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Recurrent or Metastatic Gastric CancerPhase 2NCT01283204

Trial of 4-regimen (SP, FL/Tax, FL/Doc, FOLFOX) in Patients With Recurrent or Metastatic Gastric Cancer

A Phase 2 study testing SP, FL/Tax and FL/Doc in people with Recurrent or Metastatic Gastric Cancer, run by Yonsei University at 1 site in South Korea.

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

This study is to evaluate the antitumor activity (i.e. progression free survival, overall survival, response rate, etc), safety and quality of life in patient with recurrent or metastatic gastric cancer during 4-regimen (i.e. SP, FL/Tax, FL/Doc, FOLFOX) based chemotherapy. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Recurrent or Metastatic Gastric Cancer
What is being tested?
SP, FL/Tax and FL/Doc
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteSouth Korea
Study dates
9 Mar 2010to 25 Jul 2016
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed adenocarcinoma of the stomach
  • Unresectable metastatic disease or recurred AGC
  • Age ≥ 20 years old
  • Eastern Cooperative Oncology Group performance status 0-2
  • Estimated life expectancy > 12weeks
  • Patients with pre-treatment(radiotherapy, chemotherapy) is not carried out. (However, adjuvant chemotherapy using one kind of medication is allowed. It must passed more than 6 months since end of the treatment.) Conventional radiation therapy should be performed before more than 2 weeks. And it is not allowed radiation therapy on primary tumor, measurable lesions, and abdominal
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  • According to RECIST ver.1.1, using imaging techniques (CT or MRI), measurement possible disease or not measurable, but assessable disease
  • Screening laboratory values within the following limits : Hemoglobin ≥ 9 g/dL, Absolute neutrophil count ≥ 1.5 x 10³/L, Platelet count ≥ 75 x 10³/L, Serum creatinine ≤ 1.5 x UNL, Creatinine clearance ≥ 50 mL/min, AST/ALT ≤ 5.0 x UNL
  • The patient or protector have to sign a consent form. And he should be able to understand the right to withdraw consent without disadvantage.

Who cannot join

  • Prior chemotherapy (however, previous (neo-)adjuvant chemotherapy allowed if finished at least 6month ago except S-1, Paclitaxel, Docetaxel, Oxaliplatin . Allowed 5-FU, Cisplatin if finished 6month ago)
  • Patients with oral intake is impossible or with malabsorption syndrome
  • Patients with medically uncontrolled severe complications or infection
  • Patients who have central nervous system disorders, mental disorders, or evidence of CNS metastases
  • Patient with diagnosed active overlapping cancer within the past 5years except adequately treated carcinoma insitu of the cervix, basal or squamous cell carcinoma of skin
  • The possibility(will) of pregnancy , or pregnant and lactating women
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  • Patients with clinically significant heart disease
  • Progression of gastric lesions is not possible to evaluate
  • During clinical trials, patient receiving of systemic chemotherapy or other clinical trials drugs or radiotherapy (However, it is possible that palliative radiotherapy treatment for pain relief on primary lesion after more than 2 weeks)
  • Peripheral neuropathy of Grade 2 or greater.
  • Patients who taking drugs to change of pharmacological activity of S-1 medicine(Warfarin, phenytoin, allopurinol etc.). Except regular treatment of corticosteroids(or equivalent drugs). However, it is allowed the purposes for pre-treatment of study drugs and the control of nausea and vomiting. (However, it is allowed the treatment for acute allergic reactions, or the treatment with low doses (methylprednisolone 20mg or less, or the equivalent drug) from about 6 months)
  • Other cases
  • Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety.
  • Psychological condition or dementia that would not permit the subject to complete the study or sign informed consent
  • Patients with dropout sure in clinical trials or cannot be regular follow-up following reasons. For example, psychological, social, family, geographic reasons or a difficult condition of compliance with clinical trial and proper follow up.
  • Poorly controlled chronic liver disease or diabetes mellitus
  • Else, in the investigator's opinion, should exclude the patient from the study.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Severance Hospital

    Seoul, 120-752

Other trials in South Korea

About this study

Official title: Randomized Phase II Trial of 4-regimen (SP, FL/Tax, FL/Doc, FOLFOX) in Patients With Recurrent or Metastatic Gastric Cancer

This study is to evaluate the antitumor activity (i.e. progression free survival, overall survival, response rate, etc), safety and quality of life in patient with recurrent or metastatic gastric cancer during 4-regimen (i.e. SP, FL/Tax, FL/Doc, FOLFOX) based chemotherapy. In addition, it is to evaluate efficacy and adverse events of anticancer agents according to the results of pharmacogenetic study.

