Health TrialsbyHealthPanel

Hypofractionated Adjuvant Radiotherapy for Thymic Epithelial Tumors

ConditionsThymus NeoplasmsThymic Epithelial TumorThymomaThymic Carcinoma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Taiwan University Hospital

About this trial

This is a multi-center, open-label, single-arm, prospective interventional study evaluating hypofractionated adjuvant radiotherapy (HART) after radical thymothymectomy in patients with thymic epithelial tumors. The study estimates 5-year local control and prospectively characterizes acute and late treatment-related adverse events, quality of life, cardiopulmonary function, and patterns of failure. Photon therapy and proton therapy are both protocol-acceptable modalities and are selected by shared decision-making rather than randomization.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Thymic epithelial tumor, including thymoma or thymic carcinoma, confirmed by pathology.

Received radical thymothymectomy.

Masaoka-Koga stage I to III disease with an indication for postoperative radiotherapy.

Age >= 18 years.

Disqualifiers

Prior radiotherapy to the thorax.

Severe active comorbidities that, in the judgment of the investigator, make the patient inappropriate for study entry, interfere with safety or adverse event assessment, or limit compliance with study requirements, including: uncontrolled active infection requiring intravenous antibiotics at registration; transmural myocardial infarction <= 6 months prior to registration; unstable angina or congestive heart failure requiring hospitalization <= 6 months prior to registration; life-threatening uncontrolled clinically significant cardiac arrhythmias; hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at registration; uncontrolled psychiatric disorder.

Planned receipt of another investigational treatment during radiotherapy.

Planned concurrent chemotherapy during radiotherapy. Prior induction or neoadjuvant chemotherapy, or planned sequential adjuvant chemotherapy after adjuvant radiotherapy, is allowed.

Trial design

Design model

Single group

Treatments tested in this trial

  • Hypofractionated Adjuvant Proton Therapy

    Radiation

    Base regimen of 40 Gy (RBE) in 15 fractions or 42.5 Gy (RBE) in 16 fractions. Optional tumor-bed boost of 10 Gy (RBE) in 4 fractions or 16 Gy (RBE) in 6 fractions for R2 macroscopic residual disease may be delivered at investigator discretion if normal tissue constraints are met. Radiation is delivered using Proton pencil-beam scanning IMPT.

  • Hypofractionated Adjuvant Photon Radiation Therapy

    Radiation

    Base regimen of 40 Gy in 15 fractions or 42.5 Gy in 16 fractions. Optional tumor-bed boost of 10 Gy in 4 fractions or 16 Gy in 6 fractions for R2 macroscopic residual disease may be delivered at investigator discretion if normal tissue constraints are met. Treatment is delivered by Photon IMRT/VMAT/RapidArc techniques.

Treatment groups

69 Participants
are divided into 1 treatment group
Group A: Hypofractionated Adjuvant Radiation TherapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

5-year local control rate

Local control is defined as absence of radiologically or pathologically confirmed tumor recurrence within the original tumor bed or adjacent mediastinal region.

Time frame
5 years after start of radiotherapy

Secondary outcomes

1

Progression-free survival

Time from start of radiotherapy to first documented disease progression, including local, regional, or distant progression, or death from any cause.

Time frame
Up to 5 years after start of radiotherapy
2

Overall survival

Time from start of radiotherapy to death from any cause.

Time frame
Up to 5 years after start of radiotherapy
3

Treatment-related adverse events

Acute and late treatment-related adverse events graded using CTCAE version 6.0, including grade 2 or higher and grade 3 or higher events, with attention to radiation pneumonitis, esophagitis, and cardiac events.

Time frame
From treatment start through 5 years of follow-up
4

Health-related quality of life

EORTC QLQ-C30 Taiwanese Mandarin version scores, transformed to a 0 to 100 scale according to EORTC guidelines.

Time frame
Baseline and 1, 3, 6, 12, 18, and 24 months after radiotherapy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Taiwan University Hospital

Lead sponsor

National Taiwan University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: