C16 Malignant neoplasm of stomach Malignant neoplasm of stomach
Conditions
Interventions
None listed
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 2Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses. 3Age =18 years at the time of screening. For patients aged T2 N0-3 M0 or T0-4 N1-3 M0] per AJCC 8th edition). GEJC includes Siewert* type 2 and 3 tumor. Siewert* type 1 tumor is also eligible as long as the patient is intended to be treated in the same way as for Siewert type 2 and 3 tumors. (a)Per the judgment of the Investigator, patient must be medically fit for treatment with neoadjuvant FLOT therapy prior to radical surgery. (b)At screening, complete surgical resection of the primary GC/GEJC must be deemed achievable, as assessed by a multidisciplinary evaluation, which must include a board certified GI surgeon (see Section 6.1.3 regarding surgical plan). (c)No prior anti-cancer therapy (eg, chemotherapy, radiation therapy, or chemoradiation therapy) for the current malignancy. 5World Health Organization (WHO)/ECOG performance status (PS) of 0 or 1 at enrollment
Exclusion criteria
Exclusion criteria: 1Patients with peritoneal dissemination (including tumor cells in peritoneal fluid) or distant metastasis 2Patients with adenosquamous cell carcinoma, squamous cell carcinoma, or GI stromal tumor 3History of allogeneic organ transplantation. 4Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn’s disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion: (a)Patients with vitiligo or alopecia (b)Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement (c)Any chronic skin condition that does not require systemic therapy (d)Patients without active disease in the last 5 years may be included but only after consultation with the Sponsor (e)Patients with celiac disease controlled by diet alone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EFS is defined as the time from randomization to the following, according to RECIST 1.1 per BICR assessment and/or locally by pathology testing: 1) Progression that precludes surgery or requires non-protocol therapy, 2) Local or distant recurrence or progression of disease, or 3) death due to any cause. NAME OF THE RESULT: To compare Arm A relative to Arm B on event-free survival (EFS) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Since randomization till progression disease | — |
Secondary
| Measure | Time frame |
|---|---|
| EFS is defined as the time from randomization to the following, according to RECIST 1.1 per BICR assessment and/or locally by pathology testing: 1) Progression that precludes surgery or requires non-protocol therapy, 2) Local or distant recurrence or progression of disease, or 3) death due to any cause. NAME OF THE RESULT: To compare Arm A relative to Arm B on event-free survival (EFS) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Since randomization till progression disease ;Overall survival is length of time from randomization until the date of death due to any cause. NAME OF THE RESULT: To compare Arm A relative to Arm B on overall survival (OS) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Since randomizarion till progression disease ;pCR rate is defined as the proportion of patients who have no residual viable tumor in the resected specimens and as determined by pathology review. NAME OF THE RESULT: To compare Arm A relative to Arm B on pathological complete response (pCR) rate PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Since randomizarion till progression disease | — |
Countries
Argentina, Belgium, Brazil, Canada, Chile, Denmark, France, Germany, Hungary, Japan, Korea South, Netherlands, Poland, Russian Federation, Spain, Taiwan, Turkey, United Kindgdom, United States
Outcome results
None listed