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| Name | Class |
|---|---|
| Aju Pharm | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Avastin/FOLFIRI with curcumin | Experimental | Patients will receive first line Avastin/FOLFIRI in combination with curcumin-containing supplement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avastin/FOLFIRI | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 years |
| Overall response rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeong-Heum Baek, MD, Ph.D | Gachon University Gil Medical Center | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35695002 | Derived | 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. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D003474 | Curcumin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
|
| Curcumin | Dietary Supplement | Dietary supplement of nanostructured lipid curcumin particle 100mg po bid daily |
|
According to RECIST criteria v1.1
| 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) | 2 years |
| Quality of life (QoL) | QoL measured by the FACT-G (version 4, Korean version) | 2 years |
| Fatigue (FACIT-Fatigue scale (version 4, Korean version) | Fatigue measured by the FACIT-Fatigue scale (version 4, Korean version) | 2 years |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |