Stereotactic ablative radiotherapy (SABR) after systemic antineoplastic treatment for patients with unresectable oligometastases (lung; liver; adrenal glands) from solid tumours: SARASTRO Trial (Stereotactic Ablative Radiotherapy After Systemic TReatment for Oligometastases) A randomised phase II trial

Phase 2

Withdrawn

• Conditions: metastases; spread out cancer; 10027476

• Registration Number: NL-OMON37714
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

- Patients above age 18.
- WHO-PS (performance status) 0 - 1.
- Patients with unresectable metastases to lung, and/or liver, and/or one adrenal gland, who have received systemic therapy and show partial remission or stable disease.
- Using RECIST 1.1 criteria (see the Appendix): Partial response or stable disease at restaging (compared with staging prior to last 4*6 cycles of chemotherapy). Note this exception: After bevacizumab-containing treatment, response of liver metastases should be assessed using CT-morphologic criteria as described by Chun et al., JAMA 2009;302:2338
- Possibility to define target lesions that fulfil the following criteria:
- No lesion larger than 4 cm;
- Not more than 5 metastases >= 8 mm in total (lesions smaller than 8 mm in diameter are NOT counted and will NOT be irradiated);
- Not more than 3 lesions >= 8 mm in the lung;
- Not more than 3 lesions >= 8 mm in the liver;
- If adrenal gland metastasis: only unilateral lesion;
- primary tumour has been completely removed

Exclusion Criteria

Not fulfilling the inclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary: Rate of progression free survival at one year. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary: Local progression free survival; location of progression: irradiated<br /><br>target lesion / non-irradiated target lesion / both; rate of progression<br /><br>outside target lesions; time to failure of local strategy; relative change of<br /><br>tumour load at one year; rate of metastases in organs primarily unaffected;<br /><br>health-related quality of life and patient-rated specific symptoms; overall<br /><br>survival; same as primary and secondary endpoints assessed at two, three, and<br /><br>five years. </p><br>