Laparoscopic Surgery VS Laparoscopic Surgery + Neoadjuvant Chemotherapy for T4 Tumor of the Colon Cancer
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|ClinicalTrials.gov Identifier: NCT02777437|
Recruitment Status : Not yet recruiting
First Posted : May 19, 2016
Last Update Posted : May 19, 2016
Primary Outcome Measures: Disease free survival
Secondary Outcome Measures:
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
- Laparoscopic surgery for T4 colon cancers
- Neoadjuvantive chemotherapy + Laparoscopic surgery for T4 colon cancers
|Condition or disease||Intervention/treatment||Phase|
|Colonic Neoplasms||Drug: XELOX or FOLFOX chemotherapy||Phase 2 Phase 3|
Investigators' previous studies indicated that laparoscopic surgery is feasible in T4 colon cancers with comparable clinical and oncologic outcomes. Laparoscopy may be considered as an alternative approach for T4 colon cancers with the advantage of faster recovery. The survival outcome of T4 colon cancers still dismays clinicians and patients. Preoperative chemotherapy is an attractive concept for locally advanced colon cancer. Optimal systemic therapy at the earliest possible opportunity may be more effective at eradicating distant metastases than the same treatment given after the delay and immunological stress of surgery. Besides, the shrinkage of primary tumor before surgery may reduce the risk of incomplete surgical excision and the risk of shedding of tumor cells during surgery. The aim of the present study is to compare the short-and long-term survival outcomes between laparoscopic surgery alone and laparoscopic surgery with 4 cycles of neoadjuvant chemotherapy for T4 colon cancer as well as the mortality and the morbidity.
The number of patients, which needs to get power of 80%, is 1960. The average numbers of patients needs to reach approximately 200, and that of surgical centers needs to reach 10.
Arrangements in the preoperative, intraoperative and postoperative period will be in complete accordance with the usual care of the center.
The baseline demographics and conditions as well as the perioperative items and the postoperative occurrences will be recorded through a prior designed e-questionnaire.
Globally,the disease free survival rate (chemotherapy and surgery), mortality (chemotherapy and surgery), the morbidity (chemotherapy and surgery) and the proportion of completion of laparoscopic surgery of the two surgical strategies will be analized and compared.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1960 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Laparoscopic Surgery VS Laparoscopic Surgery + Neoadjuvant Chemotherapy for T4 Tumor of the Colon Cancer: A Prospective, Multi-Center, Randomized, Open-Label, Parallel Group Clinical Trial|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2021|
No Intervention: Laparoscopic surgery
Patients with T4 colon cancer receive laparoscopic surgery only.
Experimental: Neoadjuvantive chemotherapy + Laparoscopic surgery
Patients with T4 colon cancer receive neoadjuvantive chemotherapy and laparoscopic surgery.
Drug: XELOX or FOLFOX chemotherapy
4 cycles of XELOX or FOLFOX neoadjuvant chemotherapy before surgery
Other Name: Xeloda+ OXA or OXA+ 5-FU
- Disease free survival [ Time Frame: 3-year ]calculated from the date of surgery to the date of recurrence
- Overall survival [ Time Frame: 3-year ]calculated from the date of diagnosis to the date of death from any cause
- Adverse events (mortality and morbidity) [ Time Frame: 3-month ]Number of participants with treatment-related adverse events assessed by CTCAE v4.0
- The proportion of completion of laparoscopic surgery [ Time Frame: 1-month ]The number of completion of laparoscopic surgery/the number of participants
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02777437
|Contact: Jiong Wu, MD,PhDemail@example.com|
|Contact: Wei Jin, MD,PhD||0086-21-64175590 ext firstname.lastname@example.org|
|Principal Investigator:||Xinxiang Li, MD,PhD||Fudan University|