Spots Global Cancer Trial Database for Clinical Trial of Chemotherapy Combination Cisplatin-Fluorouracil-Afatinib in Patients With Inoperable Gastric Cancer
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Trial Identification
Brief Title: Clinical Trial of Chemotherapy Combination Cisplatin-Fluorouracil-Afatinib in Patients With Inoperable Gastric Cancer
Official Title: A Phase II, Single-arm Clinical Trial of Administration of Cisplatin and 5- Fluorouracil With Afatinib as First-line Therapy in Patients With Inoperable Gastric or Gastroesophageal Junction Cancer
Study ID: NCT01743365
Interventions
Study Description
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of the combination of Cisplatin,5-Fluorouracil(5FU) and Afatinib as first-line therapy in patients with advanced gastric or gastroesophageal junction cancer. The study will include 55 patients in all. The patients will receive open-label Cisplatin intravenous 75mg/m2 on Day 1, 5FU 750mg/m2 at 24-hour intravenous infusion on Days 1-4, and Afatinib 40mg per os on Days 3-5, 8-12, 15-19. The administration of Afatinib will start on Day 3 of each therapy cycle with an administration interval on each weekend ("Weekday on, Weekend off") for 21 days. Instructions are given on the dose reduction scheme in the presence of toxicity. The administration of the combination Cisplatin-5FU-Afatinib will be continued until disease progression, appearance of significant toxicity, completion of 6 treatment cycles, or withdrawal of consent. At completion of 6 cycles of the combination, in the absence of disease progression, the administration of Afatinib as maintenance monotherapy will be continued until disease progression, appearance of significant toxicity, or withdrawal of consent at the weekday on-weekend off schedule. Imaging will be applied once every 8 weeks, and once every 12 weeks in the Afatinib maintenance therapy phase.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
2nd Dept of Internal Medicine, Agios Savvas Cancer Hospital, Athens, , Greece
Dept of Medical Oncology, 251 Air Force Hospital, Athens, , Greece
2nd Dept of Internal Medicine, General Hospital of Athens "Hippokratio", Athens, , Greece
Oncology Section, Dept of Clinical Therapeutics, General Hospital of Athens "Alexandra", Athens, , Greece
Division of Oncology, 2nd Dept of Internal Medicine, University Hospital "Attikon", Athens, , Greece
2nd Dept of Medical Oncology, Agii Anargiri Cancer Hospital, Athens, , Greece
3rd Dept of Medical Oncology, Agii Anargiri Cancer Hospital, Athens, , Greece
3rd Dept of Medical Oncology, Hygeia Hospital, Athens, , Greece
1st Dept of Medical Oncology, Metropolitan Hospital, Athens, , Greece
2nd Dept of Medical Oncology, Metropolitan Hospital, Athens, , Greece
Dept of Medical Oncology, University Hospital of Heraklion, Heraklion, , Greece
Dept of Medical Oncology, Ioannina University Hospital, Ioannina, , Greece
Division of Oncology, Dept of Internal Medicine, University Hospital of Patras, Patras, , Greece
Dept of Medical Oncology, Papageorgiou General Hospital, Thessaloniki, , Greece
Dept of Medical Oncology, Thermi Clinic S.A, Thessaloniki, , Greece
Contact Details
Name: George Pentheroudakis, Ass.Prof
Affiliation: Dept of Medical Oncology, Ioannina University Hospital
Role: STUDY_CHAIR
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