- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02845908
POF Versus FOLFOX Versus FOLFOX Plus ip Paclitaxel in AGC
April 22, 2021 updated by: Fujian Cancer Hospital
A Phase 2 Study of POF(Paclitaxel/Oxaliplatin/5-Fluorouracil/Leucovorin) Versus FOLFOX Versus FOLFOX Plus Intraperitoneal Paclitaxel as a First-line Treatment in Advanced Gastric Cancer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Fujian
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Fuzhou, Fujian, China, 350014
- Rongbo Lin
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- 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.
Exclusion criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: POF
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
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Paclitaxel plus Oxaliplatin plus Leucovorin plus 5-FU
Oxaliplatin plus Leucovorin plus 5-FU
FOLFOX plus intraperitoneally PAC
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Experimental: 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.
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Paclitaxel plus Oxaliplatin plus Leucovorin plus 5-FU
Oxaliplatin plus Leucovorin plus 5-FU
FOLFOX plus intraperitoneally PAC
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Active Comparator: FOLFOX
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.
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Oxaliplatin plus Leucovorin plus 5-FU
FOLFOX plus intraperitoneally PAC
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-Free Survival,PFS
Time Frame: 9 month
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The length of time from enrollment until the time of progression of disease (PFS, progression-free survival).
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9 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response Rate, RR
Time Frame: 9 month
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Response rate per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
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9 month
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Adverse Event(AE)
Time Frame: 6month
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Clinical response of treatment according to RESIST v1.1 criteria (ORR, According to NCI CTCAE 4.03 criteria
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6month
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The EORTC Core Quality of Life questionnaire (QLQ-C30):
Time Frame: 6month
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a quality-of-life instrument for use in international clinical trials in oncology.
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6month
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EORTC quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy,QLQ-CIPN20
Time Frame: 6 month
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EORTC quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy
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6 month
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Overall Survival(OS)
Time Frame: 12 months
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The length of time from enrollment until the time of death (OS, overall survival
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2015
Primary Completion (Actual)
May 1, 2018
Study Completion (Actual)
May 1, 2020
Study Registration Dates
First Submitted
June 28, 2016
First Submitted That Met QC Criteria
July 22, 2016
First Posted (Estimate)
July 27, 2016
Study Record Updates
Last Update Posted (Actual)
April 23, 2021
Last Update Submitted That Met QC Criteria
April 22, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Neoplasms
- Stomach Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protective Agents
- Micronutrients
- Vitamins
- Antidotes
- Vitamin B Complex
- Fluorouracil
- Oxaliplatin
- Leucovorin
Other Study ID Numbers
- FNF-004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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