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AzTrials

Malignant Neoplasm of Stomach Stage IVPhase 2NCT02845908

POF Versus FOLFOX Versus FOLFOX Plus ip Paclitaxel in AGC

A Phase 2 study testing POF, FOLFOX and FOLFOX plus PAC(ip) in people with Malignant Neoplasm of Stomach Stage IV, run by Fujian Cancer Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Malignant Neoplasm of Stomach Stage IV
What is being tested?
POF, FOLFOX and FOLFOX plus PAC(ip)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteChina
Study dates
Nov 2015to May 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Rongbo Lin

    Fuzhou, Fujian, 350014

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
POF, FOLFOX, FOLFOX plus PAC(ip)
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • POFDrug

    Paclitaxel plus Oxaliplatin plus Leucovorin plus 5-FU

  • FOLFOXDrug

    Oxaliplatin plus Leucovorin plus 5-FU

  • FOLFOX plus PAC(ip)Drug

    FOLFOX plus intraperitoneally PAC

Study groups in NCT02845908
Study groupRoleWhat they receive
POFExperimentalThe 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
Receives: Drug: POF; Drug: FOLFOX; Drug: FOLFOX plus PAC(ip)
FOLFOX plus PAC(ip)ExperimentalThe 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.
Receives: Drug: POF; Drug: FOLFOX; Drug: FOLFOX plus PAC(ip)
FOLFOXActive comparatorThe 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.
Receives: Drug: FOLFOX; Drug: FOLFOX plus PAC(ip)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival,PFS

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

    Measured: 9 month

Secondary outcomes (5)

  1. Response Rate, RR

    Response rate per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

    Measured: 9 month

  2. Adverse Event（AE）

    Clinical response of treatment according to RESIST v1.1 criteria (ORR, According to NCI CTCAE 4.03 criteria

    Measured: 6month

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

    a quality-of-life instrument for use in international clinical trials in oncology.

    Measured: 6month

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

    EORTC quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy

    Measured: 6 month

  5. Overall Survival(OS)

    The length of time from enrollment until the time of death (OS, overall survival

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2016 (estimated)
  2. Study startNov 2015
  3. Primary completionMay 2018
  4. Study completionMay 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02845908
Sponsor's protocol ID
FNF-004
Status last verified
Mar 2021
First submitted
28 Jun 2016
Last updated
23 Apr 2021
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing POF, FOLFOX and FOLFOX plus PAC(ip) in people with Malignant Neoplasm of Stomach Stage IV, run by Fujian Cancer Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival,PFS (time frame: 9 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02845908.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2021.

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