Laparoscopic Surgery VS Laparoscopic Surgery + Neoadjuvant Chemotherapy for T4 Tumor of the Colon Cancer

• Status: Unknown status
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary Outcome Measures: Disease free survival

Secondary Outcome Measures:

Overall survival

Adverse events (Mortality, morbidity)

The proportion of completion of Laparoscopic Surgery

Estimated Enrollment: Oct, 2016

Study Start Date: Oct, 2016

Estimated Study Completion Date: Oct, 2019

Estimated Primary Completion Date: Oct, 2021

Groups/Cohorts

1. Laparoscopic surgery for T4 colon cancers

2. Neoadjuvantive chemotherapy + Laparoscopic surgery for T4 colon cancers

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Collaborators: Shanghai Jiao Tong University School of Medicine; Tongji University; Zhejiang University

Criteria

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 lesions 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, life expectancy > 12 weeks

• Operable patients

• Completion of neoadjuvant systemic chemotherapy

Exclusion Criteria:

• Women who are pregnant (confirmed by serum b-HCG in women of reproductive age) or breast feeding

• No intention to finish neoadjuvantive systemic therapy

• Unstable or uncompensated respiratory or cardiac disease

• Serious active infections

• Hypersensitivity to capecitabine/fluorouracil or oxaliplatin

• Stomatitis or ulceration in the mouth or gastrointestinal tract

• Severe diarrhea

• Peripheral sensory neuropathy with functional impairment