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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02852915
Other study ID # LapT4
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received July 21, 2016
Last updated August 3, 2016
Start date October 2016
Est. completion date October 2024

Study information

Verified date August 2016
Source Fudan University
Contact Xinxiang Li, MD,PhD
Phone 86-13918176716
Email lxx1149@163.com
Is FDA regulated No
Health authority China: Shanghai Municipal Commission of Health Planning
Study type Interventional

Clinical Trial 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.


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 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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1960
Est. completion date October 2024
Est. primary completion date October 2019
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Laparoscopic surgery
Laparoscopic surgery for T4 cancer

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
LI XIN-XIANG

Outcome

Type Measure Description Time frame Safety issue
Primary Disease free survival calculated from the date of surgery to the date of recurrence 3-year No
Secondary Overall survival calculated from the date of diagnosis to the date of death from any cause 3-year No
Secondary Adverse events (mortality and morbidity) Number of participants with treatment-related adverse events assessed by CTCAE v4.0 3-month Yes
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