Gastric CancerPhase 1NCT01269255
A Trial of Induction Chemotherapy and Chemoradiotherapy With TS-1 and Cisplatin (SP) as First-line Treatment in Patients With High Risk Advanced Gastric Cancer
A Phase 1 study testing TS-1 with Cisplatin in people with Gastric Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
A Phase I trial of Induction chemotherapy and Chemoradiotherapy with TS-1 and Cisplatin (SP) as first-line treatment in patients with high risk advanced gastric cancer. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- TS-1 with Cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2009to Jan 2012
- Phase
- Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically documented gastric adenocarcinoma
- Patients must have unresectable disease or high-risk advanced tumor: borrmann type IV, large borrmann type III (>8cm),locally extensive nodal disease (bulky N),locally advanced (T4) tumors,esophageal invasion
- Age: 20 to 75
- ECOG PS: 0 or 1
- Patients with adequate organ function : Absolute neutrophil count > 1.5 x 109 / L, Platelet count > 100 x 109 / L, Hemoglobin > 9 g/dL (by transfusion permitted), Calculated creatinine clearance > 60 ml/min, Serum total bilirubin < 1.5 times upper normal limit (UNL), Serum alanine transaminase (ALT) < 3 times UNL
- Signed informed consent
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- Sexually active patients, in conjunction with their partner, must practice birth control during therapy. Female patients in child-bearing age must have negative pregnancy test.
- No other malignancies within the past 5 years except for curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix
- No prior or concurrent significant medical conditions, including any of the following: Cerebrovascular disease within the past year/ Cardiovascular disease; myocardial infarction within the past year, uncontrolled hypertension while receiving chronic medication, unstable angina, New York Heart Association class II-IV congestive heart failure, serious cardiac arrhythmia requiring medication/ Major trauma, major surgery or open biopsy within the 28 days Serious nonhealing wound, ulcer, or bone fracture/ Evidence of bleeding diathesis or coagulopathy/ Recent history of any active gastrointestinal inflammatory condition
- No lack of physical integrity of the upper GI tract, malabsorption syndrome, or inability to take oral medication
- No bleeding from primary tumor or gastrointestinal stenosis
- sufficient oral intake
- No prior surgery for gastric cancer except for endoscopic membrane resection (EMR)
- No known peripheral neuropathy ≥ 1
- No prior chemotherapy
- No prior radiotherapy
Who cannot join
- Other tumor type than adenocarcinoma
- Metastasis to the sites out of abdomen (liver or other hematogenous metastasis)
- Patients with definite ascites in pre-operative abdomen CT
- documented inoperable peritoneal seeding disease determined by exploratory laparotomy
- Past or concurrent history of neoplasm other than gastric cancer, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
- Pregnant or lactating women, women of childbearing potential not employing adequate contraception
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- Other serious illness or medical conditions: History of significant neurologic or psychiatric disorders including dementia or seizures/ Active uncontrolled infection/ Severe hypercalcemia of above 12 mg/dL uncontrolled with bisphosphonates/ Other serious underlying medical conditions which could impair the ability of the patient to participate in the study
- Concurrent treatment with corticosteroids (or equivalent) except as use for the prophylactic medication regimen, treatment of acute hypersensitivity reactions, or unless chronic treatment (initiated > 6 months prior to study entry) at low dose (<20 mg methyl prednisolone or equivalent)
- Concomitant or with a 4-week period administration of any other experimental drug under investigation
- Concomitant chemotherapy, hormonal therapy, or immunotherapy
- Prior palliative surgery (open and closure, passage operation)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Trial of Induction Chemotherapy and Chemoradiotherapy With TS-1 and Cisplatin (SP) as First-line Treatment in Patients With High Risk Advanced Gastric Cancer
A Phase I trial of Induction chemotherapy and Chemoradiotherapy with TS-1 and Cisplatin (SP) as first-line treatment in patients with high risk advanced gastric cancer. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation therapy was effectively used in esophageal cancer, laryngeal cancer and rectal cancer, but gastric cancer are rarely studied in Korea. There is an increasing interest in preoperative radiotherapy in effort to improve survival and increase pathologic complete response in patients with gastric cancer. Chemoradiotherapy may be the best modality in the neoadjuvant setting for high-risk advanced tumors, such as type IV or large type III, N3/bulky N2 metastasis, or locally advanced tumors.
