Clinical trial NCT02439385: Avastin/FOLFIRI in Combination With Curcumin in Colorectal Cancer Patients With Unresectable Metastasis
Official title: First Line Avastin/FOLFIRI in Combination With Curcumin-containing Supplement in Colorectal Cancer Patients With Unresectable Metastasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Keywords: Curcumin
Avastin
FOLFIRI
Colorectal cancer
Unresectable metastasis
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
Collaborators: name: Aju Pharm
First posted: 2015-05-08
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression-free survival
timeFrame: 2 years
Secondary outcomes:
measure: Overall survival rate
timeFrame: 3 years
measure: Overall response rate
timeFrame: 2 years
measure: Safety (assessed by toxicity grades defined by NCI-CTCAE (version 4.0)
timeFrame: 2 years
measure: Quality of life (QoL)
timeFrame: 2 years
measure: Fatigue (FACIT-Fatigue scale (version 4, Korean version)
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Gachon University Gil Medical Center
name: Jeong-Heum Baek, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jeon 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.