To explore, whether the magnitude of the effect - in terms of progression free survival at one year - due to the addition of SABR after chemotherapy for selected patients with metastatic disease from solid (non-germinoma) tumours might justify a…
ID
Source
Brief title
Condition
- Metastases
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary: Rate of progression free survival at one year.
Secondary outcome
Secondary: Local progression free survival; location of progression: irradiated
target lesion / non-irradiated target lesion / both; rate of progression
outside target lesions; time to failure of local strategy; relative change of
tumour load at one year; rate of metastases in organs primarily unaffected;
health-related quality of life and patient-rated specific symptoms; overall
survival; same as primary and secondary endpoints assessed at two, three, and
five years.
Background summary
In case systemic antineoplastic therapy is indicated in the metastatic setting
of solid tumour treatment, it improves outcome in terms of deferring
progression of disease and prolonging survival by reducing tumour load.
Systemic antineoplastic treatment can eradicate microscopic tumour, made
evident by the increase of the rate of patients cured by adjuvant chemotherapy.
However, the induction of complete and permanent remission of macroscopic
metastatic tumour deposits is a rare event after systemic therapy. Surgical
metastasectomy is considered to be the only curative chance for patients with
resectable metastases. Stereotactic ablative radiotherapy (SABR) can induce
permanent local sterilisation of macroscopic tumour deposits, often expressed
as local control. It is challenging to hypothesize that the combination of
systemic drug therapy with locally ablative treatment could improve the outcome
for patients with metastatic disease.
Study objective
To explore, whether the magnitude of the effect - in terms of progression free
survival at one year - due to the addition of SABR after chemotherapy for
selected patients with metastatic disease from solid (non-germinoma) tumours
might justify a randomised phase III trial powered for difference.
Study design
Randomised phase II study in order to control for inevitable selection bias due
to inclusion criteria.
Intervention
Randomisation (1:1) between SABR to remaining metastases after chemotherapy
versus observation.
Study burden and risks
Chemotherapy is regarded standard treatment for most patients with unresectable
metastases from solid tumours. SABR is a safe (zero mortality) and little
burdensome treatment presently administered to patients with unresectable
metastases from various solid tumours outside clinical studies, if chemotherapy
is not indicated. Dose limits to critical structures are derived from phase
I/II research and single institution series and are implemented to avoid
relevant risk due to SABR. Frequently, SABR is presently chosen in order to
defer chemotherapy, if patients are to be spared toxicity from systemic
chemotherapy even in the absence of evidence from comparative trials. Patients
participating might benefit from SABR in case the progression rate is reduced
indeed by adding SABR to systemic therapy.
Postbus 30.001
9700 RB Groningen
NL
Postbus 30.001
9700 RB Groningen
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL39005.042.11 |