Gastric CancerPhase 2NCT01747707
Cisplatin,Docetaxel and S-1 for Advanced Gastric and Gastroesophageal Junction Cancer
A Phase 2 study testing Docetaxel, Cisplatin and S-1 in people with Gastric Cancer and Gastroesophageal Junction Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The combination of Cisplatin and S-1 (CS) achieved a response rate of approximately 45% with the PFS being around 6 months and overall survival time being 13 months in Japanese and Chinese gastric patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer, Gastroesophageal Junction Cancer
- What is being tested?
- Docetaxel, Cisplatin and S-1
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Sep 2012to May 2014
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed unresectable advanced gastric or gastroesophageal junction cancer;
- No previous chemotherapy and radiation for advanced disease except palliative radiation for a local pain control;
- At least one evaluable lesion per RECIST (Response Evaluation Criteria in Solid Tumors) 1.1;
- ECOG (Eastern Cooperative Oncology Group) performance status 0-1;
- Recovery from the toxicities of previous therapy;
- Adequate bone marrow and organ function. Hb≥8 G/L; Absolute neutrophil ≥ 2.0 G/L; PLT ≥100 G/L ;ALT/AST ≤1.5 ULN or ≤5ULN with liver metastases; TBIL ≤1.5 ULN; Cr≤1.0 ULN;
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- Life expectancy ≥3 months;
- For men and women of childbearing potential, agree on taking effective contraceptive method of birth control from the signed informed consent until 3 months after the last study drug administration;
- Signed informed consent.
Who cannot join
- Pathology type other than adenocarcinoma,such as squamous cell carcinoma;
- Previous treatment with taxanes, cisplatin or S-1;
- Relapse within 6 months after the end of adjuvant chemotherapy;
- Known brain metastases;
- Complete or incomplete intestinal obstruction or uncontrolled gastrointestinal bleeding;
- Known deficiency of DPD enzyme;
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- Kown HIV infecton or drug addiction;
- Any acute or chronic medical or psychiatric condition that would make the patient inappropriate for entry into this trial in the judgement of investigators;
- Myocardial infarction within 6 months prior to the entry of this trial;
- Known history of allergic reaction to taxanes and platinum;
- Pregnant or breast feeding women.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital & Institute, Chinese Academy of Medical Sciences
Beijing, 10021
Yongkun Sun, M.D, 8610-87788145, hsunyk@tom.com
About this study
Official title: Phase II Clinical Trial of Cisplatin,Docetaxel and S-1 as First Line Chemotherapy for Advanced Gastric and Gastroesophageal Junction Cancer
The combination of Cisplatin and S-1 (CS) achieved a response rate of approximately 45% with the PFS being around 6 months and overall survival time being 13 months in Japanese and Chinese gastric patients. It remains unclear whether the addition of docetaxel to CS would further enhance the efficacy as it dose in DCF(docetaxel, cisplatin and 5-fluorouracil). This is a single center, phase II clinical trial to evaluate the efficacy of docetaxel, cisplatin and S-1 (DCS) as first line chemotherapy for patients with advanced gastric and gastroesophageal junction cancer.
Read the detailed description
This is a single arm trial. All Patients will receive up to 6 cycles of triple chemotherapy with docetaxel, cisplatin and S-1. Given the severe toxicity of DCF regimen, here the total dose of docetaxel and cisplatin is both reduced to 60mg/m2. For patients with CR/PR/SD disease after 6 cycles of chemotherapy, maintenance therapy with S-1 are recommended. Antitumor activity will be evaluated every two cycles according to RECIST1.1.
- Conditions
- Gastric Cancer, Gastroesophageal Junction Cancer
- Keywords
- gastric cancer, gastroesophageal junction cancer, chemotherapy, docetaxel, cisplatin, S-1
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| docetaxel, cisplatin and S-1 (DCS) | Experimental | All patients receive the combination therapy of docetaxel, cisplatin and S-1 for a maximum of 6 cycles. Docetaxel 60mg/m2 IV infusion over 1 hour on d1; Cisplatin 30mg/m2 IV infusion on d1,2; S-1 40mg orally twice a day for patients with the body surface area (BSA) less than 1.25m2, 50mg twice a day with the BSA between 1.25 and 1.5m2, 60mg twice a day with the BSA over 1.5m2. Receives: Drug: Docetaxel; Drug: Cisplatin; Drug: S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival time (OS)
To determine the OS of DCS in patients with chemo-naive, advanced gastric or gastroesophageal junction cancer.