- Conditions
- Gastric Cancer
- Being tested
- TS-1 with Cisplatin
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TS-1 with CisplatinDrug
SP CCRT(= TS-1 with Cisplatin concurrent radiation therapy)
- Step 1: Chemotherapy; TS-1/CDDP #2 cycles
- Step 2: Chemoradiotherapy; CCRT with weekly TS-1/CDDP
- Step 3: Surgery therapy
| Study group | Role | What they receive |
|---|---|---|
| Combination group | Experimental | Not described Receives: Drug: TS-1 with Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum tolerated dose
Measured: about 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study startDec 2009
- Primary completionJan 2012
- Study completionJan 2012
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 Yonsei UniversityThe 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 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269255
- Sponsor's protocol ID
- 4-2009-0555
- Status last verified
- Jun 2013
- First submitted
- 3 Jan 2011
- Last updated
- 4 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Induction Chemotherapy and Chemoradiotherapy With TS-1 and Cisplatin (SP) as First-line Treatment in Patients With High Risk Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT01269255
- Acronym / sponsor ID
- 4-2009-0555
- Conditions
- Gastric Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 4 Jan 2011 (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.
A Phase I trial of Induction chemotherapy and Chemoradiotherapy with TS-1 and Cisplatin (SP) as first-line treatment in patients with high risk advanced gastric cancer. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation therapy was effectively used in esophageal cancer, laryngeal cancer and rectal cancer, but gastric cancer are rarely studied in Korea. There is an increasing interest in preoperative radiotherapy in effort to improve survival and increase pathologic complete response in patients with gastric cancer. Chemoradiotherapy may be the best modality in the neoadjuvant setting for high-risk advanced tumors, such as type IV or large type III, N3/bulky N2 metastasis, or locally advanced tumors.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination group | Experimental | Drug: TS-1 with Cisplatin |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically or cytologically documented gastric adenocarcinoma
- Patients must have unresectable disease or high-risk advanced tumor: borrmann type IV, large borrmann type III (>8cm),locally extensive nodal disease (bulky N),locally advanced (T4) tumors,esophageal invasion
- Age: 20 to 75
- ECOG PS: 0 or 1
- Patients with adequate organ function : Absolute neutrophil count > 1.5 x 109 / L, Platelet count > 100 x 109 / L, Hemoglobin > 9 g/dL (by transfusion permitted), Calculated creatinine clearance > 60 ml/min, Serum total bilirubin < 1.5 times upper normal limit (UNL), Serum alanine transaminase (ALT) < 3 times UNL
Key exclusion criteria (11 listed)
- Other tumor type than adenocarcinoma
- Metastasis to the sites out of abdomen (liver or other hematogenous metastasis)
- Patients with definite ascites in pre-operative abdomen CT
- documented inoperable peritoneal seeding disease determined by exploratory laparotomy
- Past or concurrent history of neoplasm other than gastric cancer, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
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 |
|---|---|---|
| TS-1 with CisplatinSP CCRT(= TS-1 with Cisplatin concurrent radiation therapy) * Step 1: Chemotherapy; TS-1/CDDP #2 cycles * Step 2: Chemoradiotherapy; CCRT with weekly TS-1/CDDP * Step 3: Surgery therapy | Drug | Combination group |
Primary outcome
maximum tolerated dose
Time frame: about 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TS-1 with Cisplatin in people with 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 16 inclusion and 11 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 4 Jun 2013. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
maximum tolerated dose (time frame: about 7 weeks). 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 Jun 2013.