Sequential Paclitaxel Chemotherapy and Radiotherapy as 1st Line Treatment for Elderly Esophageal Squamous Cell Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Sequential Paclitaxel Chemotherapy and Radiotherapy as First Line Treatment for Elderly Metastatic Esophageal Squamous Cell Cancer:: a Phase II Single Center Prospective Clinical Trial

Conditions
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Esophageal Squamous Cell Cancer, Elderly Patients

Intervention / Treatment
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* Other: Sequential chemotherapy （paclitaxel 80mg/m2 d1,d8) and radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sequential treatment<br>paclitaxel treatment and radiotherapy | Other: Sequential chemotherapy （paclitaxel 80mg/m2 d1,d8) and radiotherapy<br>* Sequential paclitaxel chemotherapy and radiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival | 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 | 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 |