Explorative Phase II Study of Perioperative Treatment in Patients With Adenocarcinoma of the Gastroesophageal Junction or Stomach (HerFLOT)
|Adenocarcinoma of the Gastroesophageal Junction Adenocarcinoma of the Stomach||Drug: 5-FU, leucovorin, docetaxel, oxaliplatin (FLOT), trastuzumab Drug: Post-operative treatment trastuzumab mono therapy||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Multicenter, Explorative Phase II Study of Perioperative 5-FU, Leucovorin, Docetaxel, and Oxaliplatin (FLOT) in Combination With Trastuzumab in Patients With HER2-positive, Locally Advanced, Resectable Adenocarcinoma of the Gastroesophageal Junction or Stomach (HerFLOT)|
- Rate of complete pathological responses (percentage of patients with pCR referring to the total number of enrolled and eligible patients), as evaluated centrally by a reference pathologist. [ Time Frame: From enrollment to surgery after pre-operative treatment (4 cycles = 8 weeks) for 9 weeks. ]
The experimental therapy would be rated as insufficiently active, if the observed pCR rate is 10 % or lower, as this corresponds to the expectations after chemotherapy alone.
The experimental therapy would be considered to be a promising candidate for further development (e.g. in a phase III trial), if the true pCR rate amounted to 20% or more.
- R0 resection rate [ Time Frame: From enrollment to surgery after pre-operative treatment (4 cycles = 8 weeks) for 9 weeks. ]The R0 rate is defined as the number of patients with negative surgical margins and no tumor left macroscopically, divided by the total number of recruited eligible patients.
- Relapse-free survival [ Time Frame: From enrollment to end of follow up assessed up to 58 months ]Relapse-free survival (RFS) will be defined as the time from enrolment to the time of disease progression or relapse or death, or to the date of last tumor assessment without any such event (censored observation)
- Overall survival [ Time Frame: From enrollment to end of follow up assessed up to 58 months. ]The duration of overall survival (OS) will be determined by measuring the time interval from enrolment to the date of death or last observation, including survival rates after 1, 2 and 3 years.
|Study Start Date:||December 2011|
|Study Completion Date:||September 12, 2016|
|Primary Completion Date:||August 25, 2014 (Final data collection date for primary outcome measure)|
|Experimental: 5-FU, leucovorin, docetaxel, oxaliplatin (FLOT), trastuzumab||
Drug: 5-FU, leucovorin, docetaxel, oxaliplatin (FLOT), trastuzumab
Drug: Post-operative treatment trastuzumab mono therapy
Pre-operative treatment 4 cycles and post-operative treatment 4 cycles:
Trastuzumab 4 mg/kg BW (6 mg loading dose at 1st administration), iv over 1 h on day 1 of each 14 day cycle
Docetaxel 50 mg/m², iv over 2 h on day 1 of each 14 day cycle
Oxaliplatin 85 mg/m² in 500 ml G5%, iv over 2h on day 1 of each 14 day cycle
Leucovorin 200 mg/m² in 250 ml NaCl 0,9%, iv over 1 h on day 1 of each cycle
5-FU 2600 mg/m², iv over 24 h on day 1 of each 14 day cycle
Trastuzumab mono therapy for 9 cycles:
Trastuzumab 6 mg/kg BW, iv over 1 h on day 1 of each 21 day cycle
Please refer to this study by its ClinicalTrials.gov identifier: NCT01472029
|Tagestherapiezentrum am ITM & III. Medizinische Klinik Universitätsmedizin Mannheim|
|Mannheim, Germany, D-68167|
|Principal Investigator:||Ralf D Hofheinz, Prof. Dr.||Tagestherapiezentrum am ITM & III. Medizinische Klinik, Universitätsmedizin Mannheim, Theodor-Kutzer-Ufer 1-3, 68167 Mannheim|