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

Colonic Neoplasms Clinical Trial

Official title:

Laparoscopic Surgery VS Laparoscopic Surgery + Neoadjuvant Chemotherapy 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: NCT02777437
• Other study ID #: FuDanLapT4
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: May 2, 2016
• Last updated: May 17, 2016
• Start date: October 2016
• Est. completion date: October 2021

Study information

• Verified date: May 2016
• Source: Fudan University
• Contact: Jiong Wu, MD,PhD
• Phone: 0086-21-34610367
• Email: 18918298120[@]163.com
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1960
• Est. completion date: October 2021
• 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 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

Study Design

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

Related Conditions & MeSH terms

• Colonic Neoplasms

Intervention

Drug:
• XELOX or FOLFOX chemotherapy
4 cycles of XELOX or FOLFOX neoadjuvant chemotherapy before surgery

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Fudan University	Shanghai Jiao Tong University School of Medicine, Tongji University, Zhejiang University

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
Secondary	The proportion of completion of laparoscopic surgery	The number of completion of laparoscopic surgery/the number of participants	1-month	No