Gastric CancerPhase 2NCT04149015
Neoadjuvant POF in the Treatment of Locally Advanced Gastric Cancer
A Phase 2 study testing paclitaxel ,oxaliplatin,fluorouracil in people with Gastric Cancer, run by Fujian Cancer Hospital.
Trial summary
This study is a single center, phase II study, to evaluate the effectiveness and safety of POF(paclitaxel plus oxaliplatin plus 5-fluorouracil plus leucovorin) , in the neoadjuvant therapy for patients with advanced/metastatic gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- paclitaxel ,oxaliplatin,fluorouracil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2019to 31 Dec 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years old;
- Patients must have histologically or cytologically confirmed resectable gastric or gastroesophageal junction (GEJ) adenocarcinoma without distant metastases. GEJ adenocarcinoma may be classified according to Siewert's classification type I, II, or III
- Patients may have received no prior chemotherapy.
- 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:
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- 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.
Who cannot join
- Subjects with second primary cancer, besides dermatoma, primary cancer of nervous system, non-metastatic prostatic neoplasms.
- Gastrointestinal bleeding.
- women of child-bearing age must take a negative result of serum pregnancy test within 7 days prior to enrollment, and willing to use appropriate methods of contraception during the trial and 12 weeks after the last trial drug. For men, who willing to use appropriate methods of contraception during the trial and 12 weeks after the last trial drug.
- Ongoing corticosteroid drug therapy.
- With a history of previous severe cardiovascular disease: over grade-two myocardial ischemia or myocardial infarction, congestive hert filure, and myocardial infarction or coagulopathy within 6 months.
- Having got apoplexy or cardiovascular accident within 6 months.
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- Having got severe peripheral vascular disease in clinics.
- Subjects who have a history of psychiatric substance abuse and cannot quit or have mental disorders.
- The researchers concluded that the subjects were not suitable for clinic trial
About this study
Official title: A Phase II Trial of Neoadjuvant POF in the Treatment of Locally Advanced Gastric Cancer
This study is a single center, phase II study, to evaluate the effectiveness and safety of POF(paclitaxel plus oxaliplatin plus 5-fluorouracil plus leucovorin) , in the neoadjuvant therapy for patients with advanced/metastatic gastric cancer.
- Conditions
- Gastric Cancer
- Being tested
- paclitaxel ,oxaliplatin,fluorouracil
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxel ,oxaliplatin,fluorouracilDrug
A 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and leucovorin (400 mg/m2), administered simultaneously over a 2-hour infusion period. Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating every 14 days for 4 cycles.
| Study group | Role | What they receive |
|---|---|---|
| POF | Experimental | A 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and leucovorin (400 mg/m2), administered simultaneously over a 2-hour infusion period. Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating every 14 days for 4 cycles Receives: Drug: paclitaxel ,oxaliplatin,fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete and subtotal regression (TRG1a/b by Becker)
Pathological complete and subtotal regression (TRG1a/b by Becker). TRG1a/b is defined as < 10% residual tumor per tumor bed based on evaluation of the resected esophagogastric specimen in the primary by a pathologist.
Measured: after 4 cycles (each cycle is 14 days) + surgery; i.e. after 12 weeks in total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study startNov 2019 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04149015
- Sponsor's protocol ID
- FNF015
- Status last verified
- Oct 2019
- First submitted
- 18 Oct 2019
- Last updated
- 4 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Neoadjuvant POF in the Treatment of Locally Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT04149015
- Acronym / sponsor ID
- FNF015
- Conditions
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- Nov 2019 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 4 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a single center, phase II study, to evaluate the effectiveness and safety of POF(paclitaxel plus oxaliplatin plus 5-fluorouracil plus leucovorin) , in the neoadjuvant therapy for patients with advanced/metastatic gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| POF | Experimental | Drug: paclitaxel ,oxaliplatin,fluorouracilA 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and leucovorin (400 mg/m2), administered simultaneously over a 2-hour infusion period. Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating every 14 days for 4 cycles |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 18-75 years old;
- Patients must have histologically or cytologically confirmed resectable gastric or gastroesophageal junction (GEJ) adenocarcinoma without distant metastases. GEJ adenocarcinoma may be classified according to Siewert's classification type I, II, or III
- Patients may have received no prior chemotherapy.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1;
- An expected survival of ≥ 3 months;
Key exclusion criteria (9 listed)
- Subjects with second primary cancer, besides dermatoma, primary cancer of nervous system, non-metastatic prostatic neoplasms.
- Gastrointestinal bleeding.
- women of child-bearing age must take a negative result of serum pregnancy test within 7 days prior to enrollment, and willing to use appropriate methods of contraception during the trial and 12 weeks after the last trial drug. For men, who willing to use appropriate methods of contraception during the trial and 12 weeks after the last trial drug.
- Ongoing corticosteroid drug therapy.
- With a history of previous severe cardiovascular disease: over grade-two myocardial ischemia or myocardial infarction, congestive hert filure, and myocardial infarction or coagulopathy within 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| paclitaxel ,oxaliplatin,fluorouracilA 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and leucovorin (400 mg/m2), administered simultaneously over a 2-hour infusion period. Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating every 14 days for 4 cycles. | Drug | POF |
Primary outcome
Pathological complete and subtotal regression (TRG1a/b by Becker)
Time frame: after 4 cycles (each cycle is 14 days) + surgery; i.e. after 12 weeks in total
Pathological complete and subtotal regression (TRG1a/b by Becker). TRG1a/b is defined as < 10% residual tumor per tumor bed based on evaluation of the resected esophagogastric specimen in the primary by a pathologist.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing paclitaxel ,oxaliplatin,fluorouracil in people with Gastric Cancer, run by Fujian Cancer Hospital.
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 18 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Pathological complete and subtotal regression (TRG1a/b by Becker) (time frame: after 4 cycles (each cycle is 14 days) + surgery; i.e. after 12 weeks in total). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2019.