Explorative Phase II Study of Perioperative Treatment in Patients With Adenocarcinoma of the Gastroesophageal Junction or Stomach (HerFLOT)

AIO-Studien

Status and phase

Completed

Phase 2

Conditions

Adenocarcinoma of the Stomach

Adenocarcinoma of the Gastroesophageal Junction

Treatments

Drug: 5-FU, leucovorin, docetaxel, oxaliplatin (FLOT), trastuzumab

Drug: Post-operative treatment trastuzumab mono therapy

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01472029

AIO-STO-0310

2011-001507-13 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine the 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.

Enrollment

53 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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
Normal cardiac ejection fraction, as assessed by echocardiography
Written patient consent form

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