To determine the safety and feasibility of primer shot fractionation for NSCLC.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is whether patients finish the radiotherapy schedule as
planned (completion of all 5 fractions and two or less additional unplanned
days between fractions).
Secondary outcome
Secondary endpoints are tumor response at the end of treatment and 3 months
thereafter, and acute toxicity.
Background summary
Radiotherapy employs uniform, equally spaced weekday fractions that do not
account for changes in tumor radiosensitivity. However, radiobiological
characteristics evolve during the radiotherapy schedule as reoxygenation
increases radiosensitivity. In tumor-response simulations and preclinical
experiments, it was superior to prime the tumor with one radiotherapy fraction,
followed by a treatment break permitting mitotic cell death and reoxygenation
of tumor cells.
Study objective
To determine the safety and feasibility of primer shot fractionation for NSCLC.
Study design
A prospective non-randomized feasibility trial to test the safety of primer
shot fractionation in a 3+4 phase with increasing treatment breaks, followed by
an expansion cohort.
Intervention
All treatments are 5x6 Gy to all targets. Patients receive an increasing primer
shot treatment break. In the 3+4 phase, the break between the first and the
second radiotherapy fraction is: 1, 2 and 3 weeks. The maximum tolerated break
length will be used for the expansion cohort.
Study burden and risks
Based on simulations and preclinical data, primer shot treatment breaks
increase tumor control. However, the increased overall treatment time could
potentially increase the chance a patient drops out before the radiotherapy
schedule is finished. Because of the gradually prolonged break, this risk is
relatively small and acceptable for this population. Additionally, patients are
asked to fill in PRO-CTCAE lung subset questionnaires at the start of treatment
and during follow-up. They will also receive 1 additional CT with contrast at
fraction 5.
Plesmanlaan 121
Amsterdam 1066CX
NL
Plesmanlaan 121
Amsterdam 1066CX
NL
Listed location countries
Age
Inclusion criteria
• Age >= 18 years
• NSCLC (either pathology proven or sufficient clinical suspicion to be treated
as NSCLC), referred for palliative radiotherapy of at least the primary tumor
site (to eleviate or prevent symptoms like shortness of breath, coughing, pain
or hemoptysis).
• NSCLC, stage 2-4
• WHO performance score 0*2.
• Provision of signed, written and dated IC prior to any study specific
procedures.
Exclusion criteria
• Interstitial lung disease
• Treatment with vascular endothelial growth factor receptor (VEGFR) inhibitors
• Prior thoracic radiotherapy (>20 Gy EQD2 a/b 3) overlapping with the current
planning target volume
• Pregnant
Design
Recruitment
Medical products/devices used
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 | NL86077.041.24 |