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
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
ChinaSite Not Available

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