None listed
Conditions
Brief summary
This study aims to evaluate whether stereotactic ablative radiotherapy (SABR) is a reasonable and safe treatment option for patients with non-small cell lung cancer (NSCLC) where their cancer is large and/or has also spread to the nearby lymph nodes. Who is it for? You may be eligible to join this study if you are aged 18 or older with a diagnosis of stage III or IV non-small cell lung carcinoma and ineligible for standard of care concurrent chemo-radiotherapy. Study details Participants in this study will undergo stereotactic ablative radiotherapy (SABR). SABR is a specialised form of radiotherapy whereby large doses of radiation are given in fewer treatments. Participants will attend between 6-12 SABR sessions across 2-3 weeks, and will then be followed up regularly post radiotherapy, in order to evaluate treatment safety, quality of life, tumour response and survival. It is hoped this research will contribute to the field of oncology and improve the health outcomes of patients with lung cancer.
Interventions
Phase 1 - dose escalation trial of stereotactic ablative radiotherapy (SABR).
Each dose arm delivers a tumour dose biologically equivalent to the conventional regime of 60 Gy in 30 fractions over 6 weeks.
Arm 1 - 50.4 Gy in 12 fractions over 2.5 weeks
Arm 2 - 46 Gy in 8 fractions over 2-3 weeks
Arm 3 - 42 Gy in 6 fractions over 2-3 weeks
Treatment will be prescribed by the treating radiation oncologist after a discussion at a multidisciplinary meeting. Treatment will be administered in the r
Phase 1 - dose escalation trial of stereotactic ablative radiotherapy (SABR). Each dose arm delivers a tumour dose biologically equivalent to the conventional regime of 60 Gy in 30 fractions over 6 weeks. Arm 1 - 50.4 Gy in 12 fractions over 2.5 weeks Arm 2 - 46 Gy in 8 fractions over 2-3 weeks Arm 3 - 42 Gy in 6 fractions over 2-3 weeks Treatment will be prescribed by the treating radiation oncologist after a discussion at a multidisciplinary meeting. Treatment will be administered in the radiotherapy department at the hospital. During the SABR treatment you will be lying on a treatment couch whilst the radiation machine moves around you delivering the radiation. Prior to the treatment beginning the treatment staff will carry out imaging procedures to ensure the radiation is delivered accurately to your tumour. When the treatment machine is on you will not feel or see the radiation, you will only hear a buzzing noise. You will be in the treatment room for approximately 30 minutes for each treatment. Your treatment appointments will be scheduled Monday to Friday. In dose arms 2 and 3 you may have a day or two break between each treatment
Sponsors
Alfred Health
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed