Laparoscopic Surgery VS Laparoscopic Surgery + Neoadjuvant Chemotherapy for T4 Tumor of the Colon Cancer
NCT02777437 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1960
Last updated 2016-05-19
Summary
Primary Outcome Measures: Disease free survival
Secondary Outcome Measures:
Overall survival
Adverse events (Mortality, morbidity)
The proportion of completion of Laparoscopic Surgery
Estimated Enrollment: Oct, 2016
Study Start Date: Oct, 2016
Estimated Study Completion Date: Oct, 2019
Estimated Primary Completion Date: Oct, 2021
Groups/Cohorts
1. Laparoscopic surgery for T4 colon cancers
2. Neoadjuvantive chemotherapy + Laparoscopic surgery for T4 colon cancers
Conditions
- Colonic Neoplasms
Interventions
- DRUG
-
XELOX or FOLFOX chemotherapy
4 cycles of XELOX or FOLFOX neoadjuvant chemotherapy before surgery
Sponsors & Collaborators
-
Shanghai Jiao Tong University School of Medicine
collaborator OTHER -
Zhejiang University
collaborator OTHER -
Tongji University
collaborator OTHER -
Fudan University
lead OTHER
Principal Investigators
-
Xinxiang Li, MD,PhD · Fudan University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-10-31
- Primary Completion
- 2019-10-31
- Completion
- 2021-10-31
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