Clinical trial · Interventional
A Randomized Controlled Clinical Trial Comparing Oncological Results and Functional Recovery Between Laparoscopic and Open Method for the Treatment of Advanced Rectal Cancer After Concurrent Chemoradiation Therapy (CCRT)
- 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)
This is a three-year research project. The major aims of this study are to:(1) compare the functional recovery and oncologic results in patients with advance rectal cancer treated by either traditional open or laparoscopic methods by randomized prospective clinical trials;(2) investigate the presence of tumor cells in the peripheral blood of patients undergoing either laparoscopic or open surgery; (3) searching for the clinicopathologic features of advanced rectal cancer after CCRT; (4) conduct the translational research regarding the difference of gene expression and its prognostic significance in advanced rectal cancer before and after chemoradiation therapy by micro-array analysis methods; (5) exploration of the potential stem cells of colorectal cancer using CD-133 cell surface marker.
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 |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic surgery | Procedure | — | UNRESOLVED |
| Traditional open surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Patients with low rectal cancer after CCRT undergoing laparoscopic surgery
- interventionNames
- Procedure: Laparoscopic surgery
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Patients with low rectal cancer after CCRT undergoing traditional open surgery
- interventionNames
- Procedure: Traditional open surgery
Primary outcomes (1)
- measure
- Oncologic Results
- timeFrame
- Every 6 months
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Rectal cancer can be resected by curative and elective surgery. * Rectal adenocarcinoma below peritoneal reflection * American Society of Anesthesiology（ASA） classⅠ to Ⅲ lesions Exclusion Criteria: * Cancer located at upper rectum （above peritoneal reflection） * Distant metastasis * Adjacent organ invasion * Intestinal obstruction * Past colonic surgery * Body mass index（BMI）\>35 kg/m2 * Patients who can not complete the whole treatment protocol of concurrent chemoradiation therapy.
References
Publications (1)
- BACKGROUNDLiang JT, Huang KC, Lai HS, Lee PH, Jeng YM. Oncologic results of laparoscopic versus conventional open surgery for stage II or III left-sided colon cancers: a randomized controlled trial. Ann Surg Oncol. 2007 Jan;14(1):109-17. doi: 10.1245/s10434-006-9135-4. Epub 2006 Oct 25. PMID 17066227