FOLFIRINOX vs FLOT Chemotherapy for Resectable Gastric or Esophagogastric Junction Adenocarcinoma

NCT04393584 | Unknown Phase 2

• 1 other identifier: 2019-01
• Study Type: interventional
• Target: 538
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with resectable adenocarcinoma of the stomach or the esophagogastric junction (II-III type by Siewert) 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 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Irinotecan (FOLFIRINOX). Main objective of the study is median overall survival.

Conditions

Stomach Neoplasms; Gastrointestinal Neoplasms; Docetaxel; Oxaliplatin; Fluoruracil; Irinotecan Hydrochloride

Keywords

gastric cancer; pathological complete; FLOT; FOLFIRINOX; gastrectomy; adenocarcinoma of the esophagogastric junction; adenocarcinoma of the stomach

Outcome Measures

Primary Outcomes (1)

• median overall survival

  2 years

Secondary Outcomes (4)

• Pathologic complete response rate

  1 month after surgery

• Disease free survival

  2 years

• Perioperative Morbidity and Mortality

  1 months after surgery

• R0-Resection rate

  1 month after surgery

Study Arms (2)

FOLFIRINOX

EXPERIMENTAL

Irinotecan 180mg/m2 d1, d1-2 5-FU 2450 mg/m², d1 Leucovorin 200 mg/m², d1 Oxaliplatin 85 mg/m², d1 every two weeks (q2w) 4 cycles (4-8 weeks) pre-OP and 4 cycles (6-12 weeks) post-OP

Drug: Irinotecan; Drug: 5-FU; Drug: Leucovorin; Drug: Oxaliplatin

FLOT

ACTIVE COMPARATOR

d1 Docetaxel 50mg/m2, d1-2 5-FU 2600 mg/m², d1 Leucovorin 200 mg/m², d1 Oxaliplatin 85 mg/m² every two weeks (q2w) 4 cycles (4-8 weeks) pre-OP and 4 cycles (6-12 weeks) post-OP

Drug: 5-FU; Drug: Leucovorin; Drug: Oxaliplatin; Drug: Docetaxel

Interventions

Irinotecan DRUG

d1 Irinotecan 180mg/m² every two weeks

FOLFIRINOX

5-FU DRUG

d1-2 5-FU 2450 mg/m² every two weeks

FLOT; FOLFIRINOX

Leucovorin DRUG

d1 Leucovorin 200 mg/m² every two weeks

FLOT; FOLFIRINOX

Oxaliplatin DRUG

d1 Oxaliplatin 85 mg/m² every two weeks

FLOT; FOLFIRINOX

Docetaxel DRUG

d1 Docetaxel 50mg/m2 every two weeks

FLOT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• сT4 cN0 or cT1-4 cN+ histologically proven adenocarcinoma of the esophagogastric junction (Siewert type II-III) or the stomach without distant metastases (M0)
• No previous cytostatic chemotherapy or radiation therapy
• Age 18-70 years (female and male)
• Eastern Cooperative Oncology Group ≤ 2
• Surgical resectability
• Neutrophils\> 2.000/µl
• Platelets \> 100.000/µl
• Normal value of Serum Creatinin
• Albumin level \> 29 г/л
• Aspartate transaminase (AST) or alanine transaminase (ALT) less than 3 times the upper limits of normal (ULN)
• Total Bilirubin less than 1.5 times the ULN
• Written informed consent.

You may not qualify if:

• Previous cytostatic chemotherapy or radiation therapy
• Distant metastases or all primarily not resectable stages
• Cancer relapse
• Complicated gastric cancer (perforation, bleeding, sub or decompensated stenosis, dysphagia IV)
• Diarrhea ≥ 2 according to the criteria of Common Terminology Criteria for Adverse Events (CTCAE) version 4.1;
• Hypersensitivity against 5- Fluorouracil, Leucovorin, Oxaliplatin, Epirubicin and Docetaxel
• Existence of contraindications against 5- Fluorouracil, Leucovorin, Oxaliplatin, Irinotecan or Docetaxel
• Active coronary heart disease, Cardiomyopathy or cardiac insufficiency stage III-IV according to New York Heart Association (NYHA)
• Severe non-surgical accompanying disease or acute infection (uncontrolled arterial hypertension, diabetes mellitus, stroke less than 6 months old, mental disorders, other tumors and others)
• Malignant secondary disease, dated back \< 5 years (exception: In-situ-carcinoma of the cervix uteri, adequately treated skin basal cell carcinoma)
• Peripheral polyneuropathy \> Grad II
• Liver dysfunction (AST)/ALT\>3,0xULN, ALT\>3xULN, Bilirubin\>1,5xULN)
• Serum Creatinin \>1,0xULN
• Chronic inflammable gastro-intestinal disease
• Pregnancy or lactation

Sponsors & Collaborators

• Blokhin's Russian Cancer Research Center: lead

Study Sites (1)

Aleksei Kalinin

Moscow, 115478, Russia

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms; Gastrointestinal Neoplasms

Interventions

Irinotecan; Fluorouracil; Leucovorin; Oxaliplatin; Docetaxel

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Ivan Stilidi, PhD

  NN Blokhin National Medical Research Center of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aleksei Kalinin, Phd

CONTACT

+79197681276; kalininalexey1986@yandex.ru

Sergey Nered, Phd

CONTACT

+79031995078; nered@mail.ru

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: May 19, 2020
• Study Start: January 29, 2019
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2026
• Last Updated: April 13, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)