Surgically-Created Resection CavityPhase 2NCT01756183
Exploratory Study on the S-1 + Paclitaxel Chemotherapy for Unresectable Gastric Cancer
A Phase 2 study testing S-1 + Paclitaxel Chemotherapy in people with Surgically-Created Resection Cavity and Drug Safety, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
Exploratory the S-1 + Paclitaxel Chemotherapy for Creating the Operation Chance in the Patients with Unresectable Gastric Cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Surgically-Created Resection Cavity, Drug Safety
- What is being tested?
- S-1 + Paclitaxel Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Sep 2011to Dec 2016
- 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
- -Unresectable gastric cancer as proven histologically (AJCC, Version 7) under any following condition: Unable radical excision due to the local metastasis or invasion Metastasis to the lymph node beside the abdominal aorta Non-extensive metastasis to liver (not more than three metastatic foci of radical excision)
- Definitely diagnosed as above stage of stomach cancer before the operation via CT or MRI, ultrasonic endoscopy and blood tumor antigen test, or through the laparoscopy if necessary
- Untreated (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy)
- ECOG (Eastern Cooperative Oncology Group) : 0~2
- Age: 18~75 years old
- Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function). For example: WBC>4.0×109/L, NEU >1.5×109/L, PLT>100×109/L, BIL<1.5 times of upper limit of normal reference value, ALT and AST<2.5 times of upper limit of normal reference value, and CRE<1.2mg/dl
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- Good cardiac function before the recruitment, no seizure of myocardial infarction in past half year, and controllable hypertension and other coronary heart diseases
- Not concomitant with other uncontrollable benign diseases before the recruitment (e.g. the infection in the lung, kidney and liver)
- Not participating in other study projects before and during the treatment
- Signed the Informed Consent Form
Who cannot join
- Not conforming to above inclusion criteria
- Distal metastasis to lung, brain and bone (except the liver)
- Ever operation on the stomach
- Operation intolerance due to other systemic basic diseases
- Ever administered other drugs (including TCM drugs) before the recruitment, or no guarantee of progress according to the study requirement after the recruitment
- Allergy to the drugs in this protocol
- Pregnant or lactating women
- Women at childbearing age and of pregnancy desire during the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
xiangdong Cheng, MD, +86 571 88122516, abdsurg@hotmail.com
xiangdong Cheng, MD
About this study
Official title: Exploratory Study on the S-1 + Paclitaxel Chemotherapy for Creating the Operation Chance in the Patients With Unresectable Gastric Cancer
Exploratory the S-1 + Paclitaxel Chemotherapy for Creating the Operation Chance in the Patients with Unresectable Gastric Cancer
Read the detailed description
To assess the effectiveness and safety of S-1 + Paclitaxel for the peri-operative chemotherapy in Chinese patients with unresectable gastric cancer, so as to further find out the optimal protocol for the peri-operative chemotherapy in the patients with gastric cancer.
- Conditions
- Surgically-Created Resection Cavity, Drug Safety
- Being tested
- S-1 + Paclitaxel Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1 + Paclitaxel ChemotherapyDrug
Dose of S-1: 60mg bid，Twice daily (after the breakfast and supper) for two weeks, and then suspend for one week.
Dose of Paclitaxel: 150 mg/m2, iv, 3h, at D1
| Study group | Role | What they receive |
|---|---|---|
| S-1 + Paclitaxel Chemotherapy | Experimental | S-1: 60mg twice daily (after the breakfast and supper) for two weeks, and then suspend for one week.
Paclitaxel: 150 mg/m2, iv, 3h, at D1 Receives: Drug: S-1 + Paclitaxel Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
radical resection rate
radical resection rate
Measured: 3 months
Secondary outcomes (3)
Adverse Events
Number and degree of Adverse Events
Measured: 6 months
reaction rate
the reaction rate of chemotherapy
Measured: 2 months
overall survival time
the overall survival time
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2012 (estimated)
- Study startSep 2011
- Primary completionSep 2013 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgically-Created Resection CavityStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- xiangdong Cheng, MD, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01756183
- Sponsor's protocol ID
- SPECIAL
- Status last verified
- Dec 2012
- First submitted
- 29 Nov 2012
- Last updated
- 25 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study on the S-1 + Paclitaxel Chemotherapy for Creating the Operation Chance in the Patients With Unresectable Gastric Cancer
- ClinicalTrials.gov ID
- NCT01756183
- Acronym / sponsor ID
- SPECIAL
- Conditions
- Surgically-Created Resection Cavity, Drug Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 25 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.
Exploratory the S-1 + Paclitaxel Chemotherapy for Creating the Operation Chance in the Patients with Unresectable Gastric Cancer
Detailed description
To assess the effectiveness and safety of S-1 + Paclitaxel for the peri-operative chemotherapy in Chinese patients with unresectable gastric cancer, so as to further find out the optimal protocol for the peri-operative chemotherapy in the patients with gastric cancer.
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 + Paclitaxel Chemotherapy | Experimental | Drug: S-1 + Paclitaxel ChemotherapyS-1: 60mg twice daily (after the breakfast and supper) for two weeks, and then suspend for one week. Paclitaxel: 150 mg/m2, iv, 3h, at D1 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- -Unresectable gastric cancer as proven histologically (AJCC, Version 7) under any following condition: Unable radical excision due to the local metastasis or invasion Metastasis to the lymph node beside the abdominal aorta Non-extensive metastasis to liver (not more than three metastatic foci of radical excision)
- Definitely diagnosed as above stage of stomach cancer before the operation via CT or MRI, ultrasonic endoscopy and blood tumor antigen test, or through the laparoscopy if necessary
- Untreated (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy)
- ECOG (Eastern Cooperative Oncology Group) : 0~2
- Age: 18~75 years old
Key exclusion criteria (8 listed)
- Not conforming to above inclusion criteria
- Distal metastasis to lung, brain and bone (except the liver)
- Ever operation on the stomach
- Operation intolerance due to other systemic basic diseases
- Ever administered other drugs (including TCM drugs) before the recruitment, or no guarantee of progress according to the study requirement after the recruitment
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-1 + Paclitaxel ChemotherapyDose of S-1: 60mg bid，Twice daily (after the breakfast and supper) for two weeks, and then suspend for one week. Dose of Paclitaxel: 150 mg/m2, iv, 3h, at D1 | Drug | S-1 + Paclitaxel Chemotherapy |
Primary outcome
radical resection rate
Time frame: 3 months
radical resection rate
3 secondary outcomes
Adverse Events
Time frame: 6 months
reaction rate
Time frame: 2 months
overall survival time
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 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.
xiangdong Cheng, MD principal investigator
Zhejiang Cancer Hospital
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 + Paclitaxel Chemotherapy in people with Surgically-Created Resection Cavity and Drug Safety, run by Zhejiang Cancer Hospital 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 10 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 25 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 xiangdong Cheng, MD (+86 571 88122516, abdsurg@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
radical resection rate (time frame: 3 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 25 Dec 2012.