IMRT With Carboplatin Versus IMRT With Carboplatin and Fluorouracil for Eldly Esophageal Cancer Patients

Study Overview
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Brief Summary
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An open, single-center, randomized controlled phase II clinical trial to compare the efficacy and safety of conformal intensity modulated radiation therapy (IMRT) combined with carboplatin and IMRT combined with carboplatin and 5-FU in elderly patients with locally advanced esophageal squamous cell carcinoma at high risk of chemotherapy

Detailed Description
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Esophageal cancer is one of the most common malignant tumors in China.To compare the efficacy and safety of conformal intensity modulated radiation therapy (IMRT) combined with carboplatin and IMRT combined with carboplatin and 5-FU in elderly patients with locally advanced esophageal squamous cell carcinoma at high risk of chemotherapy.This trial is an open, single-center, randomized controlled phase II clinical trial.

Official Title
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IMRT Combined With Carboplatin Versus IMRT Combined With Carboplatin and Fluorouracil in the Treatment of Locally Advanced Esophageal Cancer in Elderly Patients With High Risk of Chemotherapy: a Randomized Controlled Clinical Study

Conditions
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Esophageal Cancer, Radiotherapy Side Effect

Intervention / Treatment
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* Drug: Fluorouracil
* Radiation: Intensity modulated radiation therapy
* Drug: carboplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age (> 65 years) Histologically confirmed esophageal squamous cell carcinoma, the 8th edition of AJCC stage T3-4NxM0 or TxN1-3M0, without surgical indications after consultation by surgeons. PS score < 2, Chemotherapy risk score is medium and high risk No radical thoracic surgery/chemotherapy/radiotherapy/targeted therapy has been performed in the past. Diseases measurable according to RECIST standards Hematological examination requires Hb (>90g/L), ANC (>2.0 *109/L) and platelet (>100 *109/L). Serum albumin (>3.0g/dL) Serum creatinine < 1.25 times normal upper limit (UNL), or creatinine clearance rate (>60 ml/min). Total bilirubin < upper limit of normal value Total bilirubin < the upper limit of normal value, AST (SGOT) and ALT (SGPT) < 2.5 times the upper limit of normal value, ALP < 2.5 times the upper limit of normal value (ULN) If exploratory surgery is performed, the patient will recover at least 2 weeks after operation. Exclusion Criteria: Pregnant or lactating women. Patients with fertility without adequate contraceptive measures. Anaphylaxis to 5FU and carboplatin is known. Anaphylaxis known to exist with any drug in the study Other malignant tumors have occurred in the past five years, except cervical carcinoma in situ or non-melanoma skin cancer, which has been properly treated. Discovery of esophageal fistula or risk of esophageal bleeding before treatment Distant organ metastasis is known Symptomatic peripheral neuropathy, according to NCIC-CTC criteria (> grade 2). Other serious diseases or medical conditions: Myocardial infarction (in the past six months), severe unstable angina pectoris and congestive heart failure have occurred. Severe complications (including intestinal paralysis, intestinal obstruction, interstitial pneumonia, pulmonary fibrosis, severe respiratory dysfunction of COPD, cardiac dysfunction of pulmonary heart disease, uncontrolled diabetes mellitus, renal insufficiency and cirrhosis of liver, etc.) Gastrointestinal bleeding requires frequent blood transfusion. It is known to carry human immunodeficiency virus (HIV) or AIDS. Suffering from mental illness The known neuropathy is of grade 2 or higher severity.

Ages Eligible for Study
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Minimum Age: 65 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMRT combined with carboplatin<br>Intensity modulated radiation therapy 50-60Gy, Carboplatin (AUC 2), QW1, intravenous drip, repeat for 4 weeks | Radiation: Intensity modulated radiation therapy<br>* Radiotherapy for 5-6 weeks，50-60Gy<br>* Other names: IMRT;Drug: carboplatin<br>* Carboplatin (AUC 2), QW1, intravenous drip, repeat for 4 weeks<br>|
| Placebo Comparator: IMRT combined with carboplatin and fluorouracil<br>Intensity modulated radiation therapy 50-60Gy, Carboplatin (AUC 2), QW1, intravenous drip; Fluorouracil 1.33g/body surface QW1, continuous intravenous infusion for 72 hours, repeated for 4 weeks | Drug: Fluorouracil<br>* 1.33g/body surface QW1, continuous intravenous infusion for 72 hours, repeated for 4 weeks<br>* Other names: 5-FU;Radiation: Intensity modulated radiation therapy<br>* Radiotherapy for 5-6 weeks，50-60Gy<br>* Other names: IMRT;Drug: carboplatin<br>* Carboplatin (AUC 2), QW1, intravenous drip, repeat for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall objective response rate | The proportion of partial and complete remission of tumors | up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of toxic and side effects above 3 degrees | The Incidence of toxic and side effects above 3 degrees in overall patients | up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal Cancer, radiotherapy, chemotherapy, Carboplatin