Laparoscopic Surgery for T4 Tumor of the Colon Cancer | NCT02852915

Studies
Laparoscopic Surgery for T4 Tumor of the Colon Cancer

NCT02852915

Sponsor

LI XIN-XIANG

Status

Unknown status

Last Update Posted

Aug 4, 2016Estimated

Enrollment

1,960Estimated

Phase

Phase 3

Conditions

Colonic Neoplasms

Interventions

Laparoscopic surgery

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016

Primary Completion Date

Oct 2019Estimated

Completion Date

Oct 2024Estimated

First Submitted Date

Jul 21, 2016

First Submission Date that Met QC Criteria

Jul 28, 2016

First Posted Date

Aug 2, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 3, 2016

Last Update Posted Date

Aug 4, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to compare the short- and long-term survival of laparoscopic surgery and conventional open surgery for T4 colon cancer.

Detailed Description

The investigators previous study indicated that laparoscopic surgery is feasible in T4 colon cancers with comparable clinical and oncologic outcomes. Laparoscopy can be considered as an alternative approach for T4 colon cancers with the advantage of faster recovery. However, the clinical value of laparoscopic surgery for T4 colon cancer was only validated in some retrospective study and some prospective study in single institute with small sample of patients. The aim of the present study is to compare the short-and long-term survival outcomes of laparoscopic surgery and conventional open surgery for T4 colon cancer as well as the mortality and the morbidity.

The number of patients needed to get a 80% power is 1960. The average number of patients/surgical center is approximately 200 in each of 10 surgical centers.

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.

Systematically analyze and compare the disease free survival rate, the mortality, the morbidity, and the proportion of completion of laparoscopic surgery of the two surgical strategies (laparoscopy VS conventional open surgery).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,960Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Laparoscopic surgery for T4 colon cancers	Experimental	Laparoscopic surgery for T4 colon cancers	Procedure: Laparoscopic surgery
Conventional open surgery for T4 colon cancers	No Intervention	Conventional open surgery for T4 colon cancers

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laparoscopic surgery	Procedure	Laparoscopic surgery for T4 cancer	Laparoscopic surgery for T4 colon cancers

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Overall survival	calculated from the date of diagnosis to the date of death from any cause	3-year
Adverse events (mortality and morbidity)	Number of participants with treatment-related adverse events assessed by CTCAE v4.0

Other Outcomes

Not provided

Eligibility Module

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 lesion 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 and life expectancy > 12 weeks
Operable patients

Exclusion Criteria:

Women who are pregnant (confirmed by serum b-HCG in women of reproductive age) or breast feeding
Unstable or uncompensated respiratory or cardiac disease
Serious active infections
Hypersensitivity to capecitabine/fluorouracil or oxaliplatin
Stomatitis, ulceration in the mouth or gastrointestinal tract
Severe diarrhea
Peripheral sensory neuropathy with functional impairment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xinxiang Li, MD,PhD	Contact	86-13918176716		lxx1149@163.com
Qingguo Li, MD,PhD	Contact	86-18918298120		13111230016@fudan.edu.cn

Overall Officials

Name	Affiliation	Role
Xinxiang Li, MD,PhD	Fudan University	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003110	Colonic Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010535	Laparoscopy

Ancestor Terms

ID	Term
D004724	Endoscopy
D003949	Diagnostic Techniques, Surgical
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided