Phase II randomised study of maintenance treatment with bevacizumab or bevacizumab plus metronomic chemotherapy after first-line induction with FOLFOXIRI plus Bevacizumab for metastatic colorectal cancer patients: the MOMA trial

et al. 2020

Trials

A study of capecitabine metronomic chemotherapy is non-inferior to conventional chemotherapy as maintenance strategy in responders after induction therapy in metastatic colorectal cancer Abstract Background: The aim of this study is to demonstrate that capecitabine metronomic chemotherapy is non-inferior to capecitabine conventional chemotherapy as maintenance treatment, in patients who have responded to 16-18 weeks first-line chemotherapy in metastatic colorectal cancer (mCRC). Methods:The study design is a prospective, randomized, open label, phase II clinical trial. Those patients with mCRC who respond well after 16-18 weeks of standard doublet chemotherapy as induction may be enrolled into this study, and randomly assigned to the capecitabine metronomic group or standard dosage group. The duration of disease control after randomization and progression-free survival after enrollment are the primary endpoints. Overall survival, safety, and quality of life are the secondary endpoints. The sample size required to achieve the research objectives of this project is 79 patients in each group. The study recently started on 1 January 2018, and will last for 36 months.Discussion: This project is intended to study the efficacy and safety of capecitabine metronomic chemotherapy in the maintenance treatment of advanced colorectal cancer, and to explore the strategy of "low toxicity, high efficiency, economy, and individualization", which is suitable for China's national conditions and pharmacoeconomics. It has great prospects for clinical application and a clear socioeconomic value.

Section: Discussionmentioning

confidence: 99%

A study of capecitabine metronomic chemotherapy is non-inferior to conventional chemotherapy as maintenance strategy in responders after induction therapy in metastatic colorectal cancer

et al. 2020

Trials

“…The limitations are mainly due to severe neurotoxicity (oxaliplatin) and chronic diarrhea (irinotecan) [20]. Thus, limiting the duration of the induction chemotherapy to a short period, then exploiting maintenance to prolong disease control at the price of a reasonable toxicity profile, is an appealing strategy for mCRC patients [21].…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Capecitabine Metronomic Chemotherapy versus Conventional Chemotherapy as Maintenance Strategy in Responders After Induction Therapy in Metastatic Colorectal Cancer

et al. 2020

Preprint

Background: The aim of this study is to demonstrate that capecitabine metronomic chemotherapy is non-inferior to capecitabine conventional chemotherapy as maintenance treatment, who have responded to 16-18 weeks first-line chemotherapy in metastatic colorectal cancer (mCRC). Methods: The study design is a prospective, randomized, open label, phase II clinical trial. Those mCRC patients who respond well after 16-18 weeks of standard doublet chemotherapy as induction may enrolled into this study, randomly divided into capecitabine metronomic group or standard dosage group. The duration of disease control after randomization and progression free survival from enrollment are primary endpoints. Meanwhile, the overall survival, safety and quality of life are secondary endpoints. The sample size required to achieve the research objectives of this project is 79 cases in each group. The study recently started on 29-01-2018, and will last for 36 months. Discussion: This project intends to study the efficacy and safety of capecitabine metronomic chemotherapy in the maintenance treatment of advanced colorectal cancer, and to explore the strategy of "low toxicity, high efficiency, economy and individualization" which is suitable for China's national conditions and pharmacoeconomics. It has great clinical application prospects and clear socio-economic value.

“…Until recently, few mCRC patients could tolerate full doses of chemotherapy longer than 4-6 months, The limitations are mainly due to severe neurotoxicity (oxaliplatin) and chronic diarrhea (irinotecan) [18]. Thus, limiting the duration of the induction chemotherapy to a short period, then exploiting maintenance to prolong disease control at the price of a reasonable toxicity profile, is an appealing strategy for mCRC patients [19].…”

Section: Discussionmentioning

confidence: 99%

Biological-guided Metronomic Chemotherapy as Maintenance Strategy in Responders After Induction Therapy in Metastatic Colorectal Cancer

et al. 2019

Preprint

Background The aim of this study is to demonstrate that capecitabine metronomic chemotherapy is non-inferior to capecitabine conventional chemotherapy as maintenance treatment, who have responded to 16-18 weeks first-line chemotherapy in metastatic colorectal cancer.Methods The study design is a prospective, randomized, open label, phase II clinical trial. Those mCRC patients who respond well after 16-18 weeks of standard doublet chemotherapy as induction may enrolled into this study, randomly divided into capecitabine metronomic group or standard dosage group. The duration of disease control after randomization and progression free survival from enrollment are primary endpoints. Meanwhile, the overall survival, safety and quality of life are secondary endpoints. The sample size required to achieve the research objectives of this project is 79 cases in each group. The study recently started on 29-01-2018, and will last for 36 months.Discussion This project intends to study the efficacy and safety of capecitabine metronomic chemotherapy in the maintenance treatment of advanced colorectal cancer, and to explore the strategy of "low toxicity, high efficiency, economy and individualization" which is suitable for China's national conditions and pharmacoeconomics. It has great clinical application prospects and clear socio-economic value.