Clinical trial · Interventional
Chemotherapy With or Without Surgery in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed by Surgery
A Randomized Trial of Initial Surgery in Advanced Asymptomatic Colorectal Cancer Patients Receiving Chemotherapy for Metastatic Disease
- 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)
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether chemotherapy is more effective when given alone or together with surgery in treating patients with colorectal cancer. PURPOSE: This randomized phase II/III trial is studying how well chemotherapy works and compares it with surgery followed by chemotherapy in treating patients with metastatic colorectal cancer that can not be removed by surgery.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| systemic chemotherapy | Drug | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Accrual rate in months 10 to 12 (phase II)
- measure
- Overall survival for ≥ 2 years (phase III)
Secondary outcomes (5)
- measure
- Morbidity of surgery (phase II)
- measure
- Percentage of patients who receive chemotherapy following surgery (must be over 80%) (phase II)
- measure
- Morbidity of chemotherapy and surgery (phase III)
- measure
- Quality of life (phase III)
- measure
- Economic evaluation (phase III)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed colorectal cancer * Metastases which are unresectable at presentation * No known unresectable primary tumor on CT/MRI scan * Primary tumor does not require immediate or emergency intervention including surgery, radiotherapy, laser, or stenting * Patients who are treated with colonic stents are eligible * No unequivocal extensive peritoneal metastases PATIENT CHARACTERISTICS: * WHO performance status 0-1 * Must be fit for systemic chemotherapy and surgery * Hemoglobin \> 10.0 g/dL * WBC \> 3.0 x 10\^9/L * Platelet count \> 100 x 10\^9/L * Bilirubin \< 25 μmol/L * GFR \> 50 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months (female) or up to 2 months (male) after completion of study therapy * No history of malignant disease within the past 5 years except for nonmelanomatous skin cancer or carcinoma in situ of the cervix * No serious medical co-morbidity (e.g., uncontrolled inflammatory bowel disease, uncontrolled angina, recent \[within the past 6 months\] myocardial infarction, or another serious medical condition) judged to compromise ability to tolerate chemotherapy and/or surgery PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Concurrent participation in a trial of chemotherapy, if eligible, allowed * Concurrent short-course radiotherapy for operable rectal cancer allowed
References
Publications (0)
Data not yet available