EUCTR2011-001507-13-DEActive, not recruitingPhase 1
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) - HerFLOT
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- AIO-Studien-gGmbH
- Enrollment
- 265
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Histologically confirmed adenocarcinoma of the gastroesophageal junction (AEG I-III) or the stomach (uT2, uT3, uT4, any N category, M0), or any T N+ M0 patient, with the following specifications:
- •- Endosonography and an esophageal-gastro-duodenoscopy
- •- Categorization of gastroesophageal junction tumors according to the classification by Siewert (1987, cf. appendix 2)
- •Detection of an adenocarcinoma with HER2 3+ (IHC) or HER2 2+ (IHC) with amplification proven by FISH, SISH or CISH by an accredited local pathologist (for quality assurance tumor samples have to be available for a subsequent central review)
- •No preceding cytotoxic or targeted therapy
- •Male and female patients aged = 18 years. If able to reproduce, patients must be willing to use highly effective methods of contraception during treatment and for 6 months after the end of treatment (adequate: methods fulfilling the requirements of the Note for guidance on non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals [CPMP/ICH/286/95 mod]). Female patients with reproductive ability must have performed a negative pregnancy test within 7 days of study entry.
- •ECOG = 2
- •Exclusion of distant metastasis by CT of thorax and abdomen, bone scan or MRI (if osseous lesions are suspected due to clinical signs)
- •Laparoscopic exclusion of peritoneal carcinomatosis, if suspected clinically
- •Adequate haematological, hepatic and renal function parameters:
- •Leukocytes = 3000/mm³, platelets = 100,000/mm3
- •Serum creatinine = 1.5 x upper limit of normal, or GFR > 40 ml/min
- •Bilirubin = 1.5 x upper limit of normal, AST and ALT = 3.5 x upper limit of normal, alkaline phosphatase = 6 x upper limit of normal
- •Written patient consent form
- •Normal cardiac ejection fraction, as assessed by echocardiography
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 265
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 265
Exclusion Criteria
- •Known hypersensitivity against trastuzumab, murine proteins, 5-FU, leucovorin, oxaliplatin, or docetaxel
- •Other known contraindications against trastuzumab, 5-FU, leucovorin, oxaliplatin, or docetaxel
- •Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, NYHA III-IV
- •Clinically significant valvular defect
- •Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix
- •Known brain metastases
- •Severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy
- •Other severe internal disease or acute infection
- •Peripheral polyneuropathy > NCI Grade II
- •Chronic inflammatory bowel disease
- •On-treatment participation in another clinical study in the period 30 days prior to inclusion and during the study
- •Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
- •Patients in a closed institution according to an authority or court decision (AMG § 40, Abs. 1 No. 4)
- •Any other concurrent antineoplastic treatment including irradiation
Investigators
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