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FOLFIRINOX vs FLOT Chemotherapy for Resectable Gastric or Esophagogastric Junction Adenocarcinoma (RusGCG-01)

B

Blokhin's Russian Cancer Research Center

Status and phase

Enrolling
Phase 3
Phase 2

Conditions

Docetaxel
Oxaliplatin
Irinotecan Hydrochloride
Fluoruracil
Gastrointestinal Neoplasms
Stomach Neoplasms

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04393584
2019-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

538 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

538 participants in 2 patient groups

FOLFIRINOX
Experimental group
Description:
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
Treatment:
Drug: 5-FU
Drug: Leucovorin
Drug: Oxaliplatin
Drug: Irinotecan
FLOT
Active Comparator group
Description:
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
Treatment:
Drug: Docetaxel
Drug: 5-FU
Drug: Leucovorin
Drug: Oxaliplatin

Trial contacts and locations

1

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Central trial contact

Aleksei Kalinin, Phd; Sergey Nered, Phd

Data sourced from clinicaltrials.gov

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