FOLFOX6 Versus mFOLFIRINOX as First Line Chemotherapy in Metastatic Gastric Cancer or Esophagogastric Junction Adenocarcinoma (Type II-III)

Gastric Carcinoma Stage IV Clinical Trial

— IRIGA  

Official title:

FOLFOX6 Versus mFOLFIRINOX as First Line Chemotherapy in Metastatic Gastric or Esophagogastric Junction Adenocarcinoma (Type II-III): Open-label Randomized Phase 2/3 Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04442984
• Other study ID #: 2020-01
• Status: Recruiting
• Phase: Phase 2
• Start date: November 3, 2019
• Est. completion date: November 3, 2024

Study information

• Verified date: April 2021
• Source: Blokhin's Russian Cancer Research Center
• Contact: Tatiana Titova
• Phone: +79152982811
• Email: tatiana.titovadoc[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients with metastatic 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 . One half of the patients gets 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin (FOLFOX6), the others 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Irinotecan (mFOLFIRINOX). Main objective of the study is progression free survival.

Description:

This parallel, randomized, open-label study 326 patients with metastatic ( adenocarcinoma of the stomach or the esophagogastric junction without previous therapy will be included in this study. After randomization patients receive 9 cycles FOLFOX6 or mFOLFIRINOX. Stratification factors include ECOG, site of metastasis, age, pathological subtypes. Efficacy will be evaluated every 3 cycles with RECIST. Toxicity will be assessed with WHO CTC 3.0 every 2 weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 326
• Est. completion date: November 3, 2024
• Est. primary completion date: November 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. histologically confirmed locally advanced, recurrent or metastatic adenocarcinoma of the esophagogastric junction (Siewert type II-III) or the stomach

2. no prior palliative chemotherapy or radiation therapy

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

4. Eastern Cooperative Oncology Group = 2

5. Neutrophils> 2.000/µl

6. Platelets > 100.000/µl

7. Normal value of Serum Creatinin

8. Albumin level > 29 ?/?

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

10. Total Bilirubin less than 1.5 times the ULN

11. Written informed consent.

Exclusion Criteria:

1. Previous palliative cytostatic chemotherapy

2. Cancer relapse

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

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

5. Hypersensitivity against 5- Fluorouracil, Leucovorin, Oxaliplatin, irinotecan

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

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

8. 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)

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

10. Peripheral polyneuropathy > Grad II

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

12. Chronic inflammable gastro-intestinal disease

13. Inclusion in another clinical trial

14. Pregnancy or lactation

15. Hepatitis B or C in the active stage

16. Human immunodeficiency virus(HIV) infected

17. 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

18. Foreigners or persons with limited legal status

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophagogastric Junction Adenocarcinoma Stage IV
• Gastric Carcinoma Stage IV
• Stomach Neoplasms

Intervention

Drug:
• Irinotecan
d1 Irinotecan 180mg/m² every two weeks
• Oxaliplatin
d1 Oxaliplatin 85 mg/m² every two weeks
• 5-FU
d1-2 5-FU 2200 mg/m² every two weeks
• 5-FU
d1 5-FU 250 mg/m² every two weeks
• Leucovorin
d1 Leucovorin 400 mg every two weeks
• 5-FU
d1 5-FU 400 mg/m² every two weeks
• 5-FU
d1-2 5-FU 2400 mg/m² every two weeks

Locations

Country	Name	City	State
Russian Federation	Blokhin's Russian Cancer Research Center	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Blokhin's Russian Cancer Research Center

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival	PFS is defined as the time from the date of randomization to the date of the first documentation of progressive disease or date of death, whichever occurs first. For target lesions (TL), PD was defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD) of TLs, taking as a reference the smallest SLD recorded since the treatment started, or the appearance of one or more lesions. For non-target lesions (NTL), PD was defined as an unequivocal progression of existing NTLs. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up.	36 months
Secondary	Overall Survival (OS)	OS is defined as the time from the date of randomization to the date of death due to any cause. Participants were censored at the last date of tumor measurement, the last date in the study drug log or the date of last follow-up	60 months
Secondary	Percentage of Participants With Confirmed Complete Response (CR) or Partial Response (PR) Determined by Response Evaluation Criteria in Solid Tumors (RECIST)		12 months
Secondary	Duration of Response		12 months
Secondary	Treatment associated toxicities	WHO CTC 3.0	12 months