Simultaneous Modulated Accelerated Boost Versus Standard Dose Radiotherapy in Esophageal Cancer

Last updated: February 3, 2024
Sponsor: Chuangzhen Chen
Overall Status: Active - Not Recruiting

Phase

3

Condition

Esophageal Disorders

Esophageal Cancer

Digestive System Neoplasms

Treatment

Standard dose radiotherapy

PF

Radiotherapy with simultaneous modulated accelerated boost

Clinical Study ID

NCT02556762
SUMC-EC-002
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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.

Study Design

Total Participants: 202
Treatment Group(s): 3
Primary Treatment: Standard dose radiotherapy
Phase: 3
Study Start date:
August 01, 2015
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Cancer Hospital, Shantou University Medical College

    Shantou, Guangdong 515031
    China

    Site Not Available

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