Colorectal CancerPhase 2NCT02439385
Avastin/FOLFIRI in Combination With Curcumin in Colorectal Cancer Patients With Unresectable Metastasis
A Phase 2 study testing Avastin/FOLFIRI and Curcumin in people with Colorectal Cancer, run by Gachon University Gil Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Avastin/FOLFIRI and Curcumin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 24 Aug 2015to 1 Aug 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
About this study
Official title: First Line Avastin/FOLFIRI in Combination With Curcumin-containing Supplement in Colorectal Cancer Patients With Unresectable Metastasis
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
- Colorectal Cancer
- Being tested
- Avastin/FOLFIRI, Curcumin
- Keywords
- Curcumin, Avastin, FOLFIRI, Colorectal cancer, Unresectable metastasis
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avastin/FOLFIRIDrug
Also called Bevacizumab/FOLFIRI
Avastin: 5mg/kg iv on day1, every 14 days. Irinotecan: 180 mg /m2 iv on day1, every 14 days. Leucovorin: 200 mg/m2 iv on day1,2 every 14 days. 5-fluorouracil bolus: 400 mg/m2 iv on day1,2 every 14 days. 5-fluorouracil infusion: 1200 mg/m2 iv on day1,2 every 14 days.
CurcuminDietary supplement
Dietary supplement of nanostructured lipid curcumin particle 100mg po bid daily
| Study group | Role | What they receive |
|---|---|---|
| Avastin/FOLFIRI with curcumin | Experimental | Patients will receive first line Avastin/FOLFIRI in combination with curcumin-containing supplement Receives: Drug: Avastin/FOLFIRI; Dietary Supplement: Curcumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
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.
Measured: 2 years
Secondary outcomes (5)
Overall survival rate
Overall survival will be measured in months. Overall survival will be measured in months. Overall survival will be measured in months. Overall survival will be measured in months.
Measured: 3 years
Overall response rate
According to RECIST criteria v1.1
Measured: 2 years
Safety (assessed by toxicity grades defined by NCI-CTCAE (version 4.0)
Safety as assessed by toxicity grades defined by NCI-CTCAE (version 4.0)
Measured: 2 years
Quality of life (QoL)
QoL measured by the FACT-G (version 4, Korean version)
Measured: 2 years
Fatigue (FACIT-Fatigue scale (version 4, Korean version)
Fatigue measured by the FACIT-Fatigue scale (version 4, Korean version)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study start24 Aug 2015
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Aju Pharm
- Responsible party
- Principal investigator, Jeong-Heum Baek, MD, Gachon University Gil Medical Center
- Investigators
- Jeong-Heum Baek, MD, Ph.D, Principal investigator, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02439385
- Sponsor's protocol ID
- GAIRB2015-87
- Status last verified
- Mar 2022
- First submitted
- 2 May 2015
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 35695002
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Line Avastin/FOLFIRI in Combination With Curcumin-containing Supplement in Colorectal Cancer Patients With Unresectable Metastasis
- ClinicalTrials.gov ID
- NCT02439385
- Acronym / sponsor ID
- GAIRB2015-87
- Conditions
- Colorectal Cancer
- Keywords
- Curcumin, Avastin, FOLFIRI, Colorectal cancer, Unresectable metastasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Collaborators
- Aju Pharm
- Study start
- 24 Aug 2015 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 8 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Avastin/FOLFIRI with curcumin | Experimental | Drug: Avastin/FOLFIRI, Dietary Supplement: CurcuminPatients will receive first line Avastin/FOLFIRI in combination with curcumin-containing supplement |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avastin/FOLFIRIAlso: Bevacizumab/FOLFIRIAvastin: 5mg/kg iv on day1, every 14 days. Irinotecan: 180 mg /m2 iv on day1, every 14 days. Leucovorin: 200 mg/m2 iv on day1,2 every 14 days. 5-fluorouracil bolus: 400 mg/m2 iv on day1,2 every 14 days. 5-fluorouracil infusion: 1200 mg/m2 iv on day1,2 every 14 days. | Drug | Avastin/FOLFIRI with curcumin |
| CurcuminDietary supplement of nanostructured lipid curcumin particle 100mg po bid daily | Dietary supplement | Avastin/FOLFIRI with curcumin |
Primary outcome
Progression-free survival
Time frame: 2 years
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.
5 secondary outcomes
Overall survival rate
Time frame: 3 years
Overall response rate
Time frame: 2 years
Safety (assessed by toxicity grades defined by NCI-CTCAE (version 4.0)
Time frame: 2 years
Quality of life (QoL)
Time frame: 2 years
Fatigue (FACIT-Fatigue scale (version 4, Korean version)
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Derived from this study: PubMed 35695002Jeon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeong-Heum Baek, MD, Ph.D principal investigator
Gachon University Gil Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Avastin/FOLFIRI and Curcumin in people with Colorectal Cancer, run by Gachon University Gil Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02439385, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022; AzTrials last refreshed its copy on 8 Nov 2026.