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Clinical Trials/NL-OMON53034
NL-OMON53034
Recruiting
Phase 3

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) - ACTICCA-1

Amsterdam UMC0 sites172 target enrollmentTBD
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ConditionsBiliary tract cancerCholangio/gallblader carcinoma10019815

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Biliary tract cancer
Sponsor
Amsterdam UMC
Enrollment
172
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Amsterdam UMC

Eligibility Criteria

Inclusion Criteria

  • •Eligibility criteria for enrolment phase
  • •1\. Suspicion of or histologically/cytologically confirmed adenocarcinoma of
  • •biliary tract (intrahepatic, hilar or extrahepatic cholangiocarcinoma or muscle
  • •invasive gallbladder carcinoma) scheduled for radical surgical therapy
  • •2\. Written informed consent
  • •3\. No prior chemotherapy for biliary tract cancer
  • •4\. No previous malignancy within 3 years or concomitant malignancy, except:
  • •nonmelanomatous
  • •skin cancer or adequately treated in situ cervical cancer
  • •5\. No severe or uncontrolled cardiovascular disease (congestive heart failure

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Not specified

Similar Trials

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Prophylactic combined chemotherapy for patients with cholangiocarcinoma after curative intent of carcinoma resection and muscle invasive gallbladder carcinoma.Cholangiocarcinoma and gallbladder carcinomaMedDRA version: 20.0Level: LLTClassification code 10017620Term: Gallbladder carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10008593Term: CholangiocarcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
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Prophylactic combined chemotherapy for patients with cholangiocarcinoma after curative intent of carcinoma resection and muscle invasive gallbladder carcinoma.Cholangiocarcinoma and gallbladder carcinomaMedDRA version: 20.0Level: LLTClassification code 10017620Term: Gallbladder carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10008593Term: CholangiocarcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
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