Laparoscopic Surgery for T4 Tumor of the Colon Cancer (NCT02852915) | Clinical Trial Compass
UnknownPhase 3
Laparoscopic Surgery for T4 Tumor of the Colon Cancer
1,960 participantsStarted 2016-10
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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 Criteria:
* 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