Measured: 14 months
Secondary outcomes (2)
Progression free survival (PFS)
To determine the PFS of DCS in patients with chemo-naive, gastric or gastroesophageal junction cancer
Measured: 6 months
safety profile
To determine the tolerability of DCS in patients with chemo-naive, gastric or gastroesophageal junction cancer.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2013 (estimated)
- Study completionMay 2014 (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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aiping Zhou, Chinese Academy of Medical Sciences
- Investigators
- Aiping Zhou, M.D, Principal investigator, Cancer Hospital & Institute, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01747707
- Sponsor's protocol ID
- CH-GI-31
- Status last verified
- Dec 2012
- First submitted
- 10 Dec 2012
- Last updated
- 12 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial of Cisplatin,Docetaxel and S-1 as First Line Chemotherapy for Advanced Gastric and Gastroesophageal Junction Cancer
- ClinicalTrials.gov ID
- NCT01747707
- Acronym / sponsor ID
- CH-GI-31
- Conditions
- Gastric Cancer, Gastroesophageal Junction Cancer
- Keywords
- gastric cancer, gastroesophageal junction cancer, chemotherapy, docetaxel, cisplatin, S-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2013 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 12 Dec 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 combination of Cisplatin and S-1 (CS) achieved a response rate of approximately 45% with the PFS being around 6 months and overall survival time being 13 months in Japanese and Chinese gastric patients. It remains unclear whether the addition of docetaxel to CS would further enhance the efficacy as it dose in DCF(docetaxel, cisplatin and 5-fluorouracil). This is a single center, phase II clinical trial to evaluate the efficacy of docetaxel, cisplatin and S-1 (DCS) as first line chemotherapy for patients with advanced gastric and gastroesophageal junction cancer.
Detailed description
This is a single arm trial. All Patients will receive up to 6 cycles of triple chemotherapy with docetaxel, cisplatin and S-1. Given the severe toxicity of DCF regimen, here the total dose of docetaxel and cisplatin is both reduced to 60mg/m2. For patients with CR/PR/SD disease after 6 cycles of chemotherapy, maintenance therapy with S-1 are recommended. Antitumor activity will be evaluated every two cycles according to RECIST1.1.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| docetaxel, cisplatin and S-1 (DCS) | Experimental | Drug: Docetaxel, Drug: Cisplatin, Drug: S-1All patients receive the combination therapy of docetaxel, cisplatin and S-1 for a maximum of 6 cycles. Docetaxel 60mg/m2 IV infusion over 1 hour on d1; Cisplatin 30mg/m2 IV infusion on d1,2; S-1 40mg orally twice a day for patients with the body surface area (BSA) less than 1.25m2, 50mg twice a day with the BSA between 1.25 and 1.5m2, 60mg twice a day with the BSA over 1.5m2. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically or cytologically confirmed unresectable advanced gastric or gastroesophageal junction cancer;
- No previous chemotherapy and radiation for advanced disease except palliative radiation for a local pain control;
- At least one evaluable lesion per RECIST (Response Evaluation Criteria in Solid Tumors) 1.1;
- ECOG (Eastern Cooperative Oncology Group) performance status 0-1;
- Recovery from the toxicities of previous therapy;
Key exclusion criteria (11 listed)
- Pathology type other than adenocarcinoma,such as squamous cell carcinoma;
- Previous treatment with taxanes, cisplatin or S-1;
- Relapse within 6 months after the end of adjuvant chemotherapy;
- Known brain metastases;
- Complete or incomplete intestinal obstruction or uncontrolled gastrointestinal bleeding;
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 |
|---|---|---|
| DocetaxelAlso: taxotere | Drug | docetaxel, cisplatin and S-1 (DCS) |
| Cisplatin | Drug | docetaxel, cisplatin and S-1 (DCS) |
| S-1Also: TS-1 | Drug | docetaxel, cisplatin and S-1 (DCS) |
Primary outcome
overall survival time (OS)
Time frame: 14 months
To determine the OS of DCS in patients with chemo-naive, advanced gastric or gastroesophageal junction cancer.
2 secondary outcomes
Progression free survival (PFS)
Time frame: 6 months
safety profile
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2012.
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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.
Aiping Zhou, M.D principal investigator
Cancer Hospital & Institute, Chinese Academy of Medical Sciences
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 Docetaxel, Cisplatin and S-1 in people with Gastric Cancer and Gastroesophageal Junction Cancer, run by Chinese Academy of 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 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: status not confirmed, as of the sponsor's last update on 12 Dec 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aiping Zhou, M.D (8610-87788145, zhouap1825@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival time (OS) (time frame: 14 months). 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 12 Dec 2012.