mFOLFOX vs. mFOLFIRI in Advanced or Recurrent Biliary Tract Cancer Refractory to First Line

• ClinicalTrials.gov Identifier: NCT03464968
• Recruitment Status: Completed
• First Posted: March 14, 2018
• Last Update Posted: December 2, 2020
• Sponsor: Seoul National University Bundang Hospital
• Information provided by (Responsible Party): Jin Won Kim, Seoul National University Bundang Hospital

Tracking Information

• First Submitted Date: March 1, 2018
• First Posted Date: March 14, 2018
• Last Update Posted Date: December 2, 2020
• Actual Study Start Date: July 29, 2015
• Actual Primary Completion Date: February 10, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 12, 2018)

6 months overall survival rate [ Time Frame: 6months ]

at 6 months from intervention treatment, overall survival rate

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 12, 2018)

• response rate [ Time Frame: 6months ]
  complete response, partial response
• disease control rate [ Time Frame: 6months ]
  complete response, partial response, stable disease
• progression free survival [ Time Frame: 6months ]
  from treatment start to progression or any cause of death
• Number of Participants With Treatment-Related Adverse Events as Assessed by NCI CTC version 4.0 [ Time Frame: 6months ]
  percentage of all patients

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: mFOLFOX vs. mFOLFIRI in Advanced or Recurrent Biliary Tract Cancer Refractory to First Line
• Official Title: A Randomized Phase II Study of mFOLFOX vs. mFOLFIRI in Advanced or Recurrent Biliary Tract Cancer Refractory to First Line Gemcitabine Plus Cisplatin
• Brief Summary: In second line with advanced or recurrent biliary tract cancer refractory to first line gemcitabine plus cisplatin, efficacy of mFOLFOX vs. mFOLFIRI will be evaluated at randomized phase 2 trial.

Detailed Description

1. brief enrollment criteria

   • histological confirmed
   • refractory to first line gemcitabine plus cisplatin
   • fit for chemotherapy

2. treatment arms A. mFOLFOX D1 oxaliplatin 100mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks

   B. mFOLFIRI D1 Irinotecan 150mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks

3. randomization - stratified by tumor site and performance status

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Biliary Cancer Metastatic

Intervention

• Drug: Oxaliplatin,5FU, leucovorin
  mFOLFOX
• Drug: irinotecan,5FU, leucovorin
  mFOLFIRI

Study Arms

• Experimental: mFOLFOX
  D1 oxaliplatin 100mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks
  Intervention: Drug: Oxaliplatin,5FU, leucovorin
• Experimental: mFOLFIRI
  D1 Irinotecan 150mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks
  Intervention: Drug: irinotecan,5FU, leucovorin

• Publications *: Choi IS, Kim KH, Lee JH, Suh KJ, Kim JW, Park JH, Kim YJ, Kim JS, Kim JH, Kim JW. A randomised phase II study of oxaliplatin/5-FU (mFOLFOX) versus irinotecan/5-FU (mFOLFIRI) chemotherapy in locally advanced or metastatic biliary tract cancer refractory to first-line gemcitabine/cisplatin chemotherapy. Eur J Cancer. 2021 Sep;154:288-295. doi: 10.1016/j.ejca.2021.06.019. Epub 2021 Jul 22.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 1, 2020): 120
• Original Estimated Enrollment (submitted: March 12, 2018): 118
• Actual Study Completion Date: July 25, 2020
• Actual Primary Completion Date: February 10, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 20 years and older
• pathologically confirmed biliary tract cancer (adenocarcinoma) including intrahepatic, extrahepatic, gallbladder, ampulla of vater
• initially inoperable or recurrent
• ECOG 0-2
• as first line chemotherapy, refractory to gemcitabine/cisplatin (at least one cycle applied)
• evaluable or measurable lesion
• within 1 week, patients who meet below laboratory results (hemoglobin >9.0 g/dL, neutrophil >1000/uL, platelet> 75000/uL, serum creatinine < UNL * 1.5, AST/ALT < UNL*3, total bilirubin < UNL*1.5 (available for biliary drainage)
• patients who have ability to understand the purpose, benefit and harm for this trial, and the right to withdraw this trial in any time without any disadvantage

Exclusion Criteria:

• other cancer history
• pregnant or lactating
• uncontrolled medical condition such as infection or cardiovascular disease
• hypersensitivity to experimental drugs
• uncontrolled CNS metastasis, psychologic problem

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT03464968
• Other Study ID Numbers: biliary second line
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Jin Won Kim, Seoul National University Bundang Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Seoul National University Bundang Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Seoul National University Bundang Hospital
• Verification Date: December 2020