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

May 17, 2016 updated by: LI XIN-XIANG, Fudan University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

1960

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Wei Jin, MD,PhD
  • Phone Number: 25022 0086-21-64175590
  • Email: 34865893@qq.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Laparoscopic surgery
Patients with T4 colon cancer receive laparoscopic surgery only.
Experimental: Neoadjuvantive chemotherapy + Laparoscopic surgery
Patients with T4 colon cancer receive neoadjuvantive chemotherapy and laparoscopic surgery.
Drug: XELOX or FOLFOX chemotherapy
4 cycles of XELOX or FOLFOX neoadjuvant chemotherapy before surgery
Other Names:
  • Xeloda+ OXA or OXA+ 5-FU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease free survival
Time Frame: 3-year
calculated from the date of surgery to the date of recurrence
3-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 3-year
calculated from the date of diagnosis to the date of death from any cause
3-year
Adverse events (mortality and morbidity)
Time Frame: 3-month
Number of participants with treatment-related adverse events assessed by CTCAE v4.0
3-month
The proportion of completion of laparoscopic surgery
Time Frame: 1-month
The number of completion of laparoscopic surgery/the number of participants
1-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Collaborators

Shanghai Jiao Tong University School of Medicine
Tongji University
Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

May 2, 2016

First Submitted That Met QC Criteria

May 17, 2016

First Posted (Estimate)

May 19, 2016

Study Record Updates

Last Update Posted (Estimate)

May 19, 2016

Last Update Submitted That Met QC Criteria

May 17, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FuDanLapT4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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