Back to resultsSequential Paclitaxel Chemotherapy and Radiotherapy as 1st Line Treatment for Elderly Esophageal Squamous Cell Cancer
Primary Purpose
Esophageal Squamous Cell Cancer, Elderly Patients
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Sequential chemotherapy （paclitaxel 80mg/m2 d1,d8) and radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Squamous Cell Cancer
Eligibility Criteria
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
Sites / Locations
- Peking University Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
sequential treatment
Arm Description
paclitaxel treatment and radiotherapy
Outcomes
Primary Outcome Measures
progression free survival
the follow-up visit of PFS will be performed every 2 cycles
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02016287
Brief Title
Sequential Paclitaxel Chemotherapy and Radiotherapy as 1st Line Treatment for Elderly Esophageal Squamous Cell Cancer
Official Title
Sequential Paclitaxel Chemotherapy and Radiotherapy as First Line Treatment for Elderly Metastatic Esophageal Squamous Cell Cancer:: a Phase II Single Center Prospective Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
July 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Shen Lin
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Cancer, Elderly Patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
sequential treatment
Arm Type
Experimental
Arm Description
paclitaxel treatment and radiotherapy
Intervention Type
Other
Intervention Name(s)
Sequential chemotherapy （paclitaxel 80mg/m2 d1,d8) and radiotherapy
Intervention Description
Sequential paclitaxel chemotherapy and radiotherapy
Primary Outcome Measure Information:
Title
progression free survival
Description
the follow-up visit of PFS will be performed every 2 cycles
Time Frame
1 year
Secondary Outcome Measure Information:
Title
overall survival
Description
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
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
disease control rate
Time Frame
1 year
Title
adverse events
Time Frame
2 years
Title
quality of life
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Shen, MD
Phone
86-10-88196561
Email
lin100@medmail.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Zhihao Lu, MD
Phone
86-10-88196561
Email
pppeirain@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin Shen, MD
Organizational Affiliation
Peking Universtiy Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Shen, MD
Phone
86-10-88196561
Email
lin100@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Zhihao Lu, MD
Phone
86-10-88196561
Email
pppeirain@126.com
First Name & Middle Initial & Last Name & Degree
Lin Shen, MD
12. IPD Sharing Statement
Learn more about this trial
Sequential Paclitaxel Chemotherapy and Radiotherapy as 1st Line Treatment for Elderly Esophageal Squamous Cell Cancer
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