POF Versus FOLFOX Versus FOLFOX Plus ip Paclitaxel in AGC

NCT02845908 | Completed Phase 2

• 1 other identifier: FNF-004
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Neoplasm of Stomach Stage IV

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival,PFS

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

  9 month

Secondary Outcomes (5)

• Response Rate, RR

  9 month

• Adverse Event（AE）

  6month

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

  6month

• EORTC quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy,QLQ-CIPN20

  6 month

• Overall Survival(OS)

  12 months

Study Arms (3)

POF

EXPERIMENTAL

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

Drug: POF; Drug: FOLFOX; Drug: FOLFOX plus PAC(ip)

FOLFOX plus PAC(ip)

EXPERIMENTAL

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.

Drug: POF; Drug: FOLFOX; Drug: FOLFOX plus PAC(ip)

FOLFOX

ACTIVE COMPARATOR

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.

Drug: FOLFOX; Drug: FOLFOX plus PAC(ip)

Interventions

POF DRUG

Paclitaxel plus Oxaliplatin plus Leucovorin plus 5-FU

FOLFOX plus PAC(ip); POF

FOLFOX DRUG

Oxaliplatin plus Leucovorin plus 5-FU

FOLFOX; FOLFOX plus PAC(ip); POF

FOLFOX plus PAC(ip) DRUG

FOLFOX plus intraperitoneally PAC

FOLFOX; FOLFOX plus PAC(ip); POF

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years;
• Patients must have histologically or cytologically confirmed metastatic or unresectable gastric or gastroesophageal junction (GEJ) adenocarcinoma. GEJ adenocarcinoma may be classified according to Siewert's classification type I, II, or III. Histological documentation of local recurrence or metastasis is strongly encouraged, unless the risk of such a procedure outweighs the potential benefit of confirming the metastatic disease;
• Patients must have disease that can be measurable radiographically measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1);
• Patients may have received no prior chemotherapy for metastatic or unresectable disease. Patients may have received prior adjuvant therapy (chemotherapy and/or chemoradiation) if more than 6 months have elapsed between the end of adjuvant therapy and registration.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1;
• An expected survival of ≥3months;
• Major organ function has to meet the following criteria: (1) For results of blood routine test: Hemoglobin (HB) ≥80 g/L, ANC (absolute neutrophil count) ≥1.5 × 109/L, PLT (blood platelet) ≥75 × 109/L; (2) For results of biochemical tests: BLT (total bilirubin) ≤1.25 × the upper limit of normal (ULN), ALT (Alanine aminotransferase) and AST (aspartate aminotransferase ) ≤2.5 × ULN, liver metastases, if any, the ALT and AST ≤5 × ULN, Serum Cr（creatinine）≤1 × ULN, Endogenous creatinine clearance rate \>50ml/min;
• The patient has an INR (international normalized ratio) ≤1.5 and an PTT（Partial Thromboplastin Time）≤3 seconds above the ULN if the patient is not on anticoagulation. If a patient is on full-dose anticoagulants, the following criteria should be met for enrollment: (1) The patient must have an in-range INR (usually between 2 and 3) on a stable dose of warfarin or on stable dose of LMW (Low molecular weight) heparin; (2) The patient must not have active bleeding or pathological conditions that carry high risk of bleeding (e.g. tumor involving major vessels, known varices)
• Pregnancy test (serum or urine) has to be performed for woman of childbearing age within 7 days before enrolment and the test result must be negative. Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
• Ability to understand informed consent and signing of written informed consent document prior to initiation of protocol therapy.

You may not qualify if:

• Patients who have ascites requiring frequent drainage;
• Patients who have received previous chemotherapy for the treatment of metastatic or unresectable gastric or GEJ adenocarcinoma are ineligible;
• Patients who have received previous pre- or post-operative chemotherapy or chemoradiation are ineligible if therapy was completed less than 6 months prior to study registration;
• Patients with a history of another neoplastic disease within the past three years, excluding basal cell carcinoma of the skin, cervical carcinoma in situ, or nonmetastatic prostate cancer;
• Patients with brain or central nervous system metastases, including leptomeningeal disease;
• Pregnant (positive pregnancy test) or breast feeding;
• Serious, non-healing wound, ulcer, or bone fracture;
• Significant cardiac disease as defined as: unstable angina, New York Heart Association (NYHA) grade II or greater, congestive heart failure, history of myocardial infarction within 6 months;
• Evidence of bleeding diathesis or coagulopathy;
• History of a stroke or CVA within 6 months;
• Clinically significant peripheral vascular disease;
• Peripheral neuropathy grade ≥2 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03;
• Inability to comply with study and/or follow-up procedures;
• Patients with any other medical condition or reason, in that investigator's opinion, makes the patient unstable to participate in a clinical trial.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

Study Sites (1)

Rongbo Lin

Fuzhou, Fujian, 350014, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Folfox protocol

Condition Hierarchy (Ancestors)

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

Study Officials

• Rongbo Lin, MD

  Fujian Cancer Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: July 27, 2016
• Study Start: November 1, 2015
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2020
• Last Updated: April 23, 2021

Record last verified: 2021-03

Locations

CN (1)