NCT02548195

Brief Summary

To evaluate of adjuvant therapy using oxaliplatin and gemcitabine (GEMOX regimen) versus capecitabine alone chemotherapy in patients who underwent curative surgery for intrahepatic cholangiocarcinoma (ICC) -- a randomized control study.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
286

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2015

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 7, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 14, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

September 14, 2015

Status Verified

September 1, 2015

Enrollment Period

2.9 years

First QC Date

August 7, 2015

Last Update Submit

September 11, 2015

Conditions

Cholangiocarcinoma

Keywords

GEMOXintrahepatic cholangiocarcinomaadjuvant therapyoxaliplatingemcitabinecapecitabinecurative surgery

Outcome Measures

Primary Outcomes (1)

  • Recurrence-free survival

    from the date of surgery to the date of tumor recurrence up to 36 months after surgery

Secondary Outcomes (1)

  • Overall survival

    from the date of surgery to the date of death up to 36 months after surgery

Other Outcomes (1)

  • Number of participants with adverse events and severe adverse events

    from the date of first dosage to safety follow-up visit (30 days after the last dosage)

Study Arms (2)

GEMOX

EXPERIMENTAL

oxaliplatin and gemcitabine (GEMOX regimen): day 1: oxaliplatin 85 mg/m2, gemcitabine 1000 mg/m2; day 8: gemcitabine 1000 mg/m2; every three weeks for 6-8 cycles in total.

Drug: oxaliplatin and gemcitabine

Capecitabine

ACTIVE COMPARATOR

capecitabine 1250 mg/m2, twice daily for two weeks plus one week rest for 8 cycles in total.

Drug: capecitabine

Interventions

oxaliplatin and gemcitabineDRUG

oxaliplatin and gemcitabine (GEMOX regimen): day 1: oxaliplatin 85 mg/m2, gemcitabine 1000 mg/m2; day 8: gemcitabine 1000 mg/m2 every three weeks for 6-8 cycles in total.

Also known as: oxaliplatin, gemcitabine
GEMOX
capecitabineDRUG

capecitabine 1250 mg/m2, twice daily for two weeks plus one week rest for 8 cycles in total.

Also known as: Xeloda
Capecitabine

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ECOG PS≤1;
  • pathologically confirmed adenocarcinoma of bile duct;
  • R1 resection or R0 resection with these risk factors: lymph node metastasis, lymphatic vessel or blood vessel invasion, multiple tumors, tumor size \>5 cm, preoperative CA199\>200 U/mL.
  • postoperative liver function Child Pugh Class A, leukocyte count\>1.5\*10\^9/L, platelet count\>100\*10\^9/L, serum alanine aminotransferase \<1.5\*ULN
  • no tumor recurrence or metastasis on baseline examination
  • no history of radiotherapy or intervention therapy

You may not qualify if:

  • hepatocellular carcinoma, mixed carcinoma of ICC and HCC, or hilar cholangiocarcinoma
  • distant metastasis
  • prothrombin time \>14s
  • severe cardiopulmonary dysfunction
  • severe renal dysfunction
  • bone marrow suppression before the initiation of therapy
  • allergic to fluorouracil, gemcitabine, or platinum
  • gemcitabine was used in combination with radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (6)

  • Siegel R, Naishadham D, Jemal A. Cancer statistics, 2012. CA Cancer J Clin. 2012 Jan-Feb;62(1):10-29. doi: 10.3322/caac.20138. Epub 2012 Jan 4.

    PMID: 22237781BACKGROUND

  • Cho SY, Park SJ, Kim SH, Han SS, Kim YK, Lee KW, Lee SA, Hong EK, Lee WJ, Woo SM. Survival analysis of intrahepatic cholangiocarcinoma after resection. Ann Surg Oncol. 2010 Jul;17(7):1823-30. doi: 10.1245/s10434-010-0938-y. Epub 2010 Feb 18.

    PMID: 20165987RESULT

  • Schmoll HJ, Twelves C, Sun W, O'Connell MJ, Cartwright T, McKenna E, Saif M, Lee S, Yothers G, Haller D. Effect of adjuvant capecitabine or fluorouracil, with or without oxaliplatin, on survival outcomes in stage III colon cancer and the effect of oxaliplatin on post-relapse survival: a pooled analysis of individual patient data from four randomised controlled trials. Lancet Oncol. 2014 Dec;15(13):1481-1492. doi: 10.1016/S1470-2045(14)70486-3. Epub 2014 Nov 12.

    PMID: 25456367RESULT

  • Patt YZ, Jones DV Jr, Hoque A, Lozano R, Markowitz A, Raijman I, Lynch P, Charnsangavej C. Phase II trial of intravenous flourouracil and subcutaneous interferon alfa-2b for biliary tract cancer. J Clin Oncol. 1996 Aug;14(8):2311-5. doi: 10.1200/JCO.1996.14.8.2311.

    PMID: 8708722RESULT

  • Ducreux M, Van Cutsem E, Van Laethem JL, Gress TM, Jeziorski K, Rougier P, Wagener T, Anak O, Baron B, Nordlinger B; EORTC Gastro Intestinal Tract Cancer Group. A randomised phase II trial of weekly high-dose 5-fluorouracil with and without folinic acid and cisplatin in patients with advanced biliary tract carcinoma: results of the 40955 EORTC trial. Eur J Cancer. 2005 Feb;41(3):398-403. doi: 10.1016/j.ejca.2004.10.026.

    PMID: 15691639RESULT

  • Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J; ABC-02 Trial Investigators. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010 Apr 8;362(14):1273-81. doi: 10.1056/NEJMoa0908721.

    PMID: 20375404RESULT

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

OxaliplatinGemcitabineCapecitabine

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Jinpei Huang

    Shanghai Zhongshan Hospital

    STUDY DIRECTOR

Central Study Contacts

Hui-Chuan Sun, MD, PhD

CONTACT

+86 21 04041990sun.huichuan@zs-hospital.sh.cn

Mei-Ling Li

CONTACT

livercongress@zs-hospital.sh.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Director of the Department of Liver Surgery

Study Record Dates

First Submitted

August 7, 2015

First Posted

September 14, 2015

Study Start

July 1, 2015

Primary Completion

June 1, 2018

Study Completion

December 1, 2018

Last Updated

September 14, 2015

Record last verified: 2015-09

Locations

CN(1)