FOLFIRINOX vs FLOT Chemotherapy for Resectable Gastric or Esophagogastric Junction Adenocarcinoma

NCT ID: NCT04393584

Last Updated: 2021-04-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 538 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-29
• Study Completion Date: 2026-01-01

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.

Detailed Description

538 Patients with resectable (cT4cN0 or cT1-4 and cN+, cM0) adenocarcinoma of the stomach or the esophagogastric junction without previous therapy will be included in this study. After randomization patients receive perioperatively 4 cycles FLOT or FOLFIRINOX, followed by a restaging of the tumour status and surgery. Subsequently another 4 cycles of FLOT or FOLFIRNOX are applicated.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FOLFIRINOX

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

Group Type: EXPERIMENTAL

Irinotecan

Intervention Type: DRUG

d1 Irinotecan 180mg/m² every two weeks

5-FU

Intervention Type: DRUG

d1-2 5-FU 2450 mg/m² every two weeks

Leucovorin

Intervention Type: DRUG

d1 Leucovorin 200 mg/m² every two weeks

Oxaliplatin

Intervention Type: DRUG

d1 Oxaliplatin 85 mg/m² every two weeks

FLOT

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

Group Type: ACTIVE_COMPARATOR

5-FU

Intervention Type: DRUG

d1-2 5-FU 2450 mg/m² every two weeks

Leucovorin

Intervention Type: DRUG

d1 Leucovorin 200 mg/m² every two weeks

Oxaliplatin

Intervention Type: DRUG

d1 Oxaliplatin 85 mg/m² every two weeks

Docetaxel

Intervention Type: DRUG

d1 Docetaxel 50mg/m2 every two weeks

Interventions

Irinotecan

d1 Irinotecan 180mg/m² every two weeks

Intervention Type: DRUG

5-FU

d1-2 5-FU 2450 mg/m² every two weeks

Intervention Type: DRUG

Leucovorin

d1 Leucovorin 200 mg/m² every two weeks

Intervention Type: DRUG

Oxaliplatin

d1 Oxaliplatin 85 mg/m² every two weeks

Intervention Type: DRUG

Docetaxel

d1 Docetaxel 50mg/m2 every two weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. сT4 cN0 or cT1-4 cN+ histologically proven adenocarcinoma of the esophagogastric junction (Siewert type II-III) or the stomach without distant metastases (M0)

2. No previous cytostatic chemotherapy or radiation therapy

3. Age 18-70 years (female and male)

4. Eastern Cooperative Oncology Group ≤ 2

5. Surgical resectability

6. Neutrophils> 2.000/µl

7. Platelets > 100.000/µl

8. Normal value of Serum Creatinin

9. Albumin level > 29 г/л

10. Aspartate transaminase (AST) or alanine transaminase (ALT) less than 3 times the upper limits of normal (ULN)

11. Total Bilirubin less than 1.5 times the ULN

12. Written informed consent.

Exclusion Criteria

1. Previous cytostatic chemotherapy or radiation therapy

2. Distant metastases or all primarily not resectable stages

3. Cancer relapse

4. Complicated gastric cancer (perforation, bleeding, sub or decompensated stenosis, dysphagia IV)

5. Diarrhea ≥ 2 according to the criteria of Common Terminology Criteria for Adverse Events (CTCAE) version 4.1;

6. Hypersensitivity against 5- Fluorouracil, Leucovorin, Oxaliplatin, Epirubicin and Docetaxel

7. Existence of contraindications against 5- Fluorouracil, Leucovorin, Oxaliplatin, Irinotecan or Docetaxel

8. Active coronary heart disease, Cardiomyopathy or cardiac insufficiency stage III-IV according to New York Heart Association (NYHA)

9. 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)

10. Malignant secondary disease, dated back < 5 years (exception: In-situ-carcinoma of the cervix uteri, adequately treated skin basal cell carcinoma)

11. Peripheral polyneuropathy > Grad II

12. Liver dysfunction (AST)/ALT>3,0xULN, ALT>3xULN, Bilirubin>1,5xULN)

13. Serum Creatinin >1,0xULN

14. Chronic inflammable gastro-intestinal disease

15. Inclusion in another clinical trial

16. Pregnancy or lactation

17. Hepatitis B or C in the active stage

18. Human immunodeficiency virus(HIV) infected

19. Serious concomitant somatic and mental illnesses / deviations or territorial causes that may prevent the patient from participating in the protocol and observing the protocol schedule

20. Foreigners or persons with limited legal status

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Blokhin's Russian Cancer Research Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ivan Stilidi, PhD

Role: PRINCIPAL_INVESTIGATOR

NN Blokhin National Medical Research Center of Oncology

Locations

Aleksei Kalinin

Moscow, , Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Aleksei Kalinin, Phd

Role: CONTACT

kalininalexey1986@yandex.ru

+79197681276

Sergey Nered, Phd

Role: CONTACT

nered@mail.ru

+79031995078

Facility Contacts

Aleksei Kalinin

Role: primary

kalininalexey1986@yandex.ru

+79197681276

Other Identifiers

2019-01

Identifier Type: -

Identifier Source: org_study_id