Intraperitoneal and System Chemotherapy Versus XELOX as First-line Chemotherapy for mCRC
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|ClinicalTrials.gov Identifier: NCT03792269|
Recruitment Status : Recruiting
First Posted : January 3, 2019
Last Update Posted : January 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Metastatic Chemotherapy Effect Chemotherapeutic Toxicity||Drug: Irinotecan Drug: Oxaliplatin Drug: Capecitabine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||An Open-label, Randomized, Phase II Clinical Trial Comparing the Efficacy and Safety of Intraperitoneal and System Chemotherapy Versus XELOX as First-line Chemotherapy for Metastatic Colorectal Cancer|
|Actual Study Start Date :||January 1, 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2020|
Experimental: Multi-channel chemotherapy
Patients will receive intraperitoneal irinotecan (50mg, d1, q2w).
Active Comparator: Control Group
Patients will receive intravenous oxaliplatin (130mg/m^2, d1, q3w), and oral capecitabine (1.0g, d1-14, q3w).
Other Name: Oral
- Progression-free Survival (PFS) [ Time Frame: up to 1 year ]PFS is the period between the first course of treatment to disease recurrence. The follow-up work will be performed every 6 weeks until disease recurrence or loss to follow-up.
- Overall Survival (OS) [ Time Frame: up to 2 years ]OS is the period between the first course of treatment to death. The follow-up work will be performed every 3 months until death or loss to follow-up.
- Objective Response Rate (ORR) [ Time Frame: up to 24 weeks ]CT/MRI will be performed every 2 cycles of treatment for short-term efficacy. evaluation
- Adverse Events (AE) [ Time Frame: up to 2 years ]Adverse effects will be recorded during the whole treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03792269
|Contact: Jing Hu, M.D., P.hDfirstname.lastname@example.org|
|Contact: Xiaoping Qian, M.D., P.hDemail@example.com|
|The Comprehensive Cancer Center of Nanjing Drum Tower Hospital||Recruiting|
|Nanjing, Jiangsu, China, 210008|
|Contact: Jing Hu, M.D., P.hD|
|Study Chair:||Jing Jing||The Comprehensive Cancer Center of Nanjing Drum Tower Hospital|