Gastric CancerPhase 2/3eNCIT-JapanNCT00503321

Phase II Study of TS-1 Therapy and TS-1+PSK Therapy Against Advanced Gastric Carcinoma

A Phase 2/3 study testing Tegafur/gimeracil/oteracil potassium (S-1), Krestin (PSK) and Tegafur/gimeracil/oteracil potassium (S-1) in people with Gastric Cancer, run by Eastern Network of Cancer Immunological Therapy, Japan at 1 site in Japan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

A randomized controlled study is conducted on unresectable advanced gastric carcinoma and recurrent gastric carcinoma to compare TS-1 therapy with TS-1 + PSK therapy. The primary endpoint of this study is progression-free survival (PFS), with secondary endpoints of anticancer effect, time to treatment failure (TTF)… Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Gastric Cancer
What is being tested?: Tegafur/gimeracil/oteracil potassium (S-1), Krestin (PSK) and Tegafur/gimeracil/oteracil potassium (S-1)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 1 siteJapan
Study dates: Oct 2006to Aug 2011
Phase: Phase 2/3
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

Patients with unresectable advanced gastric carcinoma and recurrent gastric carcinoma.
Patients who are 20 years old or older at the time of obtaining consent.
Patients who have not received prior treatment, including radiotherapy, chemotherapy and immunotherapy, before the start of treatment (however, patients are excluded when six months or more have passed since they received postoperative adjuvant chemotherapy.)
Patients who do not develop metachronous or simultaneous multi cancer.
Patients who do not show severe impairments in renal function, liver function and bone marrow function and who maintain the major organ functions which meet all requirements as described below (laboratory values are values measured before the start of protocol treatment and should be updated ones which are measured within two weeks before protocol treatment is started.) WBC counts: >= 3,000 /mm3 and < 12,000 /mm3 Neutrophil counts (ANC): >= 1,500 /mm3 Platelet counts: >= 100,000 /mm3 Amount of hemoglobin: >= 8.0 g/dL Serum GOT and GPT: Less than 100 IU/L Serum total bilirubin: Less than 1.5 mg/dL Serum creatinine: Less than 1.5 mg/dL
Patients whose performance status scores are 0 to 2.
Patients who are judged that they can endure this treatment in a comprehensive manner and who have provided written informed consent to participate in this research.
Presence or absence of measurable lesion does not matter, but if there are measurable lesions in patients, the lesions should be confirmed within 28 days before the enrollment.

Who cannot join

Patients with fresh blood in the digestive tract.
Patients with body fluids which require treatment.
Patients with infectious disease, intestinal paresis and ileus.
Patients with diarrhea (watery stool).
Female patients who are pregnant or want to become pregnant during this study or male patients who intend to make someone pregnant during this study.
Diabetic patients who are being treated with insulin or are poorly controlled.

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Patients with ischemic heart disease which require treatment
Patients who are complicated with psychosis and judged that it is difficult for them to participate in this study.
Patients who continue to receive steroids.
Patients who have experienced serious drug allergy in the past.
Patients who are taking health foods including agaricus which are considered to have immunostimulating effects.
Patients judged to be inappropriate for this study by investigators and sub-investigators.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Shizuoka Cancer Center
Shizuoka, Shizuoka, 411-8777

Other trials in Japan

About this study

Official title: Randomized Phase II Study of TS-1 Therapy and TS-1+PSK Therapy Against Unresectable Advanced Gastric Carcinoma and Recurrent Gastric Carcinoma

Read the detailed description

Tegafur / gimeracil / oteracil potassium (TS-1) is widely used as a first-line drug for unresectable advanced gastric carcinoma and recurrent gastric carcinoma in Japan and the response rate of TS-1 against gastric carcinoma was reported to be excellent at 46.5% in a phase II study. However, since adverse drug reactions tend to occur in patients treated with standard regimen of TS-1, drug reduction or discontinuation is often required, which is one drawback of this drug. On the other hand, although Krestin (PSK) has been reported to show survival effects in postoperative immunochemotherapy against gastric carcinoma, the efficacy of PSK has not been established in patients with unresectable advanced gastric carcinoma and recurrent gastric carcinoma. Since the main effect of PSK was to recover physiological functions, including immune function of the host, it was expected that PSK would improve the compliance of TS-1 by alleviating adverse drug reactions of TS-1 therapy and the concomitant use of TS-1 with PSK would result in the improvement of treatment results. Therefore, we decided to conduct a randomized phase II study on patients with unresectable advanced gastric carcinoma and recurrent gastric carcinoma to compare TS-1 therapy with TS-1+PSK therapy.

Conditions: Gastric Cancer
Being tested: Tegafur/gimeracil/oteracil potassium (S-1), Krestin (PSK), Tegafur/gimeracil/oteracil potassium (S-1)
Keywords: gastric cancer, TS-1, PSK
Medical subject headings: Stomach Neoplasms

What participants receive

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

Tegafur/gimeracil/oteracil potassium (S-1), Krestin (PSK)Drug
Also called S-1 plus PSK
S-1 80mg/m2 4weeks on 2 weeks off, PSK 3g/day
Tegafur/gimeracil/oteracil potassium (S-1)Drug
Also called S-1 alone
S-1 80mg/m2, 4weeks on followed by 2 weks off

