Esophageal Squamous Cell CarcinomaPhase 3NCT02677597
Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal Squamous Cell Carcinoma
A Phase 3 study testing Cisplatin Combined With S-1 and Cisplatin Combined With Paclitaxel in people with Esophageal Squamous Cell Carcinoma, run by Fudan University at 1 site in China.
Trial summary
Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal Squamous Cell Carcinoma Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- Cisplatin Combined With S-1 and Cisplatin Combined With Paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Jan 2019
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven primary thoracic esophageal squamous cell carcinoma
- Not suitable for surgery or radio or chemical therapy
- Presence of at least one index lesion measurable by CT scan or MRI radiation therapy ended at least 4 weeks, but part of the radiation does not as a measurable lesions
- 18~70 years
- PS:0-1
- Life expectancy of ≥ 3 months
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- WBC≥3.5×109/L,ANC≥1.5×109/L, PLT≥100×109/L, Hb≥100g/L
- TB ≤ 1.5UNL, ALT/AST ≤ 2.5×UNL
- Scr≥60 mL/min
- Normal electrocardiogram (ecg)
- Can normal oral drugs
- Signed written informed consent
Who cannot join
- Breast-feeding or pregnant women, no effective contraception if risk of conception exists
- Chronic diarrhea, enteritis, intestine obstruction which are not under control
- Esophageal obstruction cannot eat liquid completely, esophagus have deep ulcer perforation or hematemesis; Esophageal cancer common complications such as anastomotic leakage, serious lung complications, etc.
- A second primary tumor (except skin basal cell carcinoma)
- The original serious heart disease, including: higher risk of congestive heart failure, unable to control arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and resistant hypertension
- With uncontrol nerve, mental illness or mental disorders, compliance is poor, can't cooperate with accounts and response to treatment; Primary brain tumors or - CNS metastases illness did not get a control, has obvious cranial hypertension or nerve mental symptoms
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- With bleeding tendency
- Has inherited bleeding evidence of physical or blood coagulation disorder
- With clear chemotherapy drug allergy
- Other researchers believe that patients should not participate in this testing
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer hospital Fudan University
Shanghai, Shanghai Municipality, 200032
Chang J hua, PD, 13916619284, changjianhua@163.com
Chang J hua, PD
About this study
Official title: An Open, Multicenter, Randomized Phase III Clinical Study on Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal Squamous Cell Carcinoma
Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal Squamous Cell Carcinoma
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Cisplatin Combined With S-1, Cisplatin Combined With Paclitaxel
- 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.
Cisplatin Combined With S-1Drug
Cisplatin Combined With PaclitaxelDrug
| Study group | Role | What they receive |
|---|---|---|
| Cisplatin Combined With S-1 | Experimental | Cisplatin 75mg/m2 ivgtt d1 S-1 BSA<1.5 50mg bid，BSA≥1.5 60mg bid po d1-14 Receives: Drug: Cisplatin Combined With S-1 |
| Cisplatin Combined With Paclitaxel | Experimental | Cisplatin 75mg/m2 ivgtt d1 Paclitaxel 175mg/m2 d1 ivgtt 3h Receives: Drug: Cisplatin Combined With Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Measured: Since the date of random to disease progression or any cause of death，the average time is 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 268 participants (estimated)
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
- NCT02677597
- Sponsor's protocol ID
- CISPEC study
- Status last verified
- Feb 2016
- First submitted
- 5 Feb 2016
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Multicenter, Randomized Phase III Clinical Study on Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT02677597
- Acronym / sponsor ID
- CISPEC study
- Conditions
- Esophageal Squamous Cell Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 268 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 9 Feb 2016 (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.
Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal Squamous Cell Carcinoma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cisplatin Combined With S-1 | Experimental | Drug: Cisplatin Combined With S-1Cisplatin 75mg/m2 ivgtt d1 S-1 BSA<1.5 50mg bid，BSA≥1.5 60mg bid po d1-14 |
| Cisplatin Combined With Paclitaxel | Experimental | Drug: Cisplatin Combined With PaclitaxelCisplatin 75mg/m2 ivgtt d1 Paclitaxel 175mg/m2 d1 ivgtt 3h |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically proven primary thoracic esophageal squamous cell carcinoma
- Not suitable for surgery or radio or chemical therapy
- Presence of at least one index lesion measurable by CT scan or MRI radiation therapy ended at least 4 weeks, but part of the radiation does not as a measurable lesions
- 18~70 years
- PS:0-1
Key exclusion criteria (10 listed)
- Breast-feeding or pregnant women, no effective contraception if risk of conception exists
- Chronic diarrhea, enteritis, intestine obstruction which are not under control
- Esophageal obstruction cannot eat liquid completely, esophagus have deep ulcer perforation or hematemesis; Esophageal cancer common complications such as anastomotic leakage, serious lung complications, etc.
- A second primary tumor (except skin basal cell carcinoma)
- The original serious heart disease, including: higher risk of congestive heart failure, unable to control arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and resistant hypertension
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 |
|---|---|---|
| Cisplatin Combined With S-1 | Drug | Cisplatin Combined With S-1 |
| Cisplatin Combined With Paclitaxel | Drug | Cisplatin Combined With Paclitaxel |
Primary outcome
PFS
Time frame: Since the date of random to disease progression or any cause of death，the average time is 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2016.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cisplatin Combined With S-1 and Cisplatin Combined With Paclitaxel 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 12 inclusion and 10 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 9 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Chang J Hua, PD (13916619284, changjianhua@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: Since the date of random to disease progression or any cause of death，the average time is 2 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 9 Feb 2016.