Clinical trial NCT02777437: Laparoscopic Surgery VS Laparoscopic Surgery + Neoadjuvant Chemotherapy for T4 Tumor of the Colon Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Colonic Neoplasms
Keywords: Colonic Neoplasms
Laparoscopic Surgery
Neoadjuvant chemotherapy
T4
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Shanghai Jiao Tong University School of Medicine
name: Zhejiang University
name: Tongji University
First posted: 2016-05-19
Enrollment: 1960
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Disease free survival
timeFrame: 3-year
Secondary outcomes:
measure: Overall survival
timeFrame: 3-year
measure: Adverse events (mortality and morbidity)
timeFrame: 3-month
measure: The proportion of completion of laparoscopic surgery
timeFrame: 1-month
Other outcomes:
Locations:
Study officials:
affiliation: Fudan University
name: Xinxiang Li, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: