Explorative Phase II Study of Perioperative Treatment in Patients With Adenocarcinoma of the Gast… (NCT01472029) | Clinical Trial Compass
CompletedPhase 2
Explorative Phase II Study of Perioperative Treatment in Patients With Adenocarcinoma of the Gastroesophageal Junction or Stomach
Germany53 participantsStarted 2011-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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/…
What they're measuring
1
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.
Timeframe: From enrollment to surgery after pre-operative treatment (4 cycles = 8 weeks) for 9 weeks.