Randomized study of high-dose (60-64 Gy) versus standard-dose (50 Gy) Intensity-Modulated Radiation Therapy (IMRT) for the trimodality therapy of patients with squamous cell carcinoma of thoracic esophagus.

Phase 3

Recruiting

• Conditions: squamous cell carcinoma of thoracic esophagus; Esophageal Neoplasms; Radiotherapy; Radiation oncology; IMRT

• Registration Number: TCTR20170704001
• Lead Sponsor: Ratchadaphiseksomphot Endowment Fund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-04
• Study Completion: 2022-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

1.Confirmed histopathologic diagnosis of primary (non-recurrent) squamous cell carcinoma of thoracic esophagus
2.T2-T4b, N0-3, M0 (Appendix 2)
3.Age 18-75 years
4.Karnofsky performance scale 60-100
5.Acceptable laboratory investigation: WBC ≥ 3,000/μl, platelets ≥ 100,000/μl; serum creatinine ≤ 1.6 mg/dl or creatinine clearance ≥ 60 ml/min using the following formula:
Estimated Creatinine Clearance = [140 †age (y)] x Body weight (kg) x 0.85 if female/ [72 x Serum creatinine (mg/dl)]
6.Weight loss < 20%
7.Dysphagia in any grade
8.Signed study-specific informed consent form prior to study entry

Exclusion Criteria

1.Prior chest radiotherapy; prior systemic chemotherapy; prior major esophageal surgery.
2.Patients with multiple primary carcinomas of the esophagus.
3.Patients with TE fistula or metastatic disease (other than supraclavicular or celiac nodes).
4.Pregnant or lactating women or men unable or unwilling to practice contraception.
5.Patients with an uncontrolled diabetes (the blood sugar level was more than 180 mg/dL at the time of the PET scan), heart disease, hypertension, other uncontrolled serious medical or mental illnesses.
6.Patients who are unable to comprehend the study requirements or who are not likely to comply with the study parameters.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Median survival time None months

Secondary Outcome Measures

Name	Time	Method
Progression free survival 1,2,3,4,5 years months,Tumor response rate 3 months RECIST criteria version 1.1,Acute and late toxicities 3 months CTCAE version 4.03,Pattern of recurrence 1,2,3,4,5 years Crude calculation,Dosimetric study None Dose volume histogram