Table 2.
Currently active phase III and phase IV studies
| Title | Collaborators | Country/region | Interventions | No of patients | Outcome measures | Recruitment start | Completion date | NCT number |
|---|---|---|---|---|---|---|---|---|
| Palliative setting | ||||||||
| Photodynamic Therapy (PDT) for Palliation of Cholangiocarcinoma | Weill Medical College of Cornell University | US | Photodynamic therapy | 55 | Efficacy profile, safety profile | Feb-12 | Dec-16 | NCT01755013 |
| Effect of Early Management on PAin and DEpression in Patients With PancreatoBiliary Cancer, EPADE-PB |
National Cancer Center, Korea |
Korea | Early palliative care integrated with usual oncologic care | 288 | Reduction in pain scale, reduction in depression score, quality of life, overall survival | Apr-12 | Jun-17 | NCT01589328 |
| Active Symptom Control Alone or With mFOLFOX Chemotherapy for Locally | The Christie NHS Foundation |
UK | mFOLFOX | 162 | Overall survival, progression-free survival, response rate, toxicity, quality | Feb-14 | Jan-18 | NCT01926236 |
| Advanced/Metastatic Biliary Tract Cancers | Trust|Cancer Research UK |
of life, cost-effectiveness | ||||||
| Early Palliative Care With Standard Care or Standard Care Alone in Improving Quality of Life of Patients With Incurable Lung or Non-colorectal Gastrointestinal Cancer and Their Family Caregivers | Alliance for Clinical Trials in Oncology|National Cancer Institute (NCI) |
US | Early palliative care | 700 | Reduction in depression, illness understanding, quality of life, rate of referral, length of hospice stay, location of death, ICU visits, number of patients treated with chemotherapy, overall survival, perceptions of cure | Apr-15 | – | NCT02349412 |
| RFA RCT for Pancreatic or Bile Duct Cancer | Weill Medical College of Cornell University | US | Radiofrequency ablation using EndoHPB probe vs stenting only | 44 | Clinical success, mutational profile of DNA | Jun-14 | Jun-17 | NCT02166190 |
| Chemo Alone or in Combination With Radiation in Unresectable Cholangiocarcinoma |
Tata Memorial Hospital | India | High-dose radiation and systemic chemotherapy | 155 | Overall survival, progression-free survival, toxicity, quality of life, surgical resectability rates | May-15 | Jun-22 | NCT02773485 |
| Safety and Efficacy of Modified Folfirinox Versus Gemcis in Bile Duct Tumours |
Centre Hospitalier Universitaire de Saint Etienne|Federation Francophone de Cancerologie Digestive |
France | Gemcitabine and cisplatin vs mFOLFIRINOX | 316 | Progression-free survival, overall survival, response rate, toxicity | Nov-15 | Jun-18 | NCT02591030 |
| Study of SPARC1507 (Sun Pharma Advanced Research Company Limited Drug) |
Sun Pharma Advanced Research Company Limited |
India | SPARC1507 | 198 | Progression-free survival, overall survival, response rate | Apr-16 | Nov-19 | NCT02597465 |
| Early Palliative Care in Patients With Metastatic Upper Gastrointestinal Cancers Treated With First-line Chemotherapy |
Centre Oscar Lambret|Canceropôle Nord Ouest |
France | Early palliative care | 558 | Overall survival, quality of life, reduction in depression score, time until definitive deterioration, advanced directives, number of patients treated with chemotherapy | Aug-16 | Aug-20 | NCT02853474 |
| Adjuvant setting | ||||||||
| Adjuvant Chemotherapy With Gemcitabine and Cisplatin Compared to Observation After Curative Intent Resection of Biliary Tract Cancer, ACTICCA | Universitätsklinikum Hamburg-Eppendorf|Deutsche Krebshilfe e.V., Bonn (Germany)|medac GmbH|Cancer Research UK|AGITG Australasian Gastro Intestinal Trials Group|KWF Kanker Bestrijding the Netherlands | Europe and Oceania | Gemcitabine and cisplatin | 440 | Disease-free survival, overall survival, toxicity, quality of life, function biliodigestive anastomosis, infections | Apr-14 | Apr-22 | NCT02170090 |
| Oxaliplatin + Gemcitabine vs Capecitabine as Adjuvant Therapy for Intrahepatic Cholangiocarcinoma | Shanghai Zhongshan Hospital | People’s Republic of China | Gemcitabine and cisplatin | 286 | Recurrence-free survival, overall survival | Jul-15 | Dec-18 | NCT02548195 |
Abbreviations: FOLFOX, chemotherapy regimen consisting of folinic acid (leucovorin), 5-fluorouracil (5-FU), and oxaliplatin; FOLFIRINOX, chemotherapy regimen consisting of folinic acid (leucovorin), 5-fluorouracil (5-FU), irinotecan, and oxaliplatin; ICU, intensive care unit; RFA, radiofrequency ablation; RCT, randomized controlled trial.