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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01472029
Other study ID # AIO-STO-0310
Secondary ID 2011-001507-13
Status Completed
Phase Phase 2
First received October 24, 2011
Last updated June 16, 2017
Start date December 2011
Est. completion date September 12, 2016

Study information

Verified date June 2017
Source AIO-Studien-gGmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date September 12, 2016
Est. primary completion date August 25, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
5-FU, leucovorin, docetaxel, oxaliplatin (FLOT), trastuzumab
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
Post-operative treatment trastuzumab mono therapy
Trastuzumab mono therapy for 9 cycles: Trastuzumab 6 mg/kg BW, iv over 1 h on day 1 of each 21 day cycle

Locations

Country Name City State
Germany Tagestherapiezentrum am ITM & III. Medizinische Klinik Universitätsmedizin Mannheim Mannheim

Sponsors (2)

Lead Sponsor Collaborator
AIO-Studien-gGmbH Roche Pharma AG

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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.
From enrollment to surgery after pre-operative treatment (4 cycles = 8 weeks) for 9 weeks.
Secondary R0 resection rate 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. From enrollment to surgery after pre-operative treatment (4 cycles = 8 weeks) for 9 weeks.
Secondary Relapse-free survival 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) From enrollment to end of follow up assessed up to 58 months
Secondary Overall survival 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. From enrollment to end of follow up assessed up to 58 months.
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