Simultaneous Modulated Accelerated Boost Versus Standard Dose Radiotherapy in Esophageal Cancer

• Status: Unknown status
• Trial end date: 2021-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chuangzhen Chen

Criteria

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.