- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03314896
Laparoscopic Surgery for T4 Tumor of the Colon Cancer (LST4C Trial)
Laparoscopic Surgery for T4 Tumor of the Colon Cancer: A Prospective, MultiCenter, Randomized, Open-Label, Parallel Group Clinical Trial (LST4C Trial)
Study Overview
Status
Conditions
Intervention / Treatment
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 approach for T4 colon cancers with the advantage of faster recovery. However, the clinical value of laparoscopic surgery for T4 colon cancer was only validated in some retrospective study and some prospective study in single institute with small sample of patients. The aim of the present study is to compare the short-and long-term survival outcomes of laparoscopic surgery and conventional open surgery for T4 colon cancer as well as the mortality and the morbidity. 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 equestionnaire.
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).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200032
- Recruiting
- Fudan University Shanghai Cancer Center
-
Principal Investigator:
- Xinxiang Li, MD,PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Laparoscopic surgery for T4 colon tumor
Laparoscopic surgery for T4 colon cancers
|
Other Names:
|
No Intervention: Open surgery for T4 colon tumor
Conventional open surgery for T4 colon cancers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: 3-year
|
calculated from the date of diagnosis to the date of death from any cause
|
3-year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease free survival
Time Frame: 3-year
|
calculated from the date of surgery to the date of recurrence
|
3-year
|
Adverse events (mortality and morbidity)
Time Frame: 3-month
|
Number of participants with treatment-related adverse events assessed by CTCAE v4.0
|
3-month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LST4C trial
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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