Laparoscopic Surgery for T4 Tumor of the Colon Cancer
1 other identifier
interventional
1,960
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2016
Longer than P75 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2016
CompletedFirst Posted
Study publicly available on registry
August 2, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2024
CompletedAugust 4, 2016
August 1, 2016
3 years
July 21, 2016
August 3, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease free survival
calculated from the date of surgery to the date of recurrence
3-year
Secondary Outcomes (2)
Overall survival
3-year
Adverse events (mortality and morbidity)
3-month
Study Arms (2)
Laparoscopic surgery for T4 colon cancers
EXPERIMENTALLaparoscopic surgery for T4 colon cancers
Conventional open surgery for T4 colon cancers
NO INTERVENTIONConventional open surgery for T4 colon cancers
Interventions
Laparoscopic surgery for T4 cancer
Eligibility Criteria
You may qualify if:
- 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
- years of age or older
- Performance Status (ECOG) 0, 1 or 2 and life expectancy \> 12 weeks
- Operable patients
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LI XIN-XIANGlead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xinxiang Li, MD,PhD
Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 21, 2016
First Posted
August 2, 2016
Study Start
October 1, 2016
Primary Completion
October 1, 2019
Study Completion
October 1, 2024
Last Updated
August 4, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share