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Testing Longer Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With Cancer That Has Spread to the Brain

ConditionsAnatomic Stage IV Breast Cancer AJCC v8Metastatic Breast CarcinomaMetastatic Digestive System CarcinomaMetastatic Lung Non-Small Cell CarcinomaMetastatic Malignant Neoplasm in the BrainMetastatic Malignant Solid NeoplasmMetastatic MelanomaMetastatic Renal Cell CarcinomaStage IV Lung Cancer AJCC v8Stage IV Renal Cell Cancer AJCC v8
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNRG Oncology

About this trial

This phase III trial compares the effectiveness of fractionated stereotactic radiosurgery (FSRS) to usual care stereotactic radiosurgery (SRS) in treating patients with cancer that has spread from where it first started to the brain. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. FSRS delivers a high dose of radiation to the tumor over 3 treatments. SRS is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. FSRS may be more effective compared to SRS in treating patients with cancer that has spread to the brain.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Non-small cell lung cancer

Melanoma

Breast cancer

Renal cell carcinoma

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Computed Tomography

    Procedure/Surgery

    Undergo CT

  • Fractionated Stereotactic Radiation Therapy

    Radiation

    Undergo FSRS

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Stereotactic Radiosurgery

    Radiation

    Undergo SRS

Treatment groups

269 Participants
are divided into 2 treatment groups
Group A: ARM I (SRS)Active comparator 3 interventions
Group B: ARM II (FSRS)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Time to local failure

The time to local failure will be evaluated at a per-patient level. The cause-specific hazard ratio will be estimated in a Cox proportional hazards (PH) model adjusting for patients and disease characteristics. The Cox PH model will be the principle approach. The cumulative incidence function estimator will also be used to estimate the rate of local failure in the presence of competing event of deaths in the two arms separately. A complementary analysis will involve Gray's test to evaluate the difference in the distribution of local failure between treatment arms. These results will be interpreted in light of the competing deaths.

Time frame
From randomization (with the treatment planning magnetic resonance imaging as the 'baseline' for purposes of disease assessment) to local tumor progression of any study lesion(s), assessed up to 5 years

Secondary outcomes

1

Intracranial progression-free survival (IPFS)

IPFS will consist of estimation of its distribution for each treatment arm via the Kaplan-Meier method and a stratified log-rank test. Statistical power will depend on the total IPFS events accumulated at trial end.

Time frame
From the date of randomization until intracranial progression (local or distant intracranial) or death from any cause, whichever occurs first, assessed up to 5 years
2

Overall survival

Will consist of estimation of its distribution for each treatment arm via the Kaplan-Meier method and a stratified log-rank test. Reasons for death (e.g. due to neurological cause \[any central nervous system event such as an intracranial mass, hemorrhage, or hydrocephalus\] or non-neurological cause) will be recorded.

Time frame
From the date of randomization until death from any cause, assessed up to 5 years
3

Time to radiation necrosis (TTRN)

The rate of radiation necrosis will be compared in patients who receive fractionated stereotactic radiosurgery to patients who receive stereotactic radiosurgery. The primary comparison of treatment effect on TTRN will be based on testing the cause-specific hazard ratio (CHR) in a univariate Cox proportional hazards model. Additional supplementary analyses will include estimating the cause specific ratio in a Cox proportional hazards model adjusting for patients and disease characteristics (e.g. stratification randomization factors) and estimating the median TTRN via the cumulative incidence function estimator (Korn 1992). The Gray's test will also be used to evaluate the difference in the distribution of TTRN between treatment arms (Gray 1988).

Time frame
From randomization until radiation necrosis, assessed up to 5 years
4

Time to whole brain radiation therapy (WBRT)

Analysis of time to WBRT will consist of estimation of its distribution for each treatment arm via the Kaplan-Meier method and a stratified log-rank test. For patients who die prior to WBRT, time to WBRT will be censored at time of death.

Time frame
Up to 5 years

Other outcomes

1

Time to local failure

Estimates of the primary outcome treatment effect and the corresponding 95% confidence interval will be provided by sex, race, and ethnicity.

Time frame
Up to 5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NRG Oncology

Lead sponsor

Source ClinicalTrials.gov
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