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NTS-WBRT in Brain Metastases

ConditionBrain Metastases
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

About this trial

This research is being done to assess the quality of life and symptom burden in participants who receive (normal tissue sparing whole brain radiation therapy (NTS-WBRT).

This research study involves:

* NTS-WBRT (normal tissue sparing whole brain radiation therapy) * Memantine standard of care drug

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Any patient with a solid tumor diagnosis and any number of brain metastasis clinically indicated for cranial irradiation with whole brain radiation therapy

Age ≥ 18

Karnofsky Performance Status ≥ 70

Prior stereotactic radiosurgery (SRS) permissible per physician discretion

Disqualifiers

Leptomeningeal disease (by any one or more of clinical assessment, radiographic assessment, or cerebrospinal fluid study)

Prior whole brain radiation therapy

Pre-existing or current use of memantine or other NMDA antagonists

Known allergy to contrast used in imaging studies and/or inability to have MRI imaging

Trial design

Design model

Single group

Treatments tested in this trial

  • NTS-WBRT (normal tissue sparing whole brain radiation therapy)

    Radiation

    Radiation

  • Memantine

    Drug

    Capsule, taken orally

Treatment groups

41 Participants
are divided into 1 treatment group
Group A: NTS-WBRT (normal tissue sparing whole brain radiation therapy) + MemantineExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in Patient Reported Quality of Life for NTS-WBRT (normal tissue sparing whole brain radiation therapy)

Assessed by Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire. Score range is 0-200 and the higher the score, the better the outcome.

Time frame
4 Months
2

Change in Patient Reported Symptom Burden for NTS-WBRT (normal tissue sparing whole brain radiation therapy)

Assessed by Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire. Score range is 0-200 and the higher the score, the better the outcome.

Time frame
4 Months

Secondary outcomes

1

Tumor local control Rates between NTS-WBRT+SIB and NTS-WBRT

Estimated by the cumulative incidence function treating death as a competing risk, compared using Gray's test

Time frame
baseline, 2, 4, 6, 9, 12, 18 and 24 months
2

Intracranial- Progression Free Survival (PFS) between NTS-WBRT+SIB and NTS-WBRT

Estimated using the Kaplan-Meier method, compared using the logrank test

Time frame
baseline, 2, 4, 6, 9, 12, 18 and 24 months
3

Overall survival (OS) between NTS-WBRT+SIB and NTS-WBRT

Estimated using the Kaplan-Meier method, compared using the logrank test

Time frame
The date of randomization to the date of death, or otherwise censored at the last follow-up date for patients still alive up to 24 months
4

Change in Neurocognitive function between NTS-WBRT+SIB and NTS-WBRT

Assessed longitudinally by the HADS-D and HADS-A questionnaires

Time frame
baseline, 2, 4, 6, 9, 12, 18 and 24 months

Other outcomes

Sponsors and contacts

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

Massachusetts General Hospital

Lead sponsor

Source ClinicalTrials.gov
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