WHO ICTRP trial
Prophylactic combined chemotherapy for patients with cholangiocarcinoma after…
EUCTR2012-005078-70-DE · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2012-005078-70-DE |
|---|---|
| Public title | Prophylactic combined chemotherapy for patients with cholangiocarcinoma after curative intent of carcinoma resection and muscle invasive gallbladder carcinoma. |
| Scientific title | 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) A randomized, multidisciplinary, multinational AIO/DGAV/DGVS phase III trial. |
| Primary sponsor | University Medical Center Hamburg-Eppendorf |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | Netherlands;Austria;Denmark;United Kingdom;Italy;Australia;Germany |
| Conditions | Cholangiocarcinoma and gallbladder carcinoma MedDRA version: 20.0 Level: LLT Classification code 10017620 Term: Gallbladder carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA… |
| Interventions | Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Capecitabine Other descriptive name: CAPECITABINE Concentration unit: mg/m2 milligram(s)/square meter Concentration type: equal Concentration number: 1250- Pharmaceutical Form… |
| Registration date | Aug 22, 2013 |
| Target size | 781 |
| Secondary IDs | ACTICCA-1 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: