Clinical trial · Interventional
A Randomized, Prospective, Multicenter Study for the Role of Primary Tumor Resection in Colorectal Cancer Patients With Asymptomatic, Synchronous Unresectable Metastasis
NCT01978249CI-TRIAL-00034342terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Because of the difficulties of participant enrollment.
Summary
Brief summary (as posted)
Short description for lay public, include brief statement of the study hypothesis
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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| primary tumor resection (PTR) | Procedure | — | UNRESOLVED |
| Systemic chemotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Chemotherapy first without primary tumor resection
- description
- Patients will receive chemotherapy first without primary tumor resection.
- interventionNames
- Procedure: Systemic chemotherapy
- type
- ACTIVE_COMPARATOR
- label
- Primary tumor resection followed by chemotherapy
- description
- Patients will receive primary tumor resection followed by chemotherapy.
- interventionNames
- Procedure: primary tumor resection (PTR)
Primary outcomes (1)
- measure
- Comparison of the overall survival between patients who underwent primary tumor resection and patients who received chemotherapy without primary tumor resection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Age : between 20 and 90 years old * Histologically confirmed adenocarcinoma of the colon or the upper rectum * Patients with resectable primary colon or upper rectal cancer and unresectable metastatic lesions. * Patients with no primary cancer related symptoms. * ECOG performance status of 0 - 2 * Appropriate organ functions (hepatic transaminases - less than 5 times the normal range; bilirubin - less than 2 times the normal range; creatinine serum - less than 1.5 times the normal range; thrombocyte - more than 100,000/µl; neutrophil - more than 1,500/µl) * ASA score of \< 3 * An informed consent form has been signed by the patient. Exclusion Criteria: * The patient received adjuvant chemotherapy within the past 6 months. * The patient received chemotherapy for metastatic colon cancer. * The patient was planning to have curative surgery for the metastatic lesions. * The primary cancer is unresectable. * Patients with peritoneal carcinomatosis. * Patients with mid and low rectal cancer (\< 10cm) * Patients with primary tumor related complications such as intestinal obstruction, intractable bleeding, and perforation, that needs to be treated. * ASA score of \> 4 * The patient has chronic hepatitis or cirrhosis. An asymptomatic HBV or HCV carrier can participate. * Patients with an active infection, which need antibiotic therapy, during the randomization period. * Pregnant or breastfeeding women * Patients who were enrolled in another clinical trial during the time of enrollment (within the 28 day randomization period). * Patients with another different malignant tumor during the past 5 years. Patients with treated non-melanoma skin cancer or cervical cancer can be enrolled in this study.
References
Publications (1)
- DERIVEDKim CW, Baek JH, Choi GS, Yu CS, Kang SB, Park WC, Lee BH, Kim HR, Oh JH, Kim JH, Jeong SY, Ahn JB, Baik SH. The role of primary tumor resection in colorectal cancer patients with asymptomatic, synchronous unresectable metastasis: Study protocol for a randomized controlled trial. Trials. 2016 Jan 19;17:34. doi: 10.1186/s13063-016-1164-0. PMID 26782254