Status:
UNKNOWN
Laparoscopic Surgery for T4 Tumor of the Colon Cancer (LST4C Trial)
Lead Sponsor:
LI XIN-XIANG
Conditions:
Colonic Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of this study is to compare the short- and long-term survival of laparoscopic surgery and conventional open surgery for T4 colon cancer
Detailed Description
The investigators previous study indicated that laparoscopic surgery is feasible in T4 colon cancers with comparable clinical and oncologic outcomes. Laparoscopy can be considered as an alternative ap...
Eligibility Criteria
Inclusion
- 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 lesion 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 and life expectancy \> 12 weeks
- Operable patients
Exclusion
- • Women who are pregnant (confirmed by serum b-HCG in women of reproductive age) or breast feeding
- Unstable or uncompensated respiratory or cardiac disease
- Serious active infections
- Hypersensitivity to capecitabine/fluorouracil or oxaliplatin
- Stomatitis, ulceration in the mouth or gastrointestinal tract
- Severe diarrhea
- Peripheral sensory neuropathy with functional impairment
Key Trial Info
Start Date :
October 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
957 Patients enrolled
Trial Details
Trial ID
NCT03314896
Start Date
October 1 2016
End Date
October 1 2024
Last Update
November 6 2018
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032