Simultaneous Modulated Accelerated Boost Versus Standard Dose Radiotherapy in Esophageal Cancer (SUMC-EC-002)

Chuangzhen Chen

Status and phase: Active, not recruiting; Phase 3

Conditions: Esophageal Cancer

Treatments: Radiation: Radiotherapy with simultaneous modulated accelerated boost; Drug: PF; Radiation: Standard dose radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02556762

SUMC-EC-002

Details and patient eligibility

About

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.

Enrollment: 202 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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202 participants in 2 patient groups

SMART boost

Experimental group

Description:

Radiotherapy with simultaneous modulated accelerated boost

Treatment:

Radiation: Radiotherapy with simultaneous modulated accelerated boost

Drug: PF

Standard dose RT

Active Comparator group

Description:

Standard dose radiotherapy

Treatment:

Radiation: Standard dose radiotherapy

Drug: PF