Actively Recruiting

All Genders
ID06950073

Curatively Intended Thoracic Reirradiation: An Observational Study of High-dose Reirradiation for Thoracic Tumours in a Multicentre Prospective Registration

Led by University of Aarhus · Updated on 2026-03-04

500

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating high-dose reirradiation (reRT) for patients with recurrent or new thoracic cancers, including lung cancer and solitary lung metastases. This multicentre prospective cohort study aims to collect detailed data on radiotherapy-related toxicity, loco-regional control, and overall survival to improve the safety and effectiveness of reRT. The study also seeks to establish guidelines for dose accumulation and organ protection to standardize treatment strategies. All patients eligible for reirradiation will receive radiotherapy following established dose limits, with no additional interventions as this is an observational registration study. The study involves collecting previous treatment data, including digital dose plans, and monitoring patients through regular thoracic CT scans and clinical assessments. Follow-up is conducted every three months for two years and then every six months up to five years, capturing toxicity levels and patient-reported outcomes. Participants will undergo thorough baseline assessments of prior treatments, comorbidities, and toxicity. Researchers will monitor adverse events using standardized criteria and evaluate quality of life and decision regret through validated questionnaires at baseline, three months, and annually. Data on survival, disease progression, and treatment compliance will also be collected, supporting individualized treatment decisions and enhancing understanding of reirradiation risks and benefits over a long-term period extending up to five years.

CONDITIONS

Brief Title

Curatively Intended Thoracic Reirradiation

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Radiotherapy of thoracic lesion(s) aiming for long-term local control, including locoregional lung cancer recurrence, new primary lung cancer, or solitary oligo metastasis
  • Previous thoracic radiotherapy as per ESTRO-EORTC consensus definition of reirradiation
  • Malignancy verified by biopsy or multidisciplinary conference decision if biopsy is unavailable
  • Available digital dose plans from prior radiotherapy treatments
  • Adequate lung function to tolerate radiotherapy as determined by treating physician
  • Ability to complete a radiotherapy course aimed at local control
  • ECOG Performance status between 0 and 2
  • Estimated life expectancy of at least 6 months
  • Age 18 years or older
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Uncontrolled other malignancies
  • Primary and reirradiation treatments planned quasi-simultaneously instead of independently
  • Pregnancy
  • Radiotherapy to a minimum clinical target volume mean dose below 45 Gy for small cell lung cancer or below 50 Gy for non-small cell lung cancer and oligometastatic lesions
  • Treatment schedule not following local protocols or treating physician's preference

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 5 years

Participants who undergo routine thoracic reirradiation are observed. Data on previous treatments, toxicity, and patient-reported outcomes are collected to understand the effects of high-dose reirradiation.

Clinical follow-up visits every 3 months for 2 years, then every 6 months until 5 years

Trial Site Locations

Total: 1 location

1

Aarhus University Hospital

Aarhus, Jutland, Denmark, 8200

Actively Recruiting

Loading map...

Research Team

S

Stine O Fredslund, MD, PhD

L

Lone Hofmann, Physicist

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

Similar Trials

Preoperative 3-D Virtual Resection Predicts Lung Function Af...

Non-small Cell Lung Cancer

Actively Recruiting

1 location

Toward Precision Radiotherapy: Physiological Modeling of Res...

Healthy Volunteers

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology.

N K Aaronson, S Ahmedzai, B Bergman...

https://pubmed.ncbi.nlm.nih.gov/8433390

Second re-irradiation: efficacy, dose and toxicity in patients who received three courses of radiotherapy with overlapping fields.

Huda Abusaris, Pascal R M Storchi, Rene P Brandwijk...

https://pubmed.ncbi.nlm.nih.gov/21497928

European Society for Radiotherapy and Oncology and European Organisation for Research and Treatment of Cancer consensus on re-irradiation: definition, reporting, and clinical decision making.

Nicolaus Andratschke, Jonas Willmann, Ane L Appelt...

https://pubmed.ncbi.nlm.nih.gov/36174633

Meta-analysis of concomitant versus sequential radiochemotherapy in locally advanced non-small-cell lung cancer.

Anne Aupérin, Cecile Le Péchoux, Estelle Rolland...

https://pubmed.ncbi.nlm.nih.gov/20351327

Clinical Outcomes of Patients With Recurrent Lung Cancer Reirradiated With Proton Therapy on the Proton Collaborative Group and University of Florida Proton Therapy Institute Prospective Registry Studies.

Shahed N Badiyan, Michael S Rutenberg, Bradford S Hoppe...

https://pubmed.ncbi.nlm.nih.gov/30802618