POF Versus FOLFOX Plus IP Paclitaxel in AGC

Fujian Provincial Cancer Hospital

Status and phase: Unknown; Phase 2

Conditions: Gastric Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04155671

FNF-018

Details and patient eligibility

About

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.

Enrollment: 260 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-75 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;
• The patient has a PT（prothrombintime） (INR international normalized ratio) < or = to 1.5 and an PTT（Partial Thromboplastin Time）< than or = to 3 seconds above the upper limits of normal if the patientia t is not on anticoagulation. ·If a patient is on full-dose anticoagulants, the following criteria should be met for enrollment:
• 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
• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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260 participants in 2 patient groups

POF

Experimental group

Description:

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

Treatment:

Drug: POF

FOLFOX plus PAC(ip)

Experimental group

Description:

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.

Treatment:

Drug: FOLFOX plus PAC(ip)