Clinical trial · Interventional
Laparoscopic Surgery for T4 Tumor of the Colon Cancer
Laparoscopic Surgery for T4 Tumor of the Colon Cancer: A Prospective, Multi-Center, Randomized, Open-Label, Parallel Group Clinical Trial
NCT02852915CI-TRIAL-00023362unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colonic Neoplasms | Colon Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Laparoscopic surgery for T4 colon cancers
- description
- Laparoscopic surgery for T4 colon cancers
- interventionNames
- Procedure: Laparoscopic surgery
- type
- NO_INTERVENTION
- label
- Conventional open surgery for T4 colon cancers
- description
- Conventional open surgery for T4 colon cancers
Primary outcomes (1)
- measure
- Disease free survival
- timeFrame
- 3-year
- description
- calculated from the date of surgery to the date of recurrence
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.