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Phase II trial as new chemotherapy regimen for bevacizumab (Bev) in combination with XELOX in unresectable colorectal cancer.

ABSTRACT: Interventions: XELOX+BV 5-days on/ 2-days off Schedule Primary outcome(s): Progression free survival. Study Design: Single arm Non-randomized

DISEASE(S): Unresectable Colorectal Cancer

PROVIDER: 2625551 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Several randomized trials have indicated that combination chemotherapy applied in metastatic colorectal cancer (mCRC) does not significantly improve overall survival when compared to the sequential use of cytotoxic agents (CAIRO, MRC Focus, FFCD 2000-05). The present study investigates the question whether this statement holds true also for bevacizumab-based first-line treatment including escalation- and de-escalation strategies.The AIO KRK 0110/ML22011 trial is a two-arm, multicenter, open-label randomized phase III trial comparing the efficacy and safety of capecitabine plus bevacizumab (Cape-Bev) versus capecitabine plus irinotecan plus bevacizumab (CAPIRI-Bev) in the first-line treatment of metastatic colorectal cancer. Patients with unresectable metastatic colorectal cancer, Eastern Cooperative Oncology Group (ECOG) performance status 0-1, will be assigned in a 1:1 ratio to receive either capecitabine 1250 mg/m(2) bid for 14d (d1-14) plus bevacizumab 7.5 mg/kg (d1) q3w (Arm A) or capecitabine 800 mg/m(2) BID for 14d (d1-14), irinotecan 200 mg/m(2) (d1) and bevacizumab 7.5 mg/kg (d1) q3w (Arm B). Patients included into this trial are required to consent to the analysis of tumour tissue and blood for translational investigations. In Arm A, treatment escalation from Cape-Bev to CAPIRI-Bev is recommended in case of progressive disease (PD). In Arm B, de-escalation from CAPIRI-Bev to Cape-Bev is possible after 6 months of treatment or in case of irinotecan-associated toxicity. Re-escalation to CAPIRI-Bev after PD is possible. The primary endpoint is time to failure of strategy (TFS). Secondary endpoints are overall response rate (ORR), overall survival, progression-free survival, safety and quality of life.The AIO KRK 0110 trial is designed for patients with disseminated, but asymptomatic mCRC who are not potential candidates for surgical resection of metastasis. Two bevacizumab-based strategies are compared: one starting as single-agent chemotherapy (Cape-Bev) allowing escalation to CAPIRI-Bev and another starting with combination chemotherapy (CAPIRI-Bev) and allowing de-escalation to Cape-Bev and subsequent re-escalation if necessary.ClinicalTrials.gov Identifier NCT01249638 EudraCT-No.: 2009-013099-38.

Project description:BACKGROUND: RANO criteria were applied to evaluate differences in response between the 2 arms: TMZ or TMZ + BEV in a randomized study. We evaluate here the RANO sub-criterion (PI) to evaluate response. METHODS: Between December 2009 and April 2013, p with unresectable GBM, PS < 3 and MMS ?25 were randomly assigned to receive eitherTMZ (200 mg/m2, days 1–5,for 2 28-day cycles), followed by standard TMZ with concomitant radiotherapy (60Gy) and then adjuvant TMZ for 6 cycles (TMZ Arm), or the same regimen but with the addition of BEV (10mg/kg /15 days) during pre-radiotherapy and concomitant treatment (BEV Arm). The primary endpoint was response according to RANO criteria after the 2 pre-radiotherapy cycles. The study was powered to detect a 30% difference between arms. A centralized revision of MRI's blinded to clinical status of p is ongoing. (ClinicalTrials.gov NCT01102595). RESULTS:103 p were registered and 93 randomized – 45 to the TMZ Arm and 48 to the BEV Arm. All p who received at least one dose of treatment were included in the analysis. Overall response rate (ORR) was evaluated after the 2-pre-radiotherapy cycles. Patients completed pre-radiotherapy treatment in 48.9% (TMZ Arm) vs 66.7% (BEV Arm), p = 0.08. Response was not evaluable in 3p (TMZ arm) and 5p (BEV arm) because of previous toxicity or refuse to continue. ORR by RANO criteria for evaluable p was: Arm TMZ: PR 3 (7.1%) SD 8 (19%) PD 31 (73.8%)., Arm B: PR 11 (25.6%) SD 17 (39.5%) 15 (34.9%) P = 0.001. Response by individual RANO sub criterion (Arm TMZ% vs Arm BEV%).1- MRI IP: PR (8.3 vs 26.2), SD (22.2 vs 42.8), P (69.4 vs 31) (P = 0.003), 2-Neurological status: SD (54.8 vs 79.5), No SD (45.2 vs 20.5) (P = 0.014), 3-Dexametasone dose: stable (60.5 vs 51.2), increase (28.9 vs 4.7), reduction (10.5 vs 44.2) (P < 0.001). CONCLUSION: ORR was significantly higher in the BEV Arm for both for general RANO criteria as for each individual criterion (MRI, clinical stability and dexametasone doses.

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Phase II trial as new chemotherapy regimen for bevacizumab (Bev) in combination with XELOX in unresectable colorectal cancer.

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