Clinical trial · Interventional
Avastin/FOLFIRI in Combination With Curcumin in Colorectal Cancer Patients With Unresectable Metastasis
First Line Avastin/FOLFIRI in Combination With Curcumin-containing Supplement in Colorectal Cancer Patients With Unresectable Metastasis
NCT02439385CI-TRIAL-00057473completedPhase 2ClinicalTrials.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)
Oral curcumin-containing supplement will be given to colorectal cancer patients with unresectable metastases who will be starting Avastin/FOLFIRI chemotherapy for up to completion of (or withdrawal from) chemotherapy.
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 |
|---|---|---|---|
| Avastin/FOLFIRI | Drug | — | UNRESOLVED |
| Curcumin | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Avastin/FOLFIRI with curcumin
- description
- Patients will receive first line Avastin/FOLFIRI in combination with curcumin-containing supplement
- interventionNames
- Drug: Avastin/FOLFIRI
- Dietary Supplement: Curcumin
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- 2 years
- description
- The primary end point of this study is to evaluate progression-free survival in colorectal cancer patients with unresectable metastasis after treatment with first line Avastin/FOLFIRI in combination with a dietary supplement of nanostructured lipid curcumin particle (Aju Pharm, Korea), which improved biotransformation and bioavailability profiles of curcumin.
Secondary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Age : 20 Years and older * Histologically confirmed adenocarcinoma of the colon or rectum * Patients with primary colon or 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: * Colorectal cancer other than adenocarcinoma * 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. * Patients with peritoneal carcinomatosis. * 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 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)
- DERIVEDJeon Y, Sym SJ, Yoo BK, Baek JH. Long-term Survival, Tolerability, and Safety of First-Line Bevacizumab and FOLFIRI in Combination With Ginsenoside-Modified Nanostructured Lipid Carrier Containing Curcumin in Patients With Unresectable Metastatic Colorectal Cancer. Integr Cancer Ther. 2022 Jan-Dec;21:15347354221105498. doi: 10.1177/15347354221105498. PMID 35695002