Table 2.
Current studies open in stereotactic body radiotherapy for oligoprogressive disease (OPD)
| Study | Estimated recruitment | Tumour type | No. OPD sites | Systemic treatment | Oligoprogression eligibility criteria | End points |
|---|---|---|---|---|---|---|
| Stereotactic radiotherapy for metastatic kidney cancer being treated with sunitinib Phase II multicentre single-arm trial |
n = 68 | RCC | ≤5 OPD metastases Maximum 3 lesions in soft tissue (EC or CNS metastases) |
First-line sunitinib | PD of individual lesion by RECIST v1.1, ≥5 mm increase in size New metastatic lesion Progressive enlargement of a known metastasis on 2 consecutive imaging studies 2–3 months apart, with ≥5 mm increase |
Primary end point: LC rate at 1 year Secondary end points: PFS, late and acute toxicity |
| STOP-NSCLC (Stereotactic radiotherapy for oligoprogressive NSCLC) Phase II randomised trial |
n = 54 | NSCLC | ≤5 OPD metastases, maximum 3 in any single organ (EC or CNS metastases) |
Any cytotoxic or targeted treatment for NSCLC | PD of individual lesion by RECIST v1.1 New metastatic lesion ≥5 mm Progressive enlargement of a known metastasis on 2 consecutive imaging studies 2–3 months apart, with ≥5 mm increase |
Primary end point: PFS Secondary end points: OS, QoL, toxicity, LC rate, total time on chemotherapy, duration of systemic treatment after SBRT, location of sites of further progression |
| HALT (Stereotactic body radiotherapy for the treatment of OPD) Multicentre, phase II/III randomised trial |
n = 110 | NSCLC with an actionable mutation receiving TKI treatment | ≤3 EC-OPD | TKI | Visible OPD on imaging suitable for SBRT as determined by HALT virtual MDT | Primary end point: PFS Key secondary and exploratory end points: OS, time to change in systemic treatment, patterns of progression, acute and late toxicity, QoL, ctDNA deep sequence analysis, PET/CT findings in relation to outcome, time to failure of next treatment |
| TRAP (Targeted radiotherapy in androgen-suppressed prostate cancer patients) Multicentre, phase II single-arm trial |
n = 84 | CRPC | ≤2 EC-OPD in lymph nodes, bone, prostate or lung only | Abiraterone/enzalutamide | Visible OPD suitable for SBRT or clinical progression | Primary end point: PFS Key secondary and exploratory end points: LC, proportion of patients with detectable ctDNA and ctDNA response to SBRT, development of a biomarker panel predicting for PFS, OS, acute and late toxicity, QoL, time to delay of next treatment, subgroup analysis of PFS of local prostate OPD to metastatic OPD, ctDNA kinetics to predict time to progression |
CNS, central nervous system; CRPC, castrate-resistant prostate cancer; ctDNA, circulating DNA; EC, extra-cranial; LC, local control; MDT, multidisciplinary team; NSCLC, non-small cell lung cancer; OS, overall survival; PD, progressive disease; PET/CT, positron emission tomography/computed tomography; PFS, progression-free survival; QoL, quality of life; RCC, renal cell carcinoma; RECIST, Response Evaluation Criteria in Solid Tumours; SBRT, stereotactic body radiotherapy; TKI, tyrosine kinase inhibitor.