Esophageal CancerPhase 3NCT01998347
Paclitaxel Liposome and Cisplatin as First-line Chemotherapy in Patients With Metastatic Esophageal Cancer
A Phase 3 study testing Paclitaxel liposome, Cisplatin and 5-fluorouracil in people with Esophageal Cancer, run by Shantou University Medical College at 1 site in China.
Trial summary
There are no standard chemotherapy regimens for metastatic esophageal cancer. Cisplatin plus 5-fluorouracil is widely used as first-line treatment with a response rate ranged from 30% to 40%. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Paclitaxel liposome, Cisplatin and 5-fluorouracil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Nov 2013to Dec 2017
- 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 confirmed metastatic esophageal tumors with no previous treatment for advanced disease or recurrent disease after previous treatment for at least one year.
- At least one measurable lesion according to the RECIST1.1 (Response Evaluation Criteria in Solid Tumors RECIST Version 1.1) criteria. Minimum indicator lesion size: > 10 mm measured by spiral CT or >20mm measured by conventional techniques.
- Patients aged between 18 and 70 years, inclusive, at the time of acquisition of informed consent
- Patients with performance status(ECOG) 0 to 1.
- Abnormal hematologic values (WBC ≥ 3.0 x 109/L, Hemoglobin ≥ 10.0g/dl, platelet count ≥ 100 x 109/L)
- Creatinine clearance ≥ 60 ml/min, Serum creatinine ≤ 1.5mg/dl
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- Serum bilirubin ≤ 1.5mg/dl. ALT(Alanine transaminase ), AST(Aspartate Transaminase) ≤ 2.5 x upper normal limit (or ≤ 2.5 x upper normal limit in the case of liver metastases)
- Life expectancy ≥ 3 months
- Patients who have given written informed consent to participate in this study
Who cannot join
- Patients with active multiple cancers; or even if the multiple cancers are metachronous, have a disease-free period of less than 5 years (but excluding cancer in situ and skin cancer)
- Serious, uncontrolled, concurrent infection(s) or illness(es)
- Patients with no serious concurrent complications (such as heart disease, Intestinal pneumonia)
- Patients with brain metastasis
- Patients receiving continuous administration of steroids
- Patients who have experienced serious drug allergy in the past
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- Patients with retention of body fluid(pleural effusion, ascites, pericardial effusion) necessitating treatment
- Patients who are pregnant and lactating or hope to become pregnant during the study period
- Patients with prior Taxane treatment (Paclitaxel)
- Others, patients judged by the investigator or coinvestigator to be inappropriate as subject
Trial locations and contacts
1 site in 1 country.
China1 site
Department of medical oncology,Cancer hospital of Shantou University Medical colledge
Shantou, Guangdong, 515031
About this study
Official title: Paclitaxel Liposome and Cisplatin as First-line Chemotherapy in Patients With Metastatic Esophageal Cancer: an Open-label, Randomised Phase 3 Trial.
There are no standard chemotherapy regimens for metastatic esophageal cancer. Cisplatin plus 5-fluorouracil is widely used as first-line treatment with a response rate ranged from 30% to 40%. Combination of paclitaxel and cisplatin has been investigated in small size clinical trial, producing promising outcome.Liposome capsuled paclitaxel has been proved to be as effective as paclitaxel.The usefulness of the the regimen of paclitaxel liposome with cisplatin is evaluated by median survival time, progression free survival,and response rate.
- Conditions
- Esophageal Cancer
- Being tested
- Paclitaxel liposome, Cisplatin, 5-fluorouracil
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel liposomeDrug
CisplatinDrug
5-fluorouracilDrug
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel liposome and Cisplatin | Experimental | Drug: paclitaxel liposome 175mg/m2, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles:up to 6 cycles.
Drug: cisplatin 37.5 mg/m2, IV (in the vein) on day 1~2 of each 21 day cycle. Number of Cycles: up to 6 cycles. Receives: Drug: Paclitaxel liposome; Drug: Cisplatin |
| Cisplatin plus 5-fluorouracil | Active comparator | Cisplatin:
37.5 mg/m2, IV (in the vein) on day 1-2 of each 21 day cycle. Number of Cycles: up to 6 cycles.
