Simultaneous Modulated Accelerated Boost Versus Standard Dose Radiotherapy in Esophageal Cancer

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

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.

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.