5-FU, Leucovorin, Oxaliplatin and Docetaxel (FLOT) Versus Epirubicin, Cisplatin and 5-FU (ECF) in Patients With Locally Advanced, Resectable Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

A Randomized Multicenter Phase II/III Study Comparing 5-FU, Leucovorin, Oxaliplatin and Docetaxel (FLOT) Versus Epirubicin, Cisplatin and 5-FU (ECF) in Patients With Locally Advanced Resectable Adenocarcinoma of the Esophagogastreal Junction or the Stomach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01216644
• Other study ID #: FLOT4
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: August 2010
• Est. completion date: May 2019

Study information

• Verified date: June 2019
• Source: Krankenhaus Nordwest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients with locally advanced resectable adenocarcinoma of the stomach or the esophagogastreal 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 Epirubicin, Cisplatin and 5-FU (ECF). Main objective of the study is median overall survival.

Description:

714 Patients with locally advanced resectable (T2-4 and/or N+, M0) adenocarcinoma of the stomach or the esophagogastreal junction without previous therapy will be included in this study. After randomization patients receive perioperatively 4 cycles FLOT or 3 cycles ECF, followed by a restaging of the tumour status and surgery. Subsequently another 4 cycles of FLOT or 3 cycles ECF are applicated. Then a central validation of the pathological remission rate is scheduled. Primary endpoint is overall survival, secondary endpoints are disease free survival, perioperative morbidity and mortality, histopathologic regression rate and R0-resection rate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 716
• Est. completion date: May 2019
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. locally advanced (>T1) and/or nodal positive (N+) histologically proven adenocarcinoma of the esophagogastreal junction (AEG I-III) or the stomach without distant metastases (M0) and without infiltration of adjacent structures and organs

2. no previous surgical resection

3. no previous cytostatic chemotherapy

4. Age > 18 years (female and male)

5. ECOG = 2

6. surgical resectability

7. Exclusion of peritoneal carcinomatosis (if clinically suspected) via laparoscopy

8. Leucocytes > 3.000/µl

9. Platelets > 100.000/µl

10. Serum creatinin = 1.5x of normal value, or Creatinin-Clearance > 50 ml/min

11. written informed consent.

12. Ejection fraction > 50% in echocardiography before start of therapy

Exclusion Criteria:

1. distant metastases or infiltration of adjacent structures or organs and all primarily not resectable stages

2. relapse

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

4. Existence of contraindications against 5- Fluorouracil, Leucovorin, Oxaliplatin, Cisplatin, Epirubicin or Docetaxel

5. Active CHD, Cardiomyopathy or cardiac insufficiency stage III-IV according to NYHA

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

7. severe non-surgical accompanying disease or acute infection

8. peripheral polyneuropathy > NCI Grad II

9. severe liver dysfunction (AST/ALT>3,5xULN, AP>6xULN, Bilirubin>1,5xULN)

10. chronic inflammable gastro-intestinal disease

11. inclusion in another clinical trial

12. pregnancy or lactation

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• 5-Fluorouracil
2600 mg/m²d1 i.v. every 2 weeks
• Leucovorin
200 mg/m², d1, i.v., every 2 weeks
• Oxaliplatin
85 mg/m², d1, i.v., every 2 weeks
• Docetaxel
50mg/m2, d1, i.v., every 2 weeks
• Epirubicin
50 mg/m2, d1, i.v., every 3 weeks
• Cisplatin
60 mg/m², d1, i.v., every 3 weeks
• 5-fluorouracil
200 mg/m², d1-d21, i.v., every 3 weeks

Locations

Country	Name	City	State
Germany	Krankenhaus Nordwest	Frankfurt

Sponsors (1)

Lead Sponsor	Collaborator
Krankenhaus Nordwest

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	median overall survival		2 years follow-up
Secondary	histopathological regression rate		6 weeks after surgery
Secondary	disease free survival (DFS)		2 years follow-up
Secondary	correlation of pCR and DFS with survival		2 years follow-up
Secondary	Perioperative Morbidity and Mortality		up to 2 months after surgery
Secondary	R0-Resection rate		2 months after surgery