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

NCT ID: NCT02777437

Last Updated: 2016-05-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 1960 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2021-10-31

Brief 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

Detailed Description

Investigators' previous studies indicated that laparoscopic surgery is feasible in T4 colon cancers with comparable clinical and oncologic outcomes. Laparoscopy may be considered as an alternative approach for T4 colon cancers with the advantage of faster recovery. The survival outcome of T4 colon cancers still dismays clinicians and patients. Preoperative chemotherapy is an attractive concept for locally advanced colon cancer. Optimal systemic therapy at the earliest possible opportunity may be more effective at eradicating distant metastases than the same treatment given after the delay and immunological stress of surgery. Besides, the shrinkage of primary tumor before surgery may reduce the risk of incomplete surgical excision and the risk of shedding of tumor cells during surgery. The aim of the present study is to compare the short-and long-term survival outcomes between laparoscopic surgery alone and laparoscopic surgery with 4 cycles of neoadjuvant chemotherapy for T4 colon cancer as well as the mortality and the morbidity.

The number of patients, which needs to get power of 80%, is 1960. The average numbers of patients needs to reach approximately 200, and that of surgical centers needs to reach 10.

Arrangements in 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.

Globally,the disease free survival rate (chemotherapy and surgery), mortality (chemotherapy and surgery), the morbidity (chemotherapy and surgery) and the proportion of completion of laparoscopic surgery of the two surgical strategies will be analized and compared.

Conditions

Colonic Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laparoscopic surgery

Patients with T4 colon cancer receive laparoscopic surgery only.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Neoadjuvantive chemotherapy + Laparoscopic surgery

Patients with T4 colon cancer receive neoadjuvantive chemotherapy and laparoscopic surgery.

Group Type: EXPERIMENTAL

XELOX or FOLFOX chemotherapy

Intervention Type: DRUG

4 cycles of XELOX or FOLFOX neoadjuvant chemotherapy before surgery

Interventions

XELOX or FOLFOX chemotherapy

4 cycles of XELOX or FOLFOX neoadjuvant chemotherapy before surgery

Intervention Type: DRUG

Other Intervention Names

Xeloda+ OXA or OXA+ 5-FU

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: collaborator

Zhejiang University

OTHER

Sponsor Role: collaborator

Tongji University

OTHER

Sponsor Role: collaborator

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

LI XIN-XIANG

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xinxiang Li, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Central Contacts

Jiong Wu, MD,PhD

Role: CONTACT

18918298120@163.com

0086-21-34610367

Wei Jin, MD,PhD

Role: CONTACT

34865893@qq.com

0086-21-64175590 ext. 25022

Other Identifiers

FuDanLapT4

Identifier Type: -

Identifier Source: org_study_id