Esophageal Squamous Cell CarcinomaPhase 2NCT01854749
S1 Combined With Cisplatin in Treatment of Recurrence/Metastasis of ESCC Open-label Single Center Phase II Clinical Study
A Phase 2 study testing S1 combined with cisplatin in people with Esophageal Squamous Cell Carcinoma, run by Fudan University at 1 site in China.
Trial summary
Assess the efficacy and safety of S1 combined with cisplatin in treatment of recurrence/metastasis of ESCC Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- S1 combined with cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteChina
- Study dates
- Nov 2011to Dec 2015
- 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
- Joined the study voluntarily and signed informed consent form;
- Age 18-75
- .Presence of at least one index lesion measurable by CT scan or MRI
- recurrence/metastasis of Esophageal carcinoma or gastroesophageal cancer confirmed by pathology
- No radiotherapy, chemotherapy or other treatments prior to enrollment
- PS ECOG 0-1
Show all 10Show fewer
- Life expectancy of more than 3 months
- ANC≥2×109/L，PLT≥100×109/L，Hb≥90g/L
- Cr≤1.0×UNL
- TBIL≤1.25×UNL； ALT/AST≤2.5×UNL，with hepatic metastases ALT/AST≤5.0×UNL；AKP≤2.5×UNL
Who cannot join
- there is radical cure of the cancer
- uncontrolled chronic diarrhea and esophageal obstruction
- Neurological or mental abnormalities Influence of cognitive ability include central nervous system metastases
- Severe complication(s), e.g.,uncontrolled active infection,myocardial infarction,hypertension,arrhythmia,stenocardia
- Patient who has metastasis except cured skin basal cell carcinoma and carcinoma in situ of cervix
- accept other antitumor therapy •Female patients during their pregnant and lactation period, or patients without contraception
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer hospital Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Assess the efficacy and safety of S1 combined with cisplatin in treatment of recurrence/metastasis of ESCC
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- S1 combined with cisplatin
- Keywords
- ESCC
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S1 combined with cisplatinDrug
| Study group | Role | What they receive |
|---|---|---|
| S1 combined with cisplatin | Experimental | Not described Receives: Drug: S1 combined with cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Measured: from the first cycle of treatment (day one) to two month after the last cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2013 (estimated)
- Study startNov 2011
- Primary completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Fudan 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang Jian Hua, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01854749
- Sponsor's protocol ID
- S1- ESCC -CJH
- Status last verified
- Feb 2016
- First submitted
- 10 May 2013
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- S1 Combined With Cisplatin in Treatment of Recurrence/Metastasis of ESCC Open-label Single Center Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT01854749
- Acronym / sponsor ID
- S1- ESCC -CJH
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- ESCC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2015 (actual)
- First posted
- 16 May 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.
Assess the efficacy and safety of S1 combined with cisplatin in treatment of recurrence/metastasis of ESCC
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| S1 combined with cisplatin | Experimental | Drug: S1 combined with cisplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Joined the study voluntarily and signed informed consent form;
- Age 18-75
- .Presence of at least one index lesion measurable by CT scan or MRI
- recurrence/metastasis of Esophageal carcinoma or gastroesophageal cancer confirmed by pathology
- No radiotherapy, chemotherapy or other treatments prior to enrollment
Key exclusion criteria (6 listed)
- there is radical cure of the cancer
- accept other antitumor therapy •Female patients during their pregnant and lactation period, or patients without contraception
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 |
|---|---|---|
| S1 combined with cisplatin | Drug | S1 combined with cisplatin |
Primary outcome
Progression Free Survival
Time frame: from the first cycle of treatment (day one) to two month after the last cycle
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 23 Feb 2016.
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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 2 study testing S1 combined with cisplatin in people with Esophageal Squamous Cell Carcinoma, run by Fudan University 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 6 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 23 Feb 2016. 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?
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?
Progression Free Survival (time frame: from the first cycle of treatment (day one) to two month after the last cycle). 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 23 Feb 2016.