Gastric CancerPhase 2NCT01824004
Postoperative Chemoradiotherapy With S-1 in Gastric Cancer
A Phase 2 study testing S-1 in people with Gastric Cancer, run by Chonnam National University Hospital at 1 site in South Korea.
Trial summary
This study was conducted to evaluate the clinical outcomes and toxicities of adjuvant treatment including S-1/cisplatin chemotherapy followed by S-1 based CRT. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- S-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2009to Jun 2012
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Histologically proven gastric adenocarcinoma which is complete resected
- ECOG performance status of 1 or lower
- Adequate bone marrow function
- absolute neutrophil count [ANC] ≥1,500µL, and platelets ≥100,000/µL
- Adequate kidney function (serum creatinine < 1.5 mg/dL)
- Adequate liver function (serum total bilirubin < 2 times the upper normal limit (UNL) serum transaminases levels <2 times UNL
- No prior chemotherapy
Who cannot join
- Other tumor type than adenocarcinoma
- Evidence of distant metastasis
- Past or concurrent history of neoplasm except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
- Uncontrolled infection
- Unstable cardiac disease despite treatment, myocardial infarction within months prior to study entry
- History of significant neurologic or psychiatric disorders including dementia or seizures
Show all 9Show fewer
- Other serious underlying medical conditions which could impair the ability of the patient to participate in the study
- Symptoms of gastrointestinal obstruction
- concomitant drug medication: The following drugs cause drug interaction with S-1.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chonnam National University Hwasun Hospital
Hwasun-Eup, Jeollanam-do, 519-809
About this study
Official title: A Phase II Study of Adjuvant S-1/Cisplatin Chemotherapy Followed by S-1-based Chemoradiotherapy in Advanced Gastric Cancer
This study was conducted to evaluate the clinical outcomes and toxicities of adjuvant treatment including S-1/cisplatin chemotherapy followed by S-1 based CRT.
Read the detailed description
Surgery is the only possible curative treatment of gastric cancer. However, the high recurrence rate makes gastric cancer a disease difficult to cure by surgery alone. Despite the benefit of CRT on local recurrence, the distant recurrence is the leading pattern of failure. We hypothesized that gastric cancer outcome could be improved using a more effective chemotherapy regimen. This study was conducted to evaluate the clinical outcomes and toxicity of adjuvant treatment including S-1/cisplatin chemotherapy followed by S-1 based CRT.
- Conditions
- Gastric Cancer
- Being tested
- S-1
- Keywords
- Gastric cancer, Adjuvant, Chemoradiotherapy, S-1, 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.
S-1Drug
Also called TS-1
| Study group | Role | What they receive |
|---|---|---|
| S-1,chemoradiotherapy, adjuvant treatment | Experimental | Pts with radically D2 resected adenocarcinoma of the stomach or GEJ in AJCC stage Ib-IV (M0) were eligible for this study. Pts were treated with S-1 (40-60 mg depending on BSA) b.i.d. for 3 wks, and cisplatin (60 mg/m²) iv on day 1, followed by a 2-wk rest period, within a 5-wk cycle. Subsequently, radiotherapy (RT) started which consisted of 25 fractions of 1.8 Gy to a total dose of 45 Gy in 5 wks (5 fractions/wk). On RT days, S-1 (40-60 mg depending on BSA ) b.i.d., 5 days/wk was given. One month after the completion of RT, two 5-wk cycles of S-1/ciplatin chemotherapy were given. Receives: Drug: S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Measured: 3 years
Secondary outcomes (2)
Overall Survival
Measured: 3 years
Number of participants with adverse events as a measure of safety and tolerability
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startApr 2009
- Primary completionOct 2010
- Study completionJun 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.
- 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonnam National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang-Hee Cho, Chonnam National University Hospital
- Investigators
- Sang-Hee Cho, M.D.Ph.D., Principal investigator, CNUHH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824004
- Sponsor's protocol ID
- CNUHH-MO-03
- Other IDs
- CNUHH
- Status last verified
- Apr 2013
- First submitted
- 28 Mar 2013
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Adjuvant S-1/Cisplatin Chemotherapy Followed by S-1-based Chemoradiotherapy in Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT01824004
- Acronym / sponsor ID
- CNUHH-MO-03
- Conditions
- Gastric Cancer
- Keywords
- Gastric cancer, Adjuvant, Chemoradiotherapy, S-1, Cisplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Chonnam National University HospitalUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 4 Apr 2013 (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.
This study was conducted to evaluate the clinical outcomes and toxicities of adjuvant treatment including S-1/cisplatin chemotherapy followed by S-1 based CRT.
Detailed description
Surgery is the only possible curative treatment of gastric cancer. However, the high recurrence rate makes gastric cancer a disease difficult to cure by surgery alone. Despite the benefit of CRT on local recurrence, the distant recurrence is the leading pattern of failure. We hypothesized that gastric cancer outcome could be improved using a more effective chemotherapy regimen. This study was conducted to evaluate the clinical outcomes and toxicity of adjuvant treatment including S-1/cisplatin chemotherapy followed by S-1 based CRT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| S-1,chemoradiotherapy, adjuvant treatment | Experimental | Drug: S-1Pts with radically D2 resected adenocarcinoma of the stomach or GEJ in AJCC stage Ib-IV (M0) were eligible for this study. Pts were treated with S-1 (40-60 mg depending on BSA) b.i.d. for 3 wks, and cisplatin (60 mg/m²) iv on day 1, followed by a 2-wk rest period, within a 5-wk cycle. Subsequently, radiotherapy (RT) started which consisted of 25 fractions of 1.8 Gy to a total dose of 45 Gy in 5 wks (5 fractions/wk). On RT days, S-1 (40-60 mg depending on BSA ) b.i.d., 5 days/wk was given. One month after the completion of RT, two 5-wk cycles of S-1/ciplatin chemotherapy were given. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age > 18 years
- Histologically proven gastric adenocarcinoma which is complete resected
- ECOG performance status of 1 or lower
- Adequate bone marrow function
- Adequate kidney function (serum creatinine < 1.5 mg/dL)
Key exclusion criteria (9 listed)
- Other tumor type than adenocarcinoma
- Evidence of distant metastasis
- Past or concurrent history of neoplasm except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
- Uncontrolled infection
- Unstable cardiac disease despite treatment, myocardial infarction within months prior to study entry
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 |
|---|---|---|
| S-1Also: TS-1 | Drug | S-1,chemoradiotherapy, adjuvant treatment |
Primary outcome
Disease free survival
Time frame: 3 years
2 secondary outcomes
Overall Survival
Time frame: 3 years
Number of participants with adverse events as a measure of safety and tolerability
Time frame: 3 year
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 Apr 2013.
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
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
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.
Sang-Hee Cho, M.D.Ph.D. principal investigator
CNUHH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S-1 in people with Gastric Cancer, run by Chonnam National University Hospital 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 8 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: finished, as of the sponsor's last update on 4 Apr 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 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?
Disease free survival (time frame: 3 years). 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 Apr 2013.