin, paclitaxel plus bevacizumab for six 3-weekly cycles followed by bevacizumab single agent until progression or unacceptable toxicity up to a maximum of 22 total cycles. The trial that was specifically designed with a translational primary endpoint to explore if selected clinical and biological factors could identify ovarian cancer patients with better prognosis in terms of progression free survival and overall survival after combined first-line treatment with chemotherapy plus Bevacizumab. The translational study, designed together with the clinical trial, the translational study implicated the collection of patients’ tissue (formalin-fixed paraffin-embedded – FFPE) and blood samples. Gene expression profile was among the molecular analyses proposed on FFPE samples.

2023-04-19 | GSE208103 | GEO

Assessment of clinical efficacy and safety in capecitabine plus intermittent oxaliplatin (intermittent CapeOx)together with Bevacizumab as the first-line therapy for patients with advanced colorectal cancer; multicenter phase II trial

Project description:Interventions: capecitabine plus intermittent oxaliplatin (CapeOx) in combination with Bevacizumab: (CapeOx + Bevacizumab)x5 cycles followed by (Capecitabine + Bevacizumab )x5 cycles, followed by (CapeOx + Bevacizumab)x5 cycles are administered until progression. [CapeOx + Bevacizumab] Capecitabine: 2000mg/m2/day p.o. (day1-15) Oxaliplatin: 130mg/m2 i.v. (day1) Bevacizumab: 7.5mg/kg i.v. (day1) to be repeated every 3 weeks [Capecitabine + Bevacizumab] Capecitabine: 2000mg/m2/day p.o. (day1-15) Bevacizumab: 7.5mg/kg i.v. (day1) to be repeated every 3 weeks Primary outcome(s): progression free survival (PFS) Study Design: Single arm Non-randomized

| 2621169 | ecrin-mdr-crc

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