Gastric CancerNCT01650766
Study of S1 Efficacy and Toxicity as Second-line Treatment on Inoperable or Advanced Gastric Cancers
An observational study of Gastric Cancer, run by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences at 1 site in China.
Trial summary
The primary purpose of the study is to investigate the correlation between the efficacy and toxicity of S-1 on gastric cancers and the expression of thymidylate synthase (TS), dihydropyrimidine dehydrogenase (DPD) and orotate phosphoribosyltransferase(OPRT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Feb 2012to Oct 2012
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with inoperable or advanced gastric cancers
Who may be able to join
- Histologically confirmed, inoperable or advanced gastric cancer patients who received at most 1st line treatment
- Aged 18 years or older
- KPS performance status of ≥ 70.
- Anticipated life expectancy of ≥ 3 months.
- Adequate organ function, including bone marrow, kidney and liver.
- ANC ≥ 1.5×109/L and hemoglobin ≥ 8g/dL and platelet count ≥ 100×109/L
Show all 9Show fewer
- Serum total bilirubin ≤ 1.5 x ULN, Serum ALT and AST ≤ 2.5 x ULN (Serum ALT and AST ≤ 5 x ULN, if liver metastases are present)
- Serum creatinine ≤ 1.5 x ULN and CLcr > 60 ml/min
- Written informed consent can be obtained prior to their participation in the trial.
Who cannot join
- History of severe drug allergy , or an allergy to any components of S1
- Subjects who have received chemotherapy, immunotherapy or radiotherapy within two weeks
- Alimentary tract hemorrhage, diarrhea or aphagosis at the present stage
- Subjects with uncontrolled CNS metastasis or epilepsia or severe psychiatric disorders.
- Subjects who are regarded to be unsuitable for this trial by the investigator.
- Subjects who are participating in other clinical trials
- Subjects with ascites draining or severe infection
- Pregnant or breast-feeding women
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
307 Hospital of PLA
Beijing, Beijing Municipality, 100071
Xu Jianming, M.D., +861051168358, jmxu2003@yahoo.com
About this study
The primary purpose of the study is to investigate the correlation between the efficacy and toxicity of S-1 on gastric cancers and the expression of thymidylate synthase (TS), dihydropyrimidine dehydrogenase (DPD) and orotate phosphoribosyltransferase(OPRT).
Read the detailed description
TS, DPD and OPRT are the key enzymes on the metabolic pathway of 5-Fu. We will retrospectively analyze the clinicopathological features of the patients who have suffered an inoperative or recurrent gastric cancers and administrated with S-1, such as the overall survival (OS), progressive-free survival (PFS), Lauren's classification and toxicity of S1, etc. We will divide the patients into several subgroups according to the parameters above, and then investigate the correlation between the parameters and the expression of TS, DPD and OPRT.
All of the analysis is retrospective, there is no different treatment operation once the subject enrolled in this study.
- Conditions
- Gastric Cancer
- Medical subject headings
- Stomach Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study startFeb 2012
- Study completionOct 2012 (estimated)
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu jianming, The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
- Investigators
- Xu Jianming, M.D., Principal investigator, The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01650766
- Sponsor's protocol ID
- AGC-307PLAH-XJM
- Status last verified
- Jul 2012
- First submitted
- 19 Jan 2012
- Last updated
- 26 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of S1 Efficacy and Toxicity as Second-line Treatment on Inoperable or Advanced Gastric Cancers
- ClinicalTrials.gov ID
- NCT01650766
- Acronym / sponsor ID
- AGC-307PLAH-XJM
- Conditions
- Gastric Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of the Chinese Academy of Military Medical SciencesUniversity, hospital or other
- Study start
- Feb 2012
- Study completion
- Oct 2012 (estimated)
- First posted
- 26 Jul 2012 (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.
The primary purpose of the study is to investigate the correlation between the efficacy and toxicity of S-1 on gastric cancers and the expression of thymidylate synthase (TS), dihydropyrimidine dehydrogenase (DPD) and orotate phosphoribosyltransferase(OPRT).
Detailed description
TS, DPD and OPRT are the key enzymes on the metabolic pathway of 5-Fu. We will retrospectively analyze the clinicopathological features of the patients who have suffered an inoperative or recurrent gastric cancers and administrated with S-1, such as the overall survival (OS), progressive-free survival (PFS), Lauren's classification and toxicity of S1, etc. We will divide the patients into several subgroups according to the parameters above, and then investigate the correlation between the parameters and the expression of TS, DPD and OPRT.
All of the analysis is retrospective, there is no different treatment operation once the subject enrolled in this study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with inoperable or advanced gastric cancers
Key inclusion criteria (9 listed)
- Histologically confirmed, inoperable or advanced gastric cancer patients who received at most 1st line treatment
- Aged 18 years or older
- KPS performance status of ≥ 70.
- Anticipated life expectancy of ≥ 3 months.
- Adequate organ function, including bone marrow, kidney and liver.
Key exclusion criteria (8 listed)
- History of severe drug allergy , or an allergy to any components of S1
- Subjects who have received chemotherapy, immunotherapy or radiotherapy within two weeks
- Alimentary tract hemorrhage, diarrhea or aphagosis at the present stage
- Subjects with uncontrolled CNS metastasis or epilepsia or severe psychiatric disorders.
- Subjects who are regarded to be unsuitable for this trial by the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2012.
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.
Xu Jianming, M.D. principal investigator
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences at 1 site in China.
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 8 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 26 Jul 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 China. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
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 26 Jul 2012.