Laparoscopic Surgery VS Laparoscopic Surgery + Neoadjuvant Chemotherapy for T4 Tumor of the Colon Cancer
1 other identifier
interventional
1,960
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2016
Longer than P75 for phase_2
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
May 2, 2016
CompletedFirst Posted
Study publicly available on registry
May 19, 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, 2021
CompletedMay 19, 2016
May 1, 2016
3 years
May 2, 2016
May 17, 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 (3)
Overall survival
3-year
Adverse events (mortality and morbidity)
3-month
The proportion of completion of laparoscopic surgery
1-month
Study Arms (2)
Laparoscopic surgery
NO INTERVENTIONPatients with T4 colon cancer receive laparoscopic surgery only.
Neoadjuvantive chemotherapy + Laparoscopic surgery
EXPERIMENTALPatients with T4 colon cancer receive neoadjuvantive chemotherapy and laparoscopic surgery.
Interventions
4 cycles of XELOX or FOLFOX neoadjuvant chemotherapy before surgery
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 lesions 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, life expectancy \> 12 weeks
- Operable patients
- Completion of neoadjuvant systemic chemotherapy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
- Shanghai Jiao Tong University School of Medicinecollaborator
- Zhejiang Universitycollaborator
- Tongji Universitycollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xinxiang Li, MD,PhD
Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 2, 2016
First Posted
May 19, 2016
Study Start
October 1, 2016
Primary Completion
October 1, 2019
Study Completion
October 1, 2021
Last Updated
May 19, 2016
Record last verified: 2016-05