Laparoscopic Surgery for T4 Tumor of the Colon Cancer (LST4C Trial)
1 other identifier
interventional
957
1 country
1
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 not_applicable
Started Oct 2016
Longer than P75 for not_applicable
1 active site
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
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 16, 2017
CompletedFirst Posted
Study publicly available on registry
October 19, 2017
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
CompletedNovember 6, 2018
November 1, 2018
3 years
October 16, 2017
November 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
calculated from the date of diagnosis to the date of death from any cause
3-year
Secondary Outcomes (2)
Disease free survival
3-year
Adverse events (mortality and morbidity)
3-month
Study Arms (2)
Laparoscopic surgery for T4 colon tumor
EXPERIMENTALLaparoscopic surgery for T4 colon cancers
Open surgery for T4 colon tumor
NO INTERVENTIONConventional open surgery for T4 colon cancers
Interventions
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
Study Sites (1)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
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
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 16, 2017
First Posted
October 19, 2017
Study Start
October 1, 2016
Primary Completion
October 1, 2019
Study Completion
October 1, 2024
Last Updated
November 6, 2018
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share