Esophageal Squamous Cell CancerPhase 2NCT02016274
Sequential Paclitaxel Plus Cisplatin Chemotherapy and Radiotherapy as 1st Line Treatment for Esophageal Squamous Cell Cancer
A Phase 2 study testing Sequential chemotherapy (paclitaxel 175mg/m2 d1; cisplatin 37.5mg/m2 d1,d2) and radiotherapy in people with Esophageal Squamous Cell Cancer, run by Shen Lin at 1 site in China.
Trial summary
Metastatic esophageal squamous cell carcinomas have poor prognosis and majority of patients resistant to chemotherapy in China. In the investigators phase II clinical trial proceeded before, the combination of paclitaxel with cisplatin showed good tolerance and efficacy to esophageal squamous cell carcinomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Squamous Cell Cancer
- What is being tested?
- Sequential chemotherapy (paclitaxel 175mg/m2 d1; cisplatin 37.5mg/m2 d1,d2) and radiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- Dec 2013to Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having signed informed consent
- Age ≥18 years old
- Histologically confirmed esophageal squamous carcinoma,metastatic disease with primary tumor,no prior palliative chemotherapy; No prior radiotherapy except radiotherapy at non-target lesion of the study more than 3 months
- Sex is not limited
- Measurable disease according to the RECIST criteria(diameter of the lesion should be more than 10mm by spiral CT or MRI, more than 20mm by common CT, the date of image should be less than 15 days before enrollment)
- Karnofsky performance status ≥80
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- Life expectancy of ≥ 3 month
- WBC > 3,000/mm3, absolute neutrophil count ≥1500/mm3, platelet > 100,000/mm3, Hb > 9g/dl(within 14 days before enrollment),ALT and AST < 2.5 times ULN (≤5 times ULN in patients with liver metastases),Bilirubin level < 1.0 times ULN,Serum AKP < 2.5 times ULN,Serum creatinine < 1.5 times ULN
- No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever > 38℃；
- Normal ECG and heart function
- Fertile patients must use effective contraception
- Good compliance
Who cannot join
- Previous treatment of palliative chemotherapy
- Known hypersensitivity to Paclitaxel,Cisplatin
- Only with Brain or bone metastasis
- No measurable lesions, eg. pleural fluid and ascites
- Suffer from severe heart disease or disease with other important organs
- Chronic diarrhea or renal dysfunction
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- Pregnancy or lactation period
- Other previous malignancy within 5 year, except non-melanoma skin cancer Chronic diarrhea
- Mentally abnormal or disable cognition,including CNS metastasis
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142
Lin Shen, MD, 86-10-88196561, lin100@medmail.com.cn
Zhihao Lu, MD, 86-10-88196561, pppeirain@126.com
About this study
Official title: Sequential Paclitaxel Plus Cisplatin Chemotherapy and Radiotherapy as First Line Treatment for Metastatic Esophageal Squamous Cell Cancer:: a Phase II Single Center Prospective Clinical Trial
Metastatic esophageal squamous cell carcinomas have poor prognosis and majority of patients resistant to chemotherapy in China. In the investigators phase II clinical trial proceeded before, the combination of paclitaxel with cisplatin showed good tolerance and efficacy to esophageal squamous cell carcinomas. Radiotherapy has been indicated as a definitive treatment for unresectable or medically inoperable tumors in ESCC patients. However, not only the combination with chemotherapy, but also the boundaries of the clinical target volume (CTV) are not internationally defined. The investigators then initiated a prospective phase II clinical trial with sequential paclitaxel/cisplatin and radiotherapy as the 1st line treatment in metastatic esophageal carcinoma to observe the efficacy and safety of the combination.
- Conditions
- Esophageal Squamous Cell Cancer
- Being tested
- Sequential chemotherapy (paclitaxel 175mg/m2 d1; cisplatin 37.5mg/m2 d1,d2) and radiotherapy
- 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.
