MedPath

POF Versus FOLFOX Versus FOLFOX Plus ip Paclitaxel in AGC

Phase 2
Completed
Conditions
Malignant Neoplasm of Stomach Stage IV
Interventions
Drug: POF
Drug: FOLFOX
Drug: FOLFOX plus PAC(ip)
Registration Number
NCT02845908
Lead Sponsor
Fujian Cancer Hospital
Brief Summary

The aim of this study was to compare the efficacy and safety of POF, FOLFOX, and FOLFOX plus paclitaxel(ip) as first-line treatment in AGC a phase II clinical trial.

Detailed Description

The biweekly 5-fluorouracil and leucovorin (LV5FU2) regimen associated with oxaliplatin (FOLFOX) is active in patients with AGC. Meanwhile, Paclitaxel monotherapy is also active in patients with AGC. In previous studies, we found that POF(A combination of oxaliplatin, fluorouracil and Paclitaxel) regimen appears to be of good efficacy and is well tolerated in patients with advanced gastric cancer. This study is being done to find out if three drugs combination maintain manageable side effects but have better benefit than two drugs combination. Intraperitoneal paclitaxel showed high local concentration in abdominal cavity and low systemic toxicity. This study is being done to find out if the combination with Intraperitoneal paclitaxel and FOLFOX have higher local control rate and lower systemic toxicity.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
90
Inclusion Criteria

Not provided

Read More
Exclusion Criteria

Not provided

Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
POFFOLFOXThe POF regimen consisted of a 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and Calcium Levofolinate (200 mg/m2).Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days. The combined chemotheraphy will be treated for 9 circle. then,the capetabine was allowed
POFFOLFOX plus PAC(ip)The POF regimen consisted of a 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and Calcium Levofolinate (200 mg/m2).Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days. The combined chemotheraphy will be treated for 9 circle. then,the capetabine was allowed
FOLFOXFOLFOXThe FOLFOX regimen consisted of oxaliplatin (85 mg/m2) and Calcium Levofolinate (200 mg/m2).Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days.
FOLFOX plus PAC(ip)POFThe regimen consisted of oxaliplatin (85 mg/m2) and Calcium Levofolinate (200 mg/m2) plus paclitaxel (80 mg/m2) intra-peritoneally.Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days.
FOLFOX plus PAC(ip)FOLFOXThe regimen consisted of oxaliplatin (85 mg/m2) and Calcium Levofolinate (200 mg/m2) plus paclitaxel (80 mg/m2) intra-peritoneally.Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days.
FOLFOX plus PAC(ip)FOLFOX plus PAC(ip)The regimen consisted of oxaliplatin (85 mg/m2) and Calcium Levofolinate (200 mg/m2) plus paclitaxel (80 mg/m2) intra-peritoneally.Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days.
POFPOFThe POF regimen consisted of a 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and Calcium Levofolinate (200 mg/m2).Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days. The combined chemotheraphy will be treated for 9 circle. then,the capetabine was allowed
FOLFOXFOLFOX plus PAC(ip)The FOLFOX regimen consisted of oxaliplatin (85 mg/m2) and Calcium Levofolinate (200 mg/m2).Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days.
Primary Outcome Measures
NameTimeMethod
Progression-Free Survival,PFS9 month

The length of time from enrollment until the time of progression of disease (PFS, progression-free survival).

Secondary Outcome Measures
NameTimeMethod
Overall Survival(OS)12 months

The length of time from enrollment until the time of death (OS, overall survival

Response Rate, RR9 month

Response rate per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Adverse Event(AE)6month

Clinical response of treatment according to RESIST v1.1 criteria (ORR, According to NCI CTCAE 4.03 criteria

The EORTC Core Quality of Life questionnaire (QLQ-C30):6month

a quality-of-life instrument for use in international clinical trials in oncology.

EORTC quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy,QLQ-CIPN206 month

EORTC quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy

Trial Locations

Locations (1)

Rongbo Lin

🇨🇳

Fuzhou, Fujian, China

© Copyright 2025. All Rights Reserved by MedPath