Stereotactic body radiotherapy for the treatment of OPD

Not Applicable

• Conditions: Cancer; ung cancer; Lung cancer

• Registration Number: ISRCTN53398136
• Lead Sponsor: Institute of Cancer Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-08
• Last Update Posted: 1 April 2024
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Current inclusion criteria as of 25/10/2021:
1. Male or female, =16 years of age
2. Established histological diagnosis of advanced NSCLC, not suitable for radical treatment, with defined actionable mutation receiving targeted TKI therapy
3. Clinical and/or radiologically confirmed response to TKI therapy (assessed locally usually 2-3 months post commencing TKI)
4. Confirmed OPD defined as =5 extracranial sites of progressive disease. All sites must be visible, imaging defined targets and suitable for treatment with SBRT as determined by the virtual MDT and in accordance with the HALT Radiotherapy planning and delivery guidance document.
5. Adequate baseline organ function to allow SBRT to all relevant targets
6. Predicted life expectancy =6 months
7. Karnofsky Index =60% and ECOG 0-2
8. Provision of written informed consent

Previous inclusion criteria:
1. Male or female, =16 years of age
2. Established histological diagnosis of advanced NSCLC, not suitable for radical treatment, with defined actionable mutation receiving targeted TKI therapy
3. Clinical and/or radiologically confirmed response to TKI therapy (assessed locally usually 2-3 months post commencing TKI)
4. Confirmed OPD defined as =3 extracranial sites of progressive disease. All sites must be visible, imaging defined targets and suitable for treatment with SBRT as determined by the virtual MDT and in accordance with the HALT Radiotherapy planning and delivery guidance document.
5. Adequate baseline organ function to allow SBRT to all relevant targets
6. Predicted life expectancy =6 months
7. Karnofsky Index =60% and ECOG 0-2
8. Provision of written informed consent

Exclusion Criteria

Current exclusion criteria as of 25/10/2021:
1. >5 extracranial sites of progressive disease
2. Progressing or newly diagnosed brain metastases identified at the time of trial entry, not amenable to radical surgery or SRS. Previously treated brain metastases (i.e palliative radiotherapy or systemic therapy) which have remained clinically and radiologically stable for =6 months are permissible.
3. Prior radiotherapy near the oligoprogressive lesion precluding ablative SBRT
4. Co-morbidities considered clinically to preclude safe use of SBRT e.g. IPF in patients with an oligoprogressive lung lesion, inflammatory bowel disease in patients with an oligoprogressive pelvic lymph node
5. Any psychological, sociological or geographical issue potentially hampering compliance with the study
6. Pregnancy

Previous exclusion criteria:
1. >3 extracranial sites of progressive disease
2. Brain metastases not amenable to radical surgery or SRS
3. Prior radiotherapy near the oligoprogressive lesion precluding ablative SBRT
4. Co-morbidities considered clinically to preclude safe use of SBRT e.g. IPF in patients with an oligoprogressive lung lesion, inflammatory bowel disease in patients with an oligoprogressive pelvic lymph node
5. Any psychological, sociological or geographical issue potentially hampering compliance with the study
6. Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified