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Phase2 trial of Preoperative chemotherapy with XELOX prus Bv for resectable liver metastases from colorectal cancer

ABSTRACT: Interventions: Treatment is administered every 3 weeks until evidence of progression, unacceptable toxicity, patient refusal, or for 4 cycles. Primary outcome(s): disease control rate Study Design: Single arm Non-randomized

DISEASE(S): Colon Cancer

PROVIDER: 2623342 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Phase I/II Trial of Bevacizumab in Combination With FOLFOXIRI As First-Line Therapy in Colorectal Cancer Patients With Liver Metastases

Project description:Interventions: Treatment is administered every 2 weeks until evidence of DLT, progression, unacceptable toxicity, patient refusal, or for a maximum of 2 cycles to assess the feasibility. (phase I) Treatment is administered every 2 weeks until evidence of progression, unacceptable toxicity, patient refusal, or for a maximum of 6 cycles to assess the rate of resection of liver metastases achieved after treatment with 6 cycles. (phase II) Primary outcome(s): RD (phase I) Resection rate of liver metastases (phase II) Study Design: Single arm Non-randomized

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Phase II Trial of Bevacizumab in Combination with XELOX in Colorectal Cancer Patients with Liver Metastases (H2, H3)

Project description:Interventions: Treatment is administered every 3 weeks until evidence of progression, unacceptable toxicity, patient refusal, or for a maximum of 9 cycles. During the treatment, image assessment is repeated every 3 cycles, and if liver metastases could be converted resectable, liver resection is performed. Primary outcome(s): resection rate of liver metastases Study Design: Single arm Non-randomized

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Phase II trial of FOLFIRI plus Bevacizumab in second-line therapy after progression on bevacizumab with oxaliplatine-based chemotherapy in patients with metastatic colorectal cancer whose KRAS status are investigated.

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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

FOLFOX plus bevacizumab alternated with sLV5FU2 plus bevacizumab as first-line chemotherapy for patients with metastatic colorectal cancer: a feasibility study

Project description:Interventions: Treatment consisted of modified mFOLFOX6 plus bevacizumab alternated biweekly with 5-FU/LV (simplified LV5FU2) plus bevacizumab. Treatment was administered until tumor progression, unacceptable toxicity or patient refusal. Primary outcome(s): Response rate Safety Study Design: Single arm Non-randomized

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The Efficacy of Bevacizumab Combined With m-FOLFOXIRI in Borderline Resectable Colorectal Liver Metastases

Project description:This single-arm study will evaluate the resection rate of liver metastases in patients with metastatic colorectal cancer and borderline unresectable liver metastases receiving treatment with bevacizumab in combination with modified-FOLFOXIRI as first line treatment. Patients will receive bevacizumab (5 mg/kg) plus modified-FOLFOXIRI (irinotecan 150 mg/m2, oxaliplatin 85 mg/m2, leucovorin 200 mg/m2, and fluorouracil 2400 mg/m2 as a 46-h continuous infusion) every 14 days as neoadjuvant chemotherapy regimen. This study treatment will continue until surgery, disease progression, unacceptable toxicity, or patient refusal.

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A multicenter randomized phase II/III trial of preoperative versus postoperative chemotherapy with XELOX plus bevacizumab in patients with resectable colorectal liver metastasis.

Project description:Interventions: A: Within 56 days after surgery, patients receive infusional oxaliplatin and oral capecitabine. Patients receive infusional bevacizumab as from second course. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. B: Patients receive infusional oxaliplatin, bevacizumab and oral capecitabine. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients do not receive bevacizumab at last course. Within 56 days after chemotherapy, patients receive surgery. Primary outcome(s): Treatment compliance (phase II) Progression-free survival (phase III) Study Design: Parallel Randomized

| 2619239 | ecrin-mdr-crc

A prospective study of investigating the efficacy of FOLFIRI plus Aflibercept as a 2nd line therapy after progression during FOLFOXIRI plus Bevacizumab in unrescetable / metastatic colorectal cancer (CRC) patients.

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A Study of Trifluridine/Tipiracil (Also Known as S 95005 or TAS-102) in Patients With a Pretreated Colorectal Cancer That Has Spread (Metastatic).

Project description:The purpose of this study is to collect additional safety and efficacy data during treatment with trifluridine / tipiracil in patients with a pretreated metastatic colorectal cancer (mCRC). Eligible patients may receive an early access to trifluridine / tipiracil through this clinical study until progression of disease, unacceptable toxicity, investigator decision, patient refusal or until market authorization or reimbursement has been granted by the relevant Authority of the country where that patient is treated or until trifluridine / tipiracil is available by a doctor’s prescription or can be accessed from another source or Sponsor decision.

| 2256144 | ecrin-mdr-crc

Efficacy of Neoadjuvant Chemotherapy DOX and XELOX Regimens for Patients with Resectable Gastric or Gastroesophageal Junction Adenocarcinoma.

Project description:PurposeThis paper is aimed at comparing the short-term efficacy of the combination of docetaxel, oxaliplatin, and capecitabine (DOX) with the combination of oxaliplatin and capecitabine (XELOX) as neoadjuvant chemotherapy regimens for the treatment of patients with resectable gastric or gastroesophageal junction adenocarcinoma.MethodsA total of 300 patients aged 20-60 years with resectable gastric or gastroesophageal junction adenocarcinoma who were evaluated with cT3/4Nany were randomly assigned into 3 groups: DOX group (n = 100, treated with neoadjuvant DOX plus adjuvant XELOX), XELOX group (n = 100, treated with perioperative XELOX), and surgery group (n = 100, treated with adjuvant XELOX).ResultsA total of 93, 92, and 95 patients were enrolled in the DOX, XELOX, and surgery groups, respectively. The pathological complete response (pCR) rate was 16.1% in the DOX group and 4.3% in the XELOX group (P = 0.008). There were 56 (61.3%) patients in the DOX group who presented with surgical complications, 22 (23.9%) patients in the XELOX group, and 37 (38.9%) patients in the surgery group. The most common grade 3-4 adverse events in these three groups were neutropenia (32.3%, 30.4%, and 21.1%), leucopenia (21.5%, 22.8%, and 15.8%), nausea (15.1%, 16.3%, and 12.6%), and fatigue (10.8%, 7.6%, and 8.4%).ConclusionsNeoadjuvant DOX is an effective and feasible regimen and might represent an option for young and middle-aged patients with locally advanced, resectable gastric or gastroesophageal junction adenocarcinoma.

| S-EPMC8324337 | biostudies-literature

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