Raltitrexed Concurrent With Radiotherapy for Elderly Chinese Patients With Squamous Cell Carcinoma of Esophagus

Study Overview
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Brief Summary
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Concurrent chemoradiotherapy is one of the curative options for esophageal squamous cell carcinoma. We evaluated the efficacy and toxicity of raltitrexed with concurrent radiotherapy in elderly patients with esophageal cancer.

Official Title
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Raltitrexed Concurrent With Radiotherapy for Elderly Chinese Patients With Squamous Cell Carcinoma of Esophagus: A Phase-II Study

Conditions
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Esophagus Squamous Cell Carcinoma

Intervention / Treatment
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* Drug: raltitrexed


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological or cytologic diagnosis of esophageal carcinoma. ECOG performance status 0-1. Age:70-85 years. Joined the study voluntarily and signed informed consent form Patients must not have received any prior anticancer therapy. Stage IIa-Ⅳa(AJCC 2002). Target lesions can be measured according to RECIST criteria. No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥9 g/dL, WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L, platelet count ≥100x 109/L, TBIL<1.5 x ULN, ALT and AST ≦ 2.5 x ULN, creatinine ≦ 1.5 x ULN. Exclusion Criteria: Multiple carcinomas of the esophagus. Biopsy-proven invasion of the tracheobronchial tree or tracheoesophageal fistula. Metastatic disease (M1b). A primary tumor that extended to within 2 cm of the gastroesophageal junction. Prior chemotherapy, prior thoracic radiation, surgical resection of the primary tumor. history of a second malignancy other than nonmelanoma skin cancer.

Ages Eligible for Study
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Minimum Age: 70 Years
Maximum Age: 85 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment group<br> | Drug: raltitrexed<br>* Raltitrexed 2.6mg/m2 was administered on d1、d22<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival(OS) | From the date of randomization until the date of death | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival (DFS) | From the date of randomization to the date of first observation of disease progression, or relapse, or death due to any cause | 3 years | 
| treatment-related toxicities | Toxicities were graded according to the National Cancer Institute Common Toxicity Criteria (NCICTC), version 3.0 | From the date of randomization until six months after treatment completion | 
| Quality of life(QOL) | QOL is respectively evaluated at randomization and 1 month, 3 month, 6 month and yearly after treatment among patients by using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ-C30) | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal neoplasma, adjuvant therapy, raltitrexed, radiotherapy