5-fluorouracil: 200mg/m2, CIV (continuous intravenous infusion) on day 1~5 of each 21 day cycle. Number of Cycles: up to 6 cycles. Receives: Drug: Cisplatin; Drug: 5-fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
median overall survival
Measured: one year
Secondary outcomes (1)
median progression free survival
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2017 (estimated)
Why it stopped: slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shantou University Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Yingcheng, Shantou University Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01998347
- Sponsor's protocol ID
- CSMECS 01
- Other IDs
- LYC01
- Status last verified
- Nov 2015
- First submitted
- 17 Nov 2013
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paclitaxel Liposome and Cisplatin as First-line Chemotherapy in Patients With Metastatic Esophageal Cancer: an Open-label, Randomised Phase 3 Trial.
- ClinicalTrials.gov ID
- NCT01998347
- Acronym / sponsor ID
- CSMECS 01
- Conditions
- Esophageal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: slow enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shantou University Medical CollegeUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2017 (estimated)
- First posted
- 28 Nov 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.
There are no standard chemotherapy regimens for metastatic esophageal cancer. Cisplatin plus 5-fluorouracil is widely used as first-line treatment with a response rate ranged from 30% to 40%. Combination of paclitaxel and cisplatin has been investigated in small size clinical trial, producing promising outcome.Liposome capsuled paclitaxel has been proved to be as effective as paclitaxel.The usefulness of the the regimen of paclitaxel liposome with cisplatin is evaluated by median survival time, progression free survival,and response rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel liposome and Cisplatin | Experimental | Drug: Paclitaxel liposome, Drug: CisplatinDrug: paclitaxel liposome 175mg/m2, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles:up to 6 cycles. Drug: cisplatin 37.5 mg/m2, IV (in the vein) on day 1~2 of each 21 day cycle. Number of Cycles: up to 6 cycles. |
| Cisplatin plus 5-fluorouracil | Active comparator | Drug: Cisplatin, Drug: 5-fluorouracilCisplatin: 37.5 mg/m2, IV (in the vein) on day 1-2 of each 21 day cycle. Number of Cycles: up to 6 cycles. 5-fluorouracil: 200mg/m2, CIV (continuous intravenous infusion) on day 1~5 of each 21 day cycle. Number of Cycles: up to 6 cycles. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed metastatic esophageal tumors with no previous treatment for advanced disease or recurrent disease after previous treatment for at least one year.
- At least one measurable lesion according to the RECIST1.1 (Response Evaluation Criteria in Solid Tumors RECIST Version 1.1) criteria. Minimum indicator lesion size: > 10 mm measured by spiral CT or >20mm measured by conventional techniques.
- Patients aged between 18 and 70 years, inclusive, at the time of acquisition of informed consent
- Patients with performance status(ECOG) 0 to 1.
- Abnormal hematologic values (WBC ≥ 3.0 x 109/L, Hemoglobin ≥ 10.0g/dl, platelet count ≥ 100 x 109/L)
Key exclusion criteria (10 listed)
- Patients with active multiple cancers; or even if the multiple cancers are metachronous, have a disease-free period of less than 5 years (but excluding cancer in situ and skin cancer)
- Serious, uncontrolled, concurrent infection(s) or illness(es)
- Patients with no serious concurrent complications (such as heart disease, Intestinal pneumonia)
- Patients with brain metastasis
- Patients receiving continuous administration of steroids
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 |
|---|---|---|
| Paclitaxel liposome | Drug | Paclitaxel liposome and Cisplatin |
| Cisplatin | Drug | Cisplatin plus 5-fluorouracil, Paclitaxel liposome and Cisplatin |
| 5-fluorouracil | Drug | Cisplatin plus 5-fluorouracil |
Primary outcome
median overall survival
Time frame: one year
1 secondary outcome
median progression free survival
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
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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 3 study testing Paclitaxel liposome, Cisplatin and 5-fluorouracil in people with Esophageal Cancer, run by Shantou University Medical College 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 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: withdrawn, as of the sponsor's last update on 20 Nov 2015. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
median overall survival (time frame: one year). 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 20 Nov 2015.