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Multi-institutional study: Phase II/III randomized controlled trial between intensity-modulated radiotherapy (IMRT) vs intensity-modulated proton therapy (IMPT) for esophageal cancer

Multi-institutional study: Phase II/III randomized controlled trial between intensity-modulated radiotherapy (IMRT) vs intensity-modulated proton therapy (IMPT) for esophageal cancer

Status
Unknown
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20200310006
Enrollment
230
Registered
2020-03-10
Start date
2021-09-06
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

patients with stage II-IV squamous cell carcinoma of esophagus esophageal cancer proton therapy x-ray therapy randomized

Interventions

Intensity&#45
modulated x&#45
ray therapy 64 Gy/32 fractions&#44
daily&#44
Monday&#45
Friday with Chemotherapy (concurrent +/&#45
adjuvant) options: &#45
cisplatin 75 mg/m2 + 5&#45
fluorouracil 1&#44
000 mg/m2/day for 4 days&#44
every 4 weeks &#45
carboplatin AUC 2 mg/ml/min + paclitaxel 50 mg/m2&#44
every 1 week &#45
cisplatin 80&#45
100 mg/m2 every 3 weeks หรือ cisplatin 40 mg/m2 every 1 week (cervical esophageal cancer only) with surgery if resectable after chemoradiation,Intensity&#45
modulated proton therapy 64 Gy/32 fractions&#44

Sponsors

Thailand Science research and Innovation Fund Chulalongkorn University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Biopsy proven stage II-IV squamous cell carcinoma of esophagus 2.Age 20-70 3.Performance status (ECOG) 0-2 4.Weight loss </= 10% from baseline 5.Normal liver and renal function

Exclusion criteria

Exclusion criteria: 1.Distant metastasis 2.Evidence of tracheoesophageal or esophagobronchial fistula 3.Prior or simultaneous malignancies within the past two years (other than skin cancers) 4.Pregnant women, women planning to become pregnant and women that are nursing 5.Uncontrolled intercurrent illness 6.Prior radiation treatment to the chest or mediastinum with overlapping field

Design outcomes

Primary

MeasureTime frame
progression-free survival 2 years time from diagnosis to any recurrence or death/Kaplan-Meier (KM) method—

Secondary

MeasureTime frame
Locoregional control 2 years evidence of persistence or recurrence within esophagus or regional lymph nodes/clinical+imagings,Distant metastasis free survival 2 years time from diagnosis to distant metastasis or nonregional lymph nodes,Overall survival 2 years time from diagnosis to death due to any causes/KM method,Toxicities during treatment CTCAE criteria/clinical+patient-reported outcomes,cost utility 1 year EQ-D5/QALY—

Countries

Thailand

Contacts

Public ContactChawalit Lertbutsayanukul

Division of Radiation Oncology, Department of Radiology, Faculty of Medicine, Chulalongkorn Universi

wisutiyano@gmail.com0910090879

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026