PECORINO: Perioperative Chemotherapy in Gastric Cancer
Study Details
Study Description
Brief Summary
Patients with resectable adenocarcinoma of the stomach or the esophagogastric junction without previous therapy will be treated with one of two chemotherapy combinations before and after surgery. One half of the patients gets 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Docetaxel (FLOT), the others Oxaliplatin and Capecitabin (XELOX). Main objective of the study is histopathological regression rate.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Detailed Description
284 рatients with resectable (T1b-4 and/or N-/+, M0) adenocarcinoma of the stomach or the esophagogastric junction without previous therapy will be included in this study. After laparocopic staging patients will be randomized to receive preoperatively 4 cycles FLOT or 4 cycles XELOX followed by surgery. Subsequently another 4 cycles of FLOT or 4 cycles XELOX are applicated. Primary endpoint is histopathological regression rate, secondary endpoints are disease-free survival, perioperative morbidity and mortality, correlation between pathological responce and disease-free survival.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: XELOX Oxaliplatin 130 mg/m2, d1 Capecitabine 1000 mg/m² two times per day (BID), d1-14, every 3 weeks (q3w) 4 cycles (12 weeks) pre-OP and 3 cycles (12 weeks) post-OP |
Drug: Capecitabine
1000 mg/m² two times per day (BID), d1-14
Drug: Oxaliplatin
130 mg/m² d1 i.v. every 3 weeks
|
Experimental: FLOT Docetaxel 50mg/m2, d1 5-FU 2600 mg/m², d1 Leucovorin 200 mg/m², d1 Oxaliplatin 85 mg/m², d1 every two weeks (q2w) 4 cycles (8 weeks) pre-OP and 4 cycles (8 weeks) post-OP |
Drug: Docetaxel
50mg/m2, d1, i.v., every 2 weeks
Drug: Oxaliplatin
85 mg/m², d1, i.v., every 2 weeks
Drug: Leucovorin
200 mg/m², d1, i.v., every 2 weeks
Drug: Fluorouracil
2600 mg/m²d1 i.v. every 2 weeks
|
Outcome Measures
Primary Outcome Measures
- Histopathological regression rate (Becker regression criteria) [2 weeks after surgery]
To determine histopathological regression rate after FLOT regimen compared to XELOX regimen in neoadjuvant settings
Secondary Outcome Measures
- Chemotherapy toxicity profile [at the end of XELOX cycle (each cycle is 21 days) and FLOT cycle (each cycle is 14 days)]
To determine and compare toxicity profile in patients receiving XELOX or FLOT regimen
- Surgical complications rate [up to 90th day after surgery]
To determine surgical complication rate and profile after different types of regimens in neoadjuvant settings
- 1-year disease-free survival rate [1 year after surgery]
To determine the efficacy of FLOT regimen compared to XELOX regimen during the first year after the surgery
- Correlation between histopathological regression and disease-free survival [2 years of follow-up after the last cycle of chemotherapy]
To determine correlation between histopathological regression and disease-free survival in different chemotherapeutic settings
- Median overall survival [5 year follow up after the last cycle of chemotherapy]
To determine the efficacy of FLOT regimen compared to XELOX regimen by assessment of overall survival
Eligibility Criteria
Criteria
Inclusion Criteria:
-
cT1b-T4b (cT4b - invasion in diaphragm, parenchyma of liver, spleen, pancreas, abdominal wall, small bowel, colon, distal part of splenic artery)
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cN0-3
-
M0
-
Age: 18 - 80
-
ECOG: 0 - 1
-
Histological type: adenocarcinoma
-
Differentiation grade: G0 - G4
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No previous surgery
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No previous chemotherapy
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No concomitant severe comorbidity
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Written informed consent
Exclusion Criteria:
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cT1a, cT4b (invasion in truncus, hepatic artery, proximal part of splenic artery)
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Presense of distant metastases
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ECOG: 2 - 5
-
Age: <18 and >80
-
Severe concomitant comorbidity
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Ukrainian Society of Clinical Oncology | Mykolaiv | Ukraine | 54001 |
Sponsors and Collaborators
- Ukrainian Society of Clinical Oncology
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 275