Laparoscopic Surgery for T4 Tumor of the Colon Cancer

LI XIN-XIANG

Status and phase

Not yet enrolling

Phase 3

Conditions

Colonic Neoplasms

Treatments

Procedure: Laparoscopic surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT02852915

LapT4

Details and patient eligibility

About

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.

Full 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).

Enrollment

1,960 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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