Study groups in NCT00503321
Study group	Role	What they receive
Arm B	Experimental	S-1 plus PSK group Receives: Drug: Tegafur/gimeracil/oteracil potassium (S-1), Krestin (PSK)
Arm A	Active comparator	S-1 alone Receives: Drug: Tegafur/gimeracil/oteracil potassium (S-1)

What is being measured

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

progression-free survival
Measured: 6 months

Secondary outcomes (1)

Anticancer effect, time to treatment failure (TTF), QOL (FACT-BRM), compliance, adverse drug reactions and immunological factors
Measured: 6 months

Timeline

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

Oct 2006Aug 2011

First posted18 Jul 2007 (estimated)
Study startOct 2006
Primary completionAug 2009 (estimated)
Study completionAug 2011 (estimated)

Why it stopped: Patients' enrollment was not sufficient.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Gastric CancerStudies of the same condition, open and under way.
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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00503321
Sponsor's protocol ID: ENCITJ-GC01
Acronym: eNCIT-Japan
Status last verified: Jan 2009
First submitted: 16 Jul 2007
Last updated: 23 Jan 2009
Results posted: No
Data monitoring committee: Yes

Publications

Nakazato H, Koike A, Saji S, Ogawa N, Sakamoto J. Efficacy of immunochemotherapy as adjuvant treatment after curative resection of gastric cancer. Study Group of Immunochemotherapy with PSK for Gastric Cancer. Lancet. 1994 May 7;343(8906):1122-6. doi: 10.1016/s0140-6736(94)90233-x.
PubMed 7910230

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Phase II Study of TS-1 Therapy and TS-1+PSK Therapy Against Unresectable Advanced Gastric Carcinoma and Recurrent Gastric Carcinoma
ClinicalTrials.gov ID: NCT00503321
Acronym / sponsor ID: eNCIT-Japan / ENCITJ-GC01
Conditions: Gastric Cancer
Keywords: gastric cancer, TS-1, PSK
Phase: Phase 2/3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Patients' enrollment was not sufficient.
Enrolment: 13 participants (actual)
Lead sponsor: Eastern Network of Cancer Immunological Therapy, JapanUniversity, hospital or other
Study start: Oct 2006
Primary completion: Aug 2009 (estimated)
Study completion: Aug 2011 (estimated)
First posted: 18 Jul 2007 (estimated)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm B	Experimental	Drug: Tegafur/gimeracil/oteracil potassium (S-1), Krestin (PSK)S-1 plus PSK group
Arm A	Active comparator	Drug: Tegafur/gimeracil/oteracil potassium (S-1)S-1 alone

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Patients with unresectable advanced gastric carcinoma and recurrent gastric carcinoma.
Patients who are 20 years old or older at the time of obtaining consent.
Patients who have not received prior treatment, including radiotherapy, chemotherapy and immunotherapy, before the start of treatment (however, patients are excluded when six months or more have passed since they received postoperative adjuvant chemotherapy.)
Patients who do not develop metachronous or simultaneous multi cancer.
Patients who do not show severe impairments in renal function, liver function and bone marrow function and who maintain the major organ functions which meet all requirements as described below (laboratory values are values measured before the start of protocol treatment and should be updated ones which are measured within two weeks before protocol treatment is started.) WBC counts: >= 3,000 /mm3 and < 12,000 /mm3 Neutrophil counts (ANC): >= 1,500 /mm3 Platelet counts: >= 100,000 /mm3 Amount of hemoglobin: >= 8.0 g/dL Serum GOT and GPT: Less than 100 IU/L Serum total bilirubin: Less than 1.5 mg/dL Serum creatinine: Less than 1.5 mg/dL

Key exclusion criteria (12 listed)

Patients with fresh blood in the digestive tract.
Patients with body fluids which require treatment.
Patients with infectious disease, intestinal paresis and ileus.
Patients with diarrhea (watery stool).
Female patients who are pregnant or want to become pregnant during this study or male patients who intend to make someone pregnant during this study.

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
Tegafur/gimeracil/oteracil potassium (S-1), Krestin (PSK)Also: S-1 plus PSKS-1 80mg/m2 4weeks on 2 weeks off, PSK 3g/day	Drug	Arm B
Tegafur/gimeracil/oteracil potassium (S-1)Also: S-1 aloneS-1 80mg/m2, 4weeks on followed by 2 weks off	Drug	Arm A

Primary outcome

progression-free survival
Time frame: 6 months

1 secondary outcome

Anticancer effect, time to treatment failure (TTF), QOL (FACT-BRM), compliance, adverse drug reactions and immunological factors
Time frame: 6 months

Results and safety

The study was stopped early (reason given: Patients' enrollment was not sufficient.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2009.
Background: PubMed 7910230Nakazato H, Koike A, Saji S, Ogawa N, Sakamoto J. Efficacy of immunochemotherapy as adjuvant treatment after curative resection of gastric cancer. Study Group of Immunochemotherapy with PSK for Gastric Cancer. Lancet. 1994 May 7;343(8906):1122-6. doi: 10.1016/s0140-6736(94)90233-x.

Related trials for Gastric Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
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RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
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Active, not recruitingEarly Phase 1
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B-ALL, DLBCL

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.

Hideaki Tahara, MD study chair

Eastern Network of Cancer Immunological Therapy, Japan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 12 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: stopped early, as of the sponsor's last update on 23 Jan 2009. 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 Japan. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 was stopped early (reason given: Patients' enrollment was not sufficient.). 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?

progression-free survival (time frame: 6 months). 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 NCT00503321, which also lists 1 linked publication.

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 Jan 2009.