Oxaliplatin+Gemcitabine vs Capecitabine as Adjuvant Therapy for Intrahepatic Cholangiocarcinoma

Cholangiocarcinoma Clinical Trial

Official title:

Oxaliplatin Plus Gemcitabine Versus Capecitabine Alone as Adjuvant Treatment in the Prevention of Recurrence of Intrahepatic Cholangiocarcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02548195
• Other study ID #: gemoxicc
• Status: Recruiting
• Phase: Phase 3
• First received: August 7, 2015
• Last updated: September 11, 2015
• Start date: July 2015
• Est. completion date: December 2018

Study information

• Verified date: September 2015
• Source: Shanghai Zhongshan Hospital
• Contact: Hui-Chuan Sun, MD, PhD
• Phone: +86 21 04041990
• Email: sun.huichuan[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

chemotherapy: GEMOX vs capecitabine alone; adjuvant settings; primary endpoint: recurrence-free survival (RFS); second endpoint: overall survival after surgery (OS).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 286
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Liver Neoplasms

Intervention

Drug:
• oxaliplatin and gemcitabine
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.
• capecitabine
capecitabine 1250 mg/m2, twice daily for two weeks plus one week rest for 8 cycles in total.

Locations

Country	Name	City	State
China	Zhongshan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View Citation

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 a — View Citation

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. — View Citation

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 oxalipl — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with adverse events and severe adverse events	All toxicities will be graded by CTCAE v4	from the date of first dosage to safety follow-up visit (30 days after the last dosage)	Yes
Primary	Recurrence-free survival		from the date of surgery to the date of tumor recurrence up to 36 months after surgery	No
Secondary	Overall survival		from the date of surgery to the date of death up to 36 months after surgery	No