FindTrial
Sign In

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.

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.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20170704001
Enrollment
172
Registered
2017-07-04
Start date
2015-04-21
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

squamous cell carcinoma of thoracic esophagus Esophageal Neoplasms Radiotherapy Radiation oncology IMRT

Interventions

Dose per fraction will be equally applied to gross primary tumor&#44
gross nodes and to elective nodes throughout an initial plan (2 Gy x 25 fractions&#44
total dose of 50 Gy). For high dose radiation&#44
the initial plan will be followed by a boost plan to gross primary tumor to a total dose of 60&#45
64 Gy in 30&#45
32 fractions (i.e. shrinking field technique),Dose per fraction will be equally applied to gross primary tumor&#44
total dose of 50 Gy). No boost will be added.
Experimental Radiation,Active Comparator Radiation
High&#45
dose radiation,Standard&#45
dose radiation

Sponsors

Ratchadaphiseksomphot Endowment Fund
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Confirmed histopathologic diagnosis of primary (non&#45;recurrent) squamous cell carcinoma of thoracic esophagus 2. T2&#45;T4b&#44; N0&#45;3&#44; M0 (Appendix 2) 3. Age 18&#45;75 years 4. Karnofsky performance scale 60&#45;100 5. Acceptable laboratory investigation: WBC ≥ 3&#44;000/μl&#44; platelets ≥ 100&#44;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&#45;specific informed consent form prior to study entry

Exclusion criteria

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)&#44; heart disease&#44; hypertension&#44; 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.

Design outcomes

Primary

MeasureTime frame
Median survival time None months—

Secondary

MeasureTime frame
Progression free survival 1&#44;2&#44;3&#44;4&#44;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&#44;2&#44;3&#44;4&#44;5 years Crude calculation,Dosimetric study None Dose volume histogram—

Countries

Thailand

Contacts

Public ContactChawalit Lertbutsayanukul

Faculty of Medicine&#44; Chulalongkorn University

wisutiyano@gmail.com022564334

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026