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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03792269
|Contact: Jing Hu, M.D., P.hDemail@example.com|
|Contact: Xiaoping Qian, M.D., P.hDfirstname.lastname@example.org|
|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|