A Randomized Phase III Study Comparing POF With SOX/CAPOX/FOLFOX as a Postoperative Adjuvant Chemotherapy for Curatively Resected Stage III Gastric Cancer

NCT03788226 | Unknown Phase 3 DMC

• 1 other identifier: FNF 014
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

FNF-014 is a randomised, open-label, multicentre, parallel-group, phase 3 study in China to prove superiority of POF over S-1/docetaxel in postoperative adjuvant setting for pStage III gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction).

Conditions

Gastric Cancer Stage III

Outcome Measures

Primary Outcomes (1)

• 3-year disease-free survival

  The time from randomisation to the time of recurrence of the original gastric cancer, development of a new gastric cancer, or death from any cause

  From enrollment to 5 years after treatment

Secondary Outcomes (2)

• overall survival

  From enrollment to 5 years after treatment

• safety (The incidence of chemotherapy related adverse events)

  From enrollment to 1 years after treatment

Study Arms (2)

POF

EXPERIMENTAL

A 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and leucovorin (400 mg/m2), administered simultaneously over a 2-hour infusion period. Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating every 14 days for 12 cycles.

Drug: POF

CAPOX/SOX/FOLFOX

ACTIVE COMPARATOR

CAPOX: IV oxaliplatin given over 120 min at a dose of 130 mg/m2 on day 1, oral capecitabine 1000 mg/m2 twice daily on days 1 through 14 every 21 days for 8 cycles. SOX: Oxaliplatin 130mg/m2 IV on D1 every 21 days and S-1 80mg/m2/day PO \[BSA \<1.25 40mg bid (total 80mg/day); BSA ≥1.25 - \<1.5 50mg bid (total 100mg/day); BSA ≥1.5 60mg bid (total 120mg/day)\], divided by two on D1-14 every 21 days for 8 cycles. mFOLFOX6: IV oxaliplatin given over 120 min at a dose of 85 mg/m2 on day 1 followed by IV leucovorin 400 mg/m2 over 2h, IV bolus 5-Fluorouracil 400 mg/m2 and IV infusional 5-Fluorouracil 2400 mg/m2 over 46h every 14 days for 12 cycles.

Drug: CAPOX/SOX/FOLFOX

Interventions

POF DRUG

A 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and leucovorin (400 mg/m2), administered simultaneously over a 2-hour infusion period. Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating every 14 days for 12 cycles.

POF

CAPOX/SOX/FOLFOX DRUG

CAPOX: IV oxaliplatin given over 120 min at a dose of 130 mg/m2 on day 1, oral capecitabine 1000 mg/m2 twice daily on days 1 through 14 every 21 days for 8 cycles. SOX: Oxaliplatin 130mg/m2 IV on D1 every 21 days and S-1 80mg/m2/day PO \[BSA \<1.25 40mg bid (total 80mg/day); BSA ≥1.25 - \<1.5 50mg bid (total 100mg/day); BSA ≥1.5 60mg bid (total 120mg/day)\], divided by two on D1-14 every 21 days for 8 cycles. mFOLFOX6: IV oxaliplatin given over 120 min at a dose of 85 mg/m2 on day 1 followed by IV leucovorin 400 mg/m2 over 2h, IV bolus 5-Fluorouracil 400 mg/m2 and IV infusional 5-Fluorouracil 2400 mg/m2 over 46h every 14 days for 12 cycles.

CAPOX/SOX/FOLFOX

Eligibility Criteria

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

You may qualify if:

• Age 18 to 70 years.
• Histologically proven in gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction) of stage IIIA, IIIB, IIIC with no evidence of metastatic disease.
• Subjects must be able to take orally.
• R0 resection with D2 lymph-node dissection with al least 15 lymph nodes were examined to ensure adequate disease classification.
• Previously untreated except for the initial gastric resection for the primary lesion.
• ECOG performance status ≦ 1.
• Able to start chemotherapy with 42 days after gastrectomy.
• Hgb ≧ 9 g/dL, WBC 4000-12000/mm3, platelets ≧ 100,000/mm3
• Creatine ≦ upper normal limit (UNL)
• Total bilirubin ≦ 1.5 X UNL
• AST, ALT and ALP ≦ 2.5 x UNL
• Life expectancy estimated than 3 months
• Written informed consent

You may not qualify if:

• Active double cancer
• Gastrointestinal bleeding
• Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant
• Definite contraindications for the use of corticosteroids
• Any subject judged by the investigator to be unfit for any reason to participate in the study

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

Study Sites (1)

Rongbo Lin

Fuzhou, 350014, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Rongbo Lin

CONTACT

13705919382; rongbo_lin@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2018
• First Posted: December 27, 2018
• Study Start: February 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2023
• Last Updated: October 16, 2019

Record last verified: 2019-05

Locations

CN (1)