Stereotactic ablative radiotherapy for locally-advanced non-small cell lung cancer

Phase 1

Recruiting

• Conditions: Locally-advanced non-small cell lung cancer; ocally-advanced non-small cell lung cancer; Cancer - Lung - Non small cell

• Registration Number: ACTRN12619001186145
• Lead Sponsor: Alfred Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-22
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Diagnosis of stage III or IV non-small cell lung carcinoma. Based on clinical or histologic grounds.
- Ineligible for standard of care concurrent chemoradiotherapy as determined by a multidisciplinary group.
- Estimated life expectancy >6 months. Scoring using a Victorian Lung Cancer Prognostic Index is suggested for guidance.
- Recommended a course of radiotherapy to the lung and mediastinal disease.
- Over 18 years of age and available for follow up.

Exclusion Criteria

- Previous radiotherapy to the chest.
- History of another primary cancer within the last 2 years, with the exception of non-melanomatous skin cancer and carcinoma in situ of the cervix.
- Significant medical conditions which in the opinion of the investigator would compromise the planned delivery of the radiotherapy or which may be potentially exacerbated by the treatment.
- Pregnant or breast feeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose (MTD) of SABR assessed using a bayesian data augmentation dose finding with the continual reassessment method (DA-CRM). MTD is determined by the occurrence of a dose limiting toxicity (DLT) (as defined by CTCAE criteria) up to 12 months after the first dose of radiotherapy. <br><br>A DLT is defined as: <br>- Any grade 4-5 acute toxicity occurring during or <90 days post completion of RT, or, <br>- Any grade 3-5 late toxicity occurring > 90 days post completion of radiotherapy and up to 12 months after the first dose of radiotherapy.[Toxicity will be assessed weekly throughout treatment and at 6 weeks, 3, 6 and 12 months following treatment completion via face-to face appointments with the treatment doctor. Patients will be instructed to notify the treatment doctor if any side effects occur between scheduled appointments. Side effects may occur in the surrounding thoracic organs such as lung, oesophagus, heart or blood vessels.]