Sequential chemotherapy (paclitaxel 175mg/m2 d1; cisplatin 37.5mg/m2 d1,d2) and radiotherapyOther
Sequential paclitaxel/cisplatin chemotherapy and radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| sequential treatment | Experimental | paclitaxel/cisplatin treatment and radiotherapy Receives: Other: Sequential chemotherapy (paclitaxel 175mg/m2 d1; cisplatin 37.5mg/m2 d1,d2) and radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
the follow-up visit of PFS will be performed every 2 cycles
Measured: 1 year
Secondary outcomes (1)
overall survival
OS means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 3 months till death or lost
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2015 (estimated)
- Study completionJul 2016 (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 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shen Lin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shen Lin, Peking University
- Investigators
- Lin Shen, MD, Principal investigator, Peking Universtiy Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02016274
- Sponsor's protocol ID
- CGOG7001
- Other IDs
- CGOG7001
- Status last verified
- Dec 2013
- First submitted
- 7 Dec 2013
- Last updated
- 19 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Paclitaxel Plus Cisplatin Chemotherapy and Radiotherapy as First Line Treatment for Metastatic Esophageal Squamous Cell Cancer:: a Phase II Single Center Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT02016274
- Acronym / sponsor ID
- CGOG7001
- Conditions
- Esophageal Squamous Cell Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Shen LinUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 19 Dec 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.
Metastatic esophageal squamous cell carcinomas have poor prognosis and majority of patients resistant to chemotherapy in China. In the investigators phase II clinical trial proceeded before, the combination of paclitaxel with cisplatin showed good tolerance and efficacy to esophageal squamous cell carcinomas. Radiotherapy has been indicated as a definitive treatment for unresectable or medically inoperable tumors in ESCC patients. However, not only the combination with chemotherapy, but also the boundaries of the clinical target volume (CTV) are not internationally defined. The investigators then initiated a prospective phase II clinical trial with sequential paclitaxel/cisplatin and radiotherapy as the 1st line treatment in metastatic esophageal carcinoma to observe the efficacy and safety of the combination.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sequential treatment | Experimental | Other: Sequential chemotherapy (paclitaxel 175mg/m2 d1; cisplatin 37.5mg/m2 d1,d2) and radiotherapypaclitaxel/cisplatin treatment and radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Having signed informed consent
- Age ≥18 years old
- Histologically confirmed esophageal squamous carcinoma,metastatic disease with primary tumor,no prior palliative chemotherapy; No prior radiotherapy except radiotherapy at non-target lesion of the study more than 3 months
- Sex is not limited
- Measurable disease according to the RECIST criteria(diameter of the lesion should be more than 10mm by spiral CT or MRI, more than 20mm by common CT, the date of image should be less than 15 days before enrollment)
Key exclusion criteria (9 listed)
- Previous treatment of palliative chemotherapy
- Known hypersensitivity to Paclitaxel,Cisplatin
- Only with Brain or bone metastasis
- No measurable lesions, eg. pleural fluid and ascites
- Suffer from severe heart disease or disease with other important organs
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 |
|---|---|---|
| Sequential chemotherapy (paclitaxel 175mg/m2 d1; cisplatin 37.5mg/m2 d1,d2) and radiotherapySequential paclitaxel/cisplatin chemotherapy and radiotherapy | Other | sequential treatment |
Primary outcome
progression free survival
Time frame: 1 year
the follow-up visit of PFS will be performed every 2 cycles
1 secondary outcome
overall survival
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.
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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.
Lin Shen, MD principal investigator
Peking Universtiy 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 Sequential chemotherapy (paclitaxel 175mg/m2 d1; cisplatin 37.5mg/m2 d1,d2) and radiotherapy in people with Esophageal Squamous Cell Cancer, run by Shen Lin 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 9 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 19 Dec 2013. 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 Lin Shen, MD (86-10-88196561, lin100@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (time frame: 1 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 19 Dec 2013.