Gastric CancerPhase 3TMOG-GC01NCT00687843
Study of TS-1 or TS-1 + PSK for Gastric Cancer Patients
A Phase 3 study testing Tegafur-gimeracil-oteracil potassium (TS-1) and Krestin (PSK) in people with Gastric Cancer, run by Tokyo Metropolitan Oncology Group at 1 site in Japan.
Trial summary
Since it is not uncertain about efficacy of combination therapy with PSK and TS-1 in gastric cancer, in this study, we compare efficacy and safety of postoperative adjuvant therapy using TS-1 or TS-1+PSK in the stage II or III gastric cancer patients. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Tegafur-gimeracil-oteracil potassium (TS-1) and Krestin (PSK)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2008to Mar 2016
- Phase
- Phase 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who is pathologically confirmed as gastric cancer
- Patient who has received surgery with D2 or more lymph node dissection and whose final curability of surgical resection is grade A or B
- Patient whose final stage is II (except for T1), IIIA, or IIIB
- Patient without liver, peritoneal and distant metastasis, and who is negative in peritoneal cytological diagnosis
- Patient whose age at the registration is ranging between 20 and 80 years old
- Patient who has not received any preoperative therapy including radiotherapy, chemotherapy and immunotherapy
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- Patient who has received surgery for gastric cancer within six weeks before the registration, and is judged to be capable of oral administration
- Patient who has no serious concurrent complications, and satisfies the following criteria
- White blood cell count: > LLN or > 4,000 /mm3
- Platelet count: > 100,000 /mm3
- Serum total bilirubin: < 1.5 mg/dL
- Serum AST (GOT), ALT (GPT): < 2.5 * ULN
- Serum creatinine: < ULN
- Patient who has received an explanation of this study by assent documents, and has given written informed consent to participate in this study
Who cannot join
- Patient with metachronous or synchronous multicancer
- Patient who contraindicates to TS-1
- Patient who requires continuous use of flucytosine, phenytoin or warfarin potassium
- Patient who has experienced serious drug allergy over grade 3 in the past
- Patient with serious complications including paralysis of intestine, ileus, interstitial pneumonitis, fibroid lung, uncontrollable diabetes mellitus, heart insufficiency, renal insufficiency or hepatic insufficiency
- Patient with diarrhea (watery stool)
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- Patient who is pregnant or in lactation, or wish to become pregnant during this study
- Male patient who intends to make someone pregnant during this study
- Patient with HIV positive
- Patient who is judged to be inappropriate as subject to this study by the principal investigator or the doctors in charge
Trial locations and contacts
1 site in 1 country.
Japan1 site
Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital
Tokyo, Tokyo, 113-8677
About this study
Official title: Phase III Randomized Controlled Study of Postoperative Adjuvant Therapy Using TS-1 or TS-1+PSK for Stage II or III Gastric Cancer Patients
Since it is not uncertain about efficacy of combination therapy with PSK and TS-1 in gastric cancer, in this study, we compare efficacy and safety of postoperative adjuvant therapy using TS-1 or TS-1+PSK in the stage II or III gastric cancer patients.
Read the detailed description
TS-1 is an oral anticancer drug approved in Japan consisting of tegafur (a pro-drug of fluorouracil, 5-FU), gimeracil and oteracil potassium. The response rate of TS-1 in the untreated advanced gastric cancer patients was 44.6% in the late phase II study. In 2007, efficacy of the adjuvant therapy using TS-1 in the resected gastric cancer patients was demonstrated by ACTS-GC study group conducted in Japan. PSK is an oral anticancer drug approved in Japan consisting of protein-bound polysaccharide extracted from mycelium of Trametes (Coriolus) versicolor, a kind of mushroom. Even though survival benefit by PSK in combination with adjuvant chemotherapy using 5-FU or tegafur in the postoperative gastric cancer patients was already demonstrated, it is not uncertain about efficacy of combination therapy with PSK and TS-1 in gastric cancer. In this study, we compare efficacy and safety of postoperative adjuvant therapy using TS-1 or TS-1+PSK in the stage II or III gastric cancer patients.
- Conditions
- Gastric Cancer
- Being tested
- Tegafur-gimeracil-oteracil potassium (TS-1), Krestin (PSK)
- Keywords
- Gastric Cancer, TS-1, PSK, Relapse-free survival
- 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 (TS-1)Drug
Also called TS-1
80 mg/m2, PO from day 1 to day 28 of each 42 day cycle. Number of Cycles: 8
Krestin (PSK)Drug
Also called PSK
3 g, PO from day 1 to day 336
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | The TS-1 group Receives: Drug: Tegafur-gimeracil-oteracil potassium (TS-1) |
| 2 | Experimental | The TS-1+PSK Group Receives: Drug: Tegafur-gimeracil-oteracil potassium (TS-1); Drug: Krestin (PSK) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-free survival
Measured: Five years after surgery
Secondary outcomes (1)
Overall survival, quality of life, drug compliance, adverse events, serial changes of tumor markers
Measured: Five years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tokyo Metropolitan Oncology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoshiaki Iwasaki, M.D., Ph.D., Tokyo Metropolitan Oncology Group
- Investigators
- Masatsugu Kitamura, MD, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00687843
- Sponsor's protocol ID
- TMOG-GC01
- Acronym
- TMOG-GC01
- Status last verified
- Mar 2012
- First submitted
- 28 May 2008
- Last updated
- 22 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sakuramoto S, Sasako M, Yamaguchi T, Kinoshita T, Fujii M, Nashimoto A, Furukawa H, Nakajima T, Ohashi Y, Imamura H, Higashino M, Yamamura Y, Kurita A, Arai K; ACTS-GC Group. Adjuvant chemotherapy for gastric cancer with S-1, an oral fluoropyrimidine. N Engl J Med. 2007 Nov 1;357(18):1810-20. doi: 10.1056/NEJMoa072252.
