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POF Versus FOLFOX Plus IP Paclitaxel in AGC

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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)

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)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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