NCT Number: NCT02497157
Bevacizumab + Triplet Treatment for Untreated With Chemotherapy Metastatic Colorectal Cancer
The purpose of this study is to evaluate the efficacy and safety of fluorouracil (5-FU), levofolinate calcium (l-LV), oxaliplatin (L-OHP) and irinotecan hydrochloride hydrate (CPT-11) (FOLFOXIRI) plus bevacizumab in untreated metastatic colorectal cancer patients who harbor Uridine diphosphate (UDP)-glucuronosyl transferase 1A1 (UGT1A1) *1/*1, *1/*6 or *1/*28.
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Notify MeKey information
Conditions
Age range
20 year–70 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Matsuyama Red Cross Hospital, Matsuyama, Ehime, Japan
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Histologically confirmed adenocarcinoma of the colon or rectum.
- Unresectable or recurrent colorectal cancer patient.
- One or more measurable lesion in RECIST ver.1.1 criteria.
- No prior chemotherapy, immunotherapy, and radiotherapy.
- Life expectancy at least 3 months.
- Patients who harbor UGT1A1*1/*1, *1/*6 or *1/*28.
- The Eastern Cooperative Oncology Group (ECOG) performance status of =<1.
- Vital organ functions (listed below) are preserved within 14 days prior to entry.
White blood cell count (WBC): >= 3,000 per cubic millimeter Neu: >= 1,500 per cubic millimeter Platelet count (PLT): >= 100,000 per cubic millimeter Aspartate aminotransferase (AST/GOT) and alanine aminotransferase (ALT/GPT): <= 100 IU/L, <= 150 IU/L in cases with liver metastasis T-bil: <= 1.5 mg/dL Serum creatinine: <= 1.50 mg/dL Proteinuria: <= 1+ Prothrombin time-international normalized ratio (PT-INR): < 1.5
- Written informed consent.
Exclusion criteria
- Vermiform appendix cancer and anal canal cancer.
- Administration of blood products/ granulocyte-colony stimulating factor (G-CSF), and blood transfusion within 14 days prior to enrollment.
- Synchronous multiple malignancy or metachronous multiple malignancy less than 5 years disease free interval.
- Hepatitis B virus antigen (HBs-Ag)(+), or hepatitis C virus antibody (HCV-Ab)(+).
- History of severe allergy.
- Sensory alteration or paresthesia interfering with function.
- Prior radiotherapy for ilium and abdomen.
- Infectious disease.
- Uncontrolled diarrhea.
- Ileus or bowel obstruction.
- Interstitial lung disease or pulmonary fibrosis.
- Malignant coelomic fluid required drainage.
- Administration of atazanavir sulfate.
- Heart disease to be clinically problem.
- Major surgical procedure or intestinal resection within 28 days prior to enrollment or colostomy within 14 days prior to enrollment.
- Known brain metastasis or strongly suspected of brain metastasis.
- History of a thromboembolic disease.
- Receiving anti-platelet drugs.
- Poorly controlled gastrointestinal ulcer.
- History of intestinal perforation within the past 12 months.
- Poorly controlled hypertension.
- Poorly controlled diabetes mellitus.
- Severe mental disorders.
- Women who are pregnant or nursing, men and women who wish to conceive a child or with no intention to contraception.
- Any other cases who are regarded as inadequate for study enrollment by investigators.
Treatment and study plan
Irinotecan hydrochloride hydrate (CPT-11)
DrugContinuous intravenous infusion of fluorouracil (CIV 5-FU)
DrugLevofolinate calcium (l-LV)
DrugBevacizumab (Bmab)
DrugPrimary outcomes
-
Response rate (RR) by response evaluation criteria in solid tumors (RECIST v1.1)
Time frame: Up to 18 months
RR will be calculated as the ratio of the number of eligible patients who experienced a confirmed Complete response(CR) or Partial response(PR) by RECIST v1.1.
Secondary outcomes
-
Time to treatment failure (TTF)
Time frame: Up to 18 months
TTF is defined as the time from date of starting treatment until date of treatment discontinuation, the first documented progression or death from any cause, whichever comes first.
-
Progression-free survival (PFS)
Time frame: Up to 3 years
PFS is defined as the time from date of starting treatment until date of the first documented progression or death from any cause, whichever comes first.
-
Overall survival (OS)
Time frame: Up to 3 years
OS is defined as the time from date of starting treatment until date of death from any cause.
-
R0 resection rate
Time frame: Up to 18 months
R0 resection rate will be calculated as the ratio of the number of eligible patients who experienced a complete (R0) resection.
-
Relative dose intensity (RDI)
Time frame: Up to 18 months
RDI will be calculated as the ratio of actual delivered dose intensity in comparison with planned dose intensity. Dose intensity (DI) is defined as the amount of drug delivered per unit time, expressed in mg/m2/week.
-
Incidence of adverse events
Time frame: Up to 3 years
Other outcomes
-
Early tumor shrinkage (ETS) rates in 8 weeks after starting the treatment, evaluated by RECIST v1.1
Time frame: Baseline (week 0), week 8
ETS will be calculated as the ratio of the number of eligible patients who experienced a 20% or more tumor shrinkage at week 8 compared with baseline.
-
Deepness of response (DoR)
Time frame: Up to 3 years
DoR will be calculated as the median of the maximum tumor shrinkage rates.
Sponsors and collaborators
Lead sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Other
Collaborators
- Hiroshima Prefectural Hospital
- National Hospital Organization Shikoku Cancer Center
Registry information
Official study title
Phase II Trial of FOLFOXIRI + Bevacizumab in Patients With Untreated Metastatic Colorectal Cancer
Acronym: BeTRI
Important dates
- Study start
- 2015
- Primary completion
- 2019
- Study completion
- 2019
- First posted
- Jul 14, 2015
- Registry last updated
- Jun 17, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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