Laparoscopic Surgery VS Laparoscopic Surgery + Neoadjuvant Chemotherapy for T4 Tumor of the Colon Cancer

Study Overview
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Brief Summary
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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 Laparoscopic surgery for T4 colon cancers Neoadjuvantive chemotherapy + Laparoscopic surgery for T4 colon cancers

Detailed Description
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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.

Official Title
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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

Conditions
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Colonic Neoplasms

Intervention / Treatment
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* Drug: XELOX or FOLFOX chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to provide written informed consent Histologically confirmed diagnosis of colon carcinoma CT or MRI verified as T4 colon cancer without involvement of other organs. Without multiple lesions other than carcinoma in situ Tumor size < 8 cm No bowel obstruction Sufficient organ function No history of gastrointestinal surgery 18 years of age or older Performance Status (ECOG) 0, 1 or 2, life expectancy > 12 weeks Operable patients Completion of neoadjuvant systemic chemotherapy Exclusion Criteria: Women who are pregnant (confirmed by serum b-HCG in women of reproductive age) or breast feeding No intention to finish neoadjuvantive systemic therapy Unstable or uncompensated respiratory or cardiac disease Serious active infections Hypersensitivity to capecitabine/fluorouracil or oxaliplatin Stomatitis or ulceration in the mouth or gastrointestinal tract Severe diarrhea Peripheral sensory neuropathy with functional impairment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Laparoscopic surgery<br>Patients with T4 colon cancer receive laparoscopic surgery only. | |
| Experimental: Neoadjuvantive chemotherapy + Laparoscopic surgery<br>Patients with T4 colon cancer receive neoadjuvantive chemotherapy and laparoscopic surgery. | Drug: XELOX or FOLFOX chemotherapy<br>* 4 cycles of XELOX or FOLFOX neoadjuvant chemotherapy before surgery<br>* Other names: Xeloda+ OXA or OXA+ 5-FU;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival | calculated from the date of surgery to the date of recurrence | 3-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | calculated from the date of diagnosis to the date of death from any cause | 3-year | 
| Adverse events (mortality and morbidity) | Number of participants with treatment-related adverse events assessed by CTCAE v4.0 | 3-month | 
| The proportion of completion of laparoscopic surgery | The number of completion of laparoscopic surgery/the number of participants | 1-month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonic Neoplasms, Laparoscopic Surgery, Neoadjuvant chemotherapy, T4