ACTRN12615001283561
Active, not recruiting
Phase 3
Efficacy and safety of adjuvant chemotherapy with gemcitabine and cisplatin compared to capecitabine after curative intent resection of cholangiocarcinoma and muscle invasive gallbladder carcinoma (ACTICCA-1)
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- cholangiocarcinoma
- Sponsor
- Australasian Gastro-Intestinal Trials Group
- Enrollment
- 32
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Eligibility criteria for treatment phase:
- •1\. Histologically confirmed non\-metastatic adenocarcinoma of biliary tract
- •(intrahepatic, hilar or extrahepatic cholangiocarcinoma or muscle invasive
- •gallbladder carcinoma) after radical surgical therapy with macroscopically
- •complete resection (mixed tumor entities (HCC/CCA) are excluded) (according to
- •appendix H)
- •2\. Macroscopically complete resection (R0/1\) within 6 (\-16\) weeks before scheduled
- •start of chemotherapy
- •3\. ECOG 0\-1
- •4\. Age greater than or equal to 18 years
Exclusion Criteria
- •\* Prior chemotherapy for biliary tract cancer
- •\* Previous malignancy within 3 years or concomitant malignancy, except: those with a 5 year overall survival rate of more than 90% e.g non\-melanomatous skin cancer or adequately treated in\-situ cervical cancer
- •\* Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, unstable angina pectoris, history of myocardial infarction in the last 3 months, significant arrhythmia
- •\* Presence of psychiatric disorder precluding understanding of information of trial related topics and giving informed consent
- •\* Serious underlying medical conditions (judged by the investigator), that could impair the ability of the patient to participate in the trial
- •\* Fertile women (less than 1 year after last menstruation) and procreative men unwilling and unable to use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile)
- •\* Pregnancy or lactation
Outcomes
Primary Outcomes
Not specified
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