Being tested
SP, FL/Tax, FL/Doc, FOLFOX
Medical subject headings
Recurrence, Stomach Neoplasms

What participants receive

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

  • SPDrug

    Also called TS-1® with Cisplatin

    <Every 3 weeks>

    1. Day 1~14 : TS-1 80mg/m2/day (PO),
    2. Day 1 : CDDP 60mg/m2/day IVF 2hours,
    3. Day 15~21 : Rest.

  • FL/TaxDrug

    Also called Paclitaxel with Leucovorin with 5-FU

    <Every q 3 weeks>

    1. Day1 : Paclitaxel 175mg/m2 IVF for 2hours
    2. Day1 : Leucovorin 20mg/m2 IVF for 1hour
    3. Day1~3 : 5-FU 1000mg/m2 IVF for 24hours

  • FL/DocDrug

    Also called Docetaxel with Leucovorin with 5-FU

    <Every q 3 weeks>

    1. Day1 : Docetaxel 75mg/m2 IVF for 1hour
    2. Day1 : Leucovorin 20mg/m2 IVF for 1hour
    3. Day1~3 : 5-FU 1000mg/m2 IVF for 24hours

  • FOLFOXDrug

    Also called Oxaliplatin with Leucovorin with 5-FU

    <Every q 2 weeks> D1 : Oxaliplatin 100mg/m2 IVF for 2hours D1 : Leucovorin 20mg/m2 IVF for 1hour D1 : 5-FU 400mg/m2 IV bolus D1~2 : 5-FU 1200mg/m2 IVF for 24hours

Study groups in NCT01283204
Study groupRoleWhat they receive
SP(S-1 with cisplatin)Active comparatorSP <Every 3 weeks> 1. Day 1~14 : TS-1 80mg/m2/day (PO) 2. Day 1 : CDDP 60mg/m2/day IVF 2hours 3. Day 15~21 : Rest
Receives: Drug: SP
FL/Tax(Paclitaxel with Leucovorin with 5-FU)Active comparatorFL/Tax <Every q 3 weeks> 1. Day1 : Paclitaxel 175mg/m2 IVF for 2hours 2. Day1 : Leucovorin 20mg/m2 IVF for 1hour 3. Day1~3 : 5-FU 1000mg/m2 IVF for 24hours
Receives: Drug: FL/Tax
FL/Doc(Decetaxel with Leucovorin with 5-FU)Active comparatorFL/Doc <Every q 3 weeks> 1. Day1 : Docetaxel 75mg/m2 IVF for 1hour 2. Day1 : Leucovorin 20mg/m2 IVF for 1hour 3. Day1~3 : 5-FU 1000mg/m2 IVF for 24hours
Receives: Drug: FL/Doc
FOLFOX(Oxaliplatin with Leucovorin with 5-FU)Active comparatorFOLFOX <Every q 2 weeks> D1 : Oxaliplatin 100mg/m2 IVF for 2hours D1 : Leucovorin 20mg/m2 IVF for 1hour D1 : 5-FU 400mg/m2 IV bolus D1~2 : 5-FU 1200mg/m2 IVF for 24hours
Receives: Drug: FOLFOX

What is being measured

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

  1. progression free survival(PFS)

    Imaging assessments will be performed every 6 weeks until radiographically documented PD(Progressive Disease).

    Measured: 6 weeks

Timeline

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

  1. First posted25 Jan 2011 (estimated)
  2. Study start9 Mar 2010
  3. Primary completion25 Jul 2016
  4. Study completion25 Jul 2016

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
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01283204
Sponsor's protocol ID
4-2009-0596
Status last verified
Jan 2019
First submitted
24 Jan 2011
Last updated
29 Jan 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SP, FL/Tax and FL/Doc in people with Recurrent or Metastatic Gastric Cancer, run by Yonsei University at 1 site in South Korea.

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 9 inclusion and 17 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 29 Jan 2019. 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 South Korea. 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: 6 weeks). 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 NCT01283204.

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 29 Jan 2019.

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