Simultaneous Modulated Accelerated Boost Versus Standard Dose Radiotherapy in Esophageal Cancer

Study Overview
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Brief Summary
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This randomized phase III trial is to compare simultaneous modulated accelerated boost with standard dose radiotherapy given together with chemotherapy in treating patients with esophageal squamous cell carcinoma.

Official Title
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Phase III Randomized Controlled Trial of Definite Chemoradiotherapy in Patients With Esophageal Cancer: Simultaneous Modulated Accelerated Boost Versus Standard Dose Radiotherapy

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Radiation: Radiotherapy with simultaneous modulated accelerated boost
* Radiation: Standard dose radiotherapy
* Drug: PF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologic proof of primary squamous cell carcinoma of the esophagus. Primary disease at cervical, upper or middle thoracic esophagus T1-4, N any, M0 (except supraclavicular lymph node). Age≥18 & ≤75. ECOG score 0-2. Platelets ≥ 150,000, Hgb ≥ 10 gm%, ANC ≥ 1500, serum creatinine ≤ 1.5 mg/dl. Adequate liver function. Patients with prior malignancy are eligible if disease-free ≥ 5 years. No prior chest radiotherapy, systemic chemotherapy or major esophageal surgery. Signed study-specific informed consent form prior to study entry. Exclusion Criteria: Patients with tracheo-esophageal fistula. Patients with invasion into mucosa of trachea or major bronchi. Patients with uncontrolled serious medical or mental illnesses. Prior RT that would result in overlap of planned RT fields. Pregnancy or women of childbearing potential and men who are sexually active Women who are breastfeeding a baby.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: SMART boost<br>Radiotherapy with simultaneous modulated accelerated boost | Radiation: Radiotherapy with simultaneous modulated accelerated boost<br>* Radiotherapy: 66Gy/30F to the gross tumor and 50Gy/25 to subclinical diseases<br>* Other names: SIB;Drug: PF<br>* Chemotherapy: Cisplatin and 5fluorouracil<br>|
| Active Comparator: Standard dose RT<br>Standard dose radiotherapy | Radiation: Standard dose radiotherapy<br>* Radiotherapy: 50Gy/25F to both gross tumor and subclinical disease<br>Drug: PF<br>* Chemotherapy: Cisplatin and 5fluorouracil<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local-regional control |  | 2 years | 
| Distant metastasis-free survival |  | 2 years | 
| Disease-free survival |  | 2 years after randomization | 
| Acute and late toxicities using CTCAE v4.0 | The probabilities of grade ≥ 3 acute toxicities and 2-year late toxicities of esophagus and lungs. | 2 years | 
| Quality of life as assessed with FACT-E | FACT-E score | 2 years | 
| Quality of life as measured with EQ-5D | The score of EQ-5D questionnaire | 2 years | 
| Biomarkers |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal cancer, Simultaneous modulated accelerated boost, Standard dose radiotherapy, Chemotherapy, Survival