Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
1960 participants
INTERVENTIONAL
2016-10-31
2024-10-31
Brief Summary
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Detailed Description
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The number of patients needed to get a 80% power is 1960. The average number of patients/surgical center is approximately 200 in each of 10 surgical centers.
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.
Systematically analyze and compare the disease free survival rate, the mortality, the morbidity, and the proportion of completion of laparoscopic surgery of the two surgical strategies (laparoscopy VS conventional open surgery).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Laparoscopic surgery for T4 colon cancers
Laparoscopic surgery for T4 colon cancers
Laparoscopic surgery
Laparoscopic surgery for T4 cancer
Conventional open surgery for T4 colon cancers
Conventional open surgery for T4 colon cancers
No interventions assigned to this group
Interventions
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Laparoscopic surgery
Laparoscopic surgery for T4 cancer
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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LI XIN-XIANG
OTHER
Responsible Party
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LI XIN-XIANG
Professor
Principal Investigators
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Xinxiang Li, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Central Contacts
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Other Identifiers
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LapT4
Identifier Type: -
Identifier Source: org_study_id
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