Adjuvant chemotherapy with gemcitabine and cisplatin compared to standard of care after curative intent resection of cholangiocarcinoma and muscle invasive gallbladder carcinoma (ACTICCA-1 trial)

Phase 3

Active, not recruiting

• Conditions: cholangiocarcinoma; muscle invasive gallbladder carcinoma; Cancer - Biliary tree (gall bladder and bile duct)

• Registration Number: ACTRN12615001283561
• Lead Sponsor: Australasian Gastro-Intestinal Trials Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-25
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 32

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
5. Adequate hematologic function: ANC larger than or equal to 1.5 x 10^9/L, platelets larger than or equal to 100 x10^9/L, hemoglobin larger than or equal to 9 g/dl or larger than or equal to 5.59 mmol/L
6. Adequate liver function as measured by serum transaminases (AST and ALT) less than or equal to 5 x ULN and bilirubin less than or equal to 3 x ULN
7. Adequate renal function, i.e. serum creatinine less than or equal to 1.5 x ULN, glomerular filtration rate greater than or equal to 50 ml/min (determination of GFR according to local institutional standards, e.g. MDRD, (Appendix E))
8. No active uncontrolled infection, except chronic viral hepatitis under antiviral therapy
9. No concurrent treatment with other experimental drugs or other anti-cancer
therapy, treatment in a clinical trial within 30 days prior to randomization
10.Negative serum pregnancy test within 7 days of starting study treatment in pre-menopausal women and women less than 1 year after the onset of menopause (Note: a negative test has to be reconfirmed by a urine test, should the 7-day window be
exceeded)

Criteria for initial study enrolment:
11.Written informed consent
12.No prior chemotherapy for biliary tract cancer
13.No 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
14.No 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)
15.Absence of psychiatric disorder precluding understanding of information of trial
related topics and giving informed consent
16.No serious underlying medical conditions (judged by the investigator), that could
impair the ability of the patient to participate in the trial
17.Fertile women (< 1 year after last menstruation) and procreative men willing and
able to use effective means of contraception (oral contraceptives, intrauterine
contraceptive device, barrier method of contraception in conjunction with
spermicidal jelly or surgically sterile)
18.No pregnancy or lactation

Additional eligibility criteria for patients to be included in the radiotherapy substudy:
19.R1 (microscopic positive margin)
20.No previous radiotherapy to abdomen

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease free survival by review of 3 or 6 monthly CT/MRI/US[Time from randomisation to date of first observed disease recurrence or death from any cause]