- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02016287
Sequential Paclitaxel Chemotherapy and Radiotherapy as 1st Line Treatment for Elderly Esophageal Squamous Cell Cancer
December 13, 2013 updated by: Shen Lin
Sequential Paclitaxel Chemotherapy and Radiotherapy as First Line Treatment for Elderly Metastatic Esophageal Squamous Cell Cancer:: a Phase II Single Center Prospective Clinical Trial
Elderly patients with metastatic esophageal squamous cell carcinomas have poor prognosis and majority of them were intolerable to combined chemotherapy in China.
In the investigators phase II clinical trial proceeded before, the paclitaxel treatment 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 elderly metastatic esophageal carcinoma to observe the efficacy and safety of the combination.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zhihao Lu, MD
- Phone Number: 86-10-88196561
- Email: pppeirain@126.com
Study Contact Backup
- Name: Lin Shen, MD
- Phone Number: 86-10-88196561
- Email: lin100@medmail.com.cn
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100142
- Recruiting
- Peking university cancer hospital
-
Contact:
- Zhihao Lu, MD
- Phone Number: 86-10-88196561
- Email: pppeirain@126.com
-
Contact:
- Lin Shen, MD
- Phone Number: 86-10-88196561
- Email: lin100@medmail.com.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
69 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Having signed informed consent Age more than 69 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
- Life expectancy of ≥ 3 month
- WBC > 3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet > 100,000/mm3, Hb > 9g/dl(within 14 days before enrollment),ALT and AST < 1.5 times ULN (≤5 times ULN in patients with liver metastases),Bilirubin level < 1.0 times ULN,Serum AKP < 2.5 times ULN,Serum creatinine < 1.0 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
Exclusion Criteria:
- 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
- Other previous malignancy within 5 year, except non-melanoma skin cancer
- Mentally abnormal or disable cognition,including CNS metastasis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: sequential treatment
paclitaxel treatment and radiotherapy
|
Sequential paclitaxel chemotherapy and radiotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
progression free survival
Time Frame: 1 year
|
the follow-up visit of PFS will be performed every 2 cycles
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall survival
Time Frame: 2 years
|
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
|
2 years
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
disease control rate
Time Frame: 1 year
|
1 year
|
quality of life
Time Frame: 2 years
|
2 years
|
adverse events
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lin Shen, MD, Peking Universtiy Cancer Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2013
Primary Completion (Anticipated)
December 1, 2015
Study Completion (Anticipated)
July 1, 2016
Study Registration Dates
First Submitted
December 7, 2013
First Submitted That Met QC Criteria
December 13, 2013
First Posted (Estimate)
December 19, 2013
Study Record Updates
Last Update Posted (Estimate)
December 19, 2013
Last Update Submitted That Met QC Criteria
December 13, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Esophageal Neoplasms
- Carcinoma, Squamous Cell
- Esophageal Squamous Cell Carcinoma
- Neoplasms, Squamous Cell
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
Other Study ID Numbers
- CGOG7002 (Registry Identifier: CGOG)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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