Laparoscopic Surgery for T4 Tumor of the Colon Cancer

Colonic Neoplasms Clinical Trial

Official title:

Laparoscopic Surgery for T4 Tumor of the Colon Cancer: A Prospective, Multi-Center, Randomized, Open-Label, Parallel Group Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02852915
• Other study ID #: LapT4
• 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

• Colonic Neoplasms

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