PubMed 17978289Nakazato 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Controlled Study of Postoperative Adjuvant Therapy Using TS-1 or TS-1+PSK for Stage II or III Gastric Cancer Patients
- ClinicalTrials.gov ID
- NCT00687843
- Acronym / sponsor ID
- TMOG-GC01 / TMOG-GC01
- Conditions
- Gastric Cancer
- Keywords
- Gastric Cancer, TS-1, PSK, Relapse-free survival
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Tokyo Metropolitan Oncology GroupUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 2 Jun 2008 (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.
Since it is not uncertain about efficacy of combination therapy with PSK and TS-1 in gastric cancer, in this study, we compare efficacy and safety of postoperative adjuvant therapy using TS-1 or TS-1+PSK in the stage II or III gastric cancer patients.
Detailed description
TS-1 is an oral anticancer drug approved in Japan consisting of tegafur (a pro-drug of fluorouracil, 5-FU), gimeracil and oteracil potassium. The response rate of TS-1 in the untreated advanced gastric cancer patients was 44.6% in the late phase II study. In 2007, efficacy of the adjuvant therapy using TS-1 in the resected gastric cancer patients was demonstrated by ACTS-GC study group conducted in Japan. PSK is an oral anticancer drug approved in Japan consisting of protein-bound polysaccharide extracted from mycelium of Trametes (Coriolus) versicolor, a kind of mushroom. Even though survival benefit by PSK in combination with adjuvant chemotherapy using 5-FU or tegafur in the postoperative gastric cancer patients was already demonstrated, it is not uncertain about efficacy of combination therapy with PSK and TS-1 in gastric cancer. In this study, we compare efficacy and safety of postoperative adjuvant therapy using TS-1 or TS-1+PSK in the stage II or III gastric cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Tegafur-gimeracil-oteracil potassium (TS-1)The TS-1 group |
| 2 | Experimental | Drug: Tegafur-gimeracil-oteracil potassium (TS-1), Drug: Krestin (PSK)The TS-1+PSK Group |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patient who is pathologically confirmed as gastric cancer
- Patient who has received surgery with D2 or more lymph node dissection and whose final curability of surgical resection is grade A or B
- Patient whose final stage is II (except for T1), IIIA, or IIIB
- Patient without liver, peritoneal and distant metastasis, and who is negative in peritoneal cytological diagnosis
- Patient whose age at the registration is ranging between 20 and 80 years old
Key exclusion criteria (10 listed)
- Patient with metachronous or synchronous multicancer
- Patient who contraindicates to TS-1
- Patient who requires continuous use of flucytosine, phenytoin or warfarin potassium
- Patient who has experienced serious drug allergy over grade 3 in the past
- Patient with serious complications including paralysis of intestine, ileus, interstitial pneumonitis, fibroid lung, uncontrollable diabetes mellitus, heart insufficiency, renal insufficiency or hepatic insufficiency
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 (TS-1)Also: TS-180 mg/m2, PO from day 1 to day 28 of each 42 day cycle. Number of Cycles: 8 | Drug | 1, 2 |
| Krestin (PSK)Also: PSK3 g, PO from day 1 to day 336 | Drug | 2 |
Primary outcome
Relapse-free survival
Time frame: Five years after surgery
1 secondary outcome
Overall survival, quality of life, drug compliance, adverse events, serial changes of tumor markers
Time frame: Five years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2012.
- Background: PubMed 17978289Sakuramoto S, Sasako M, Yamaguchi T, Kinoshita T, Fujii M, Nashimoto A, Furukawa H, Nakajima T, Ohashi Y, Imamura H, Higashino M, Yamamura Y, Kurita A, Arai K; ACTS-GC Group. Adjuvant chemotherapy for gastric cancer with S-1, an oral fluoropyrimidine. N Engl J Med. 2007 Nov 1;357(18):1810-20. doi: 10.1056/NEJMoa072252.
- 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.
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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.
Masatsugu Kitamura, MD study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tegafur-gimeracil-oteracil potassium (TS-1) and Krestin (PSK) in people with Gastric Cancer, run by Tokyo Metropolitan Oncology Group at 1 site in Japan.
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 14 inclusion and 10 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 22 Mar 2012. 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 phase mean?
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?
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?
Relapse-free survival (time frame: Five years after surgery). 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 NCT00687843, which also lists 2 linked publications.
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 22 Mar 2012.