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Preventive effect of shakuyaku-kanzo-to on neurotoxicity of FOLFOX plus bevacizumab for patients with metastatic colorectal cancer: a prospective phase II study

ABSTRACT: Interventions: Patients receive FOLFOX4 plus bevacizumab or modified FOLFOX6 plus bevacizumab and take shakuyaku-kanzo-to (7.5g/day) orally every day during FOLFOX plus bevacizumab treatment. Primary outcome(s): Neurotoxicity frequency of accumulation dose 500mg/m2 of oxaliplatin Study Design: Single arm Non-randomized

DISEASE(S): Colorectal Cancer

PROVIDER: 2617341 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Preventive effect of pregabalin on oxaliplatin-related neurotoxicity for patients with advanced/recurrent colorectal cancer: a prospective phase 2 study

Project description:Interventions: Pregabalin is administered during FOLFOX or XELOX therapy. Initial dose:75mg twice daily(150mg/day),increased to 300 - 600mg/day if there was persistent paresthesia or functional impariment(Grade2 or more). Primary outcome(s): Neurotoxicity frequency of accumulation dose 500mg/m2 of L-OHP (Grade2 or more) Study Design: Single arm Non-randomized

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Preventive Effect of Goshajinkigan on Peripheral Neurotoxicity of FOLFOX Therapy :A Placebo-controlled Double-blind Randomized Phase III Study

Project description:Interventions: Goshajinkigan 7.5g/day, 12 course + mFOLFOX6 12 course Placebo 7.5g/day, 12 course + mFOLFOX6 12 course Primary outcome(s): TimeToGrade2+ (CTCAE v4.0) Neuropathy; TTN Study Design: Parallel Randomized

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Phase I study of the preventive effect of Kampo medicine on oxaliplatin-induced peripheral neurotoxicity

Project description:Interventions: During XELOX regimen, Kampo medicine is administered as follows: Level 1(TJ-18 7.5g, TJ-3023 0g), Level 2(TJ-18 7.5g, TJ-3023 1.5g), Level 3(TJ-18 7.5g, TJ-3023 3.0g) Primary outcome(s): Decision of DLT, MTD, RD of Kampo medicine (TJ-3023, TJ-18) Study Design: Single arm Non-randomized

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Prediction of response to FOLFOX

Project description:The patients who underwent surgery for primary lesions were examined. All patients had metastatic or recurrent CRC and received modified FOLFOX6. Responders and nonresponders were determined based on the best observed response at the end of the first-line treatment, mFOLFOX6. Gene-expression profiles of primary CRC were determined using Human Genome GeneChip arrays U133. Colorectal cancer patients who had undergone surgical resection of colorectal cancer were studied. To identify molecular signatures to predict response to mFOLFOX6 regimen, gene expression profiles were compared between Reponder and Non-responder. Some patients are overlapped with Bevacizumab therapy.

2013-01-03 | E-GEOD-19860 | biostudies-arrayexpress

Preventive effect of Goshajinkigan on peripheral neurotoxicity of FOLFOX therapy: A placebo-controlled double blind randomized Phase II study (The GONE Study)

Project description:Interventions: FOLFOX4(L-OHP85mg/m2, l-LV100mg/m2x2, 5FU400mg/m2(bolus)x2, 5FU600mg/m2x2(civ)) or mFOLFOX6(L-OHP85mg/m2, l-LV200mg/m2, 5FU400mg/m2(bolus), 5FU240mg/m2(civ)).Cycles of chemotherapy are given every 2 weeks until PD or unacceptable toxicity occurred. Goshajinkigan(GJG) is given orally at a dose of 2.5 g three times a day for 26 weeks starting on the day of L-OHP infusion. FOLFOX4(L-OHP85mg/m2, l-LV100mg/m2x2, 5FU400mg/m2(bolus)x2, 5FU600mg/m2x2(civ)) or mFOLFOX6(L-OHP85mg/m2, l-LV200mg/m2, 5FU400mg/m2(bolus), 5FU240mg/m2(civ)).Cycles of chemotherapy are given every 2 weeks until PD or unacceptable toxicity occurred. Placebo is given orally at a dose of 2.5 g three times a day for 26 weeks starting on the day of L-OHP infusion. Primary outcome(s): The incidence of peripheral neurotoxicity ≥grade 2 after eight cycles of chemotherapy. Study Design: Parallel Randomized

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Immuno-priming with bevacizumab: durvalumab plus bevacizumab after prolonged exposition to bevacizumab in breast cancer

Project description:Immuno-priming with bevacizumab: durvalumab plus bevacizumab after prolonged exposition to bevacizumab in breast cancer

| PRJNA578152 | ENA

Small RNA-seq of breast tumor biopsies prior to treatment with letrozole or letrozole with bevacizumab

Project description:Biopsies were collected from post-menopausal women with ER+ HER2- breast cancer who were subsequently treated with either letrozole or letrozole plus bevacizumab.

2019-12-19 | GSE142308 | GEO

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

TAS-102, Irinotecan, and Bevacizumab in Pre-treated Metastatic Colorectal Cancer (TABAsCO), A Phase II Clinical Trial. ClinicalTrials.gov NCT04109924

Project description:Background: The efficacy of FOLFIRI plus an antiangiogenesis biologic agent as 2nd line therapy for metastatic colorectal adenocarcinoma is limited. TAS-102 is a novel oral antimetabolite with a distinct mechanism of action from fluoropyrimidines. We evaluated the antitumor efficacy of TAS-102, irinotecan and bevacizumab in patients with pre-treated, advanced colorectal adenocarcinoma in a multicenter, phase II, single-arm study. Methods: Patients with advanced colorectal adenocarcinoma who had progressed after oxaliplatin and fluoropyrimidine and were eligible for treatment with bevacizumab were treated with irinotecan, bevacizumab, and TAS-102 in 28-day cycles. The primary endpoint was progression-free survival (PFS). Results: We enrolled 35 evaluable patients. The study was positive. The median PFS was 7.9 (90% CI 6.2-11.8) months (vs. 6 months in historical control, p=0.018). The median overall survival was 16.5 (90% CI 9.8-17.5) months. Sixty-seven percent of patients experienced grade 3 or higher treatment-related adverse events. The most common toxicities were hematological (neutropenia) and gastrointestinal (diarrhea, nausea, and vomiting). Conclusions: Irinotecan, TAS-102 and bevacizumab is an active 2nd line therapy for patients with metastatic colorectal adenocarcinoma. Neutropenia is common and can affect dose density/intensity mandating use of G-CSF. A randomized study versus standard of care therapy is warranted.

2024-08-26 | GSE275628 | GEO

Preventive effect and safety of pregabalin on FOLFOX-related peripheral neurotoxicity for patients with advanced and recurrent colorectal cancer

Project description:Interventions: In case of FOLFOX related-peripheral neurotoxicity (Grade1), pregabalin is administered. Primary outcome(s): Neurotoxicity frequency of cumulative dose 500mg/m2 of oxaliplatin (Grade2 and more) Study Design: Single arm Non-randomized

| 2628289 | ecrin-mdr-crc

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