Clinical trial · Interventional
Laparoscopic Surgery VS Laparoscopic Surgery + Neoadjuvant Chemotherapy for T4 Tumor of the Colon Cancer
Laparoscopic Surgery VS Laparoscopic Surgery + Neoadjuvant Chemotherapy for T4 Tumor of the Colon Cancer: A Prospective, Multi-Center, Randomized, Open-Label, Parallel Group Clinical Trial
- 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)
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
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 |
|---|---|---|---|
| XELOX or FOLFOX chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Laparoscopic surgery
- description
- Patients with T4 colon cancer receive laparoscopic surgery only.
- type
- EXPERIMENTAL
- label
- Neoadjuvantive chemotherapy + Laparoscopic surgery
- description
- Patients with T4 colon cancer receive neoadjuvantive chemotherapy and laparoscopic surgery.
- interventionNames
- Drug: XELOX or FOLFOX chemotherapy
Primary outcomes (1)
- measure
- Disease free survival
- timeFrame
- 3-year
- description
- calculated from the date of surgery to the date of recurrence
Secondary outcomes (3)
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 lesions 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, life expectancy \> 12 weeks * Operable patients * Completion of neoadjuvant systemic chemotherapy Exclusion Criteria: * 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
References
Publications (0)
Data not yet available