POF Versus FOLFOX Plus IP Paclitaxel in AGC

NCT04155671 | Unknown Phase 2 DMC

• 1 other identifier: FNF-018
• Study Type: interventional
• Target: 260
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study was to compare the efficacy and safety of intravenous or intraperitoneal paclitaxel plus FOLFOX as first-line treatment in AGC with peritoneal metastases, a phase II Clinical trial.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival(OS)

  The length of time from enrollment until the time of death

  12 months

Secondary Outcomes (2)

• Adverse Event（AE）

  6month

• Objective Overall Response Rate (ORR)

  6month

Study Arms (2)

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

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: FOLFOX plus PAC(ip)

Interventions

POF DRUG

Paclitaxel plus Oxaliplatin plus Leucovorin plus 5-FU

POF

FOLFOX plus PAC(ip) DRUG

FOLFOX plus intraperitoneally paclitaxel

FOLFOX plus PAC(ip)

Eligibility Criteria

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

You may qualify if:

• years old;
• 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.
• If no histologic confirmation, then the metastases or recurrence will require documentation by a 2nd radiographic procedure (eg. PET/CT scan or MRI in addition to the CT scan). If the imaging procedure does not confirm recurrent or metastatic disease, biopsy confirmation will be required.
• Patients must have ascites or peritoneal carcinomatosis confirmed by image (CT or MR or US or others) operation.
• 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 ≥ 3 months;
• Major organ function has to meet the following criteria; (1) For results of blood routine test:
• Hemoglobin (HB) ≥ 80g / 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 times 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）≤1ULN, Endogenous creatinine clearance rate \>50ml/min;

You may not qualify if:

• \- 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 must have recovered from adverse events from any previous therapy.
• 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.
• 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

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 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: October 31, 2019
• First Posted: November 7, 2019
• Study Start: December 1, 2019
• Primary Completion: November 30, 2022
• Study Completion: June 30, 2023
• Last Updated: November 7, 2019

Record last verified: 2019-11