Trial Outcomes & Findings for Stem Cell Radiotherapy and Temozolomide for Newly Diagnosed High-grade Glioma (NCT NCT02039778)

Results Overview

The overall survival of patients with newly diagnosed high-grade glioma (HGG) treated with concurrent ScRT and temozolomide, followed by post-radiation temozolomide (and compare to historical controls).

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

12 months

Results posted on

2017-06-05

Participant Flow

Participant milestones

Participant milestones
Measure	Stem Cell Radiotherapy and Temozolomide Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy \[IMPT\] preferred) is an acceptable treatment modality. Stem Cell Radiotherapy (ScRT) and Temozolomide
Overall Study STARTED	4
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Stem Cell Radiotherapy and Temozolomide Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy \[IMPT\] preferred) is an acceptable treatment modality. Stem Cell Radiotherapy (ScRT) and Temozolomide
Overall Study Death	2
Overall Study Withdrawal by Subject	1
Overall Study Never started the protocol treatment	1

Baseline Characteristics

Stem Cell Radiotherapy and Temozolomide for Newly Diagnosed High-grade Glioma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stem Cell Radiotherapy and Temozolomide n=4 Participants Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy \[IMPT\] preferred) is an acceptable treatment modality. Stem Cell Radiotherapy (ScRT) and Temozolomide
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

The overall survival of patients with newly diagnosed high-grade glioma (HGG) treated with concurrent ScRT and temozolomide, followed by post-radiation temozolomide (and compare to historical controls).

Outcome measures

Outcome measures
Measure	Stem Cell Radiotherapy and Temozolomide n=4 Participants Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy \[IMPT\] preferred) is an acceptable treatment modality. Stem Cell Radiotherapy (ScRT) and Temozolomide
Overall Survival	1 Participants

PRIMARY outcome

Timeframe: 12 months

Population: no data available due to no subject completed the study. data not collected

The progression-free survival of patients with newly diagnosed HGG treated with concurrent ScRT and temozolomide, followed by post-radiation temozolomide (and compare to historical controls).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 months

The short-and long-term toxicity of ScRT (and compare to historical controls).

Outcome measures

Outcome measures
Measure	Stem Cell Radiotherapy and Temozolomide n=4 Participants Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy \[IMPT\] preferred) is an acceptable treatment modality. Stem Cell Radiotherapy (ScRT) and Temozolomide
Number of Participants With Adverse Events as a Measure of Safety and Tolerability	4 Participants

SECONDARY outcome

Timeframe: 36 month

Population: no data available due to no subject completed the study. data not collected

The potential neurocognitive effects of ScRT by the Hopkins Verbal Learning Test (HVLT), Mini-mental status exam (MMSE), Trail Making Tests A/B (TMT), and Controlled Word Association Test (COWAT).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 months

Population: no data available due to no subject completed the study. data not collected

The impact of ScRT on health-related quality of life (HRQOL) as assessed by EORTC Quality of Life Questionnaire (EORTC QLQ-C30)/Brain Cancer Module (BCM 20), Functional Assessment of Cancer Therapy with Brain Subscale (FACT-BR), and Activities of Daily Living Scale (ADLS) during ScRT.

Outcome measures

Outcome data not reported

Adverse Events

Stem Cell Radiotherapy and Temozolomide

Serious events: 2 serious events

Other events: 4 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Stem Cell Radiotherapy and Temozolomide n=4 participants at risk Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy \[IMPT\] preferred) is an acceptable treatment modality. Stem Cell Radiotherapy (ScRT) and Temozolomide
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Death	50.0% 2/4

Other adverse events

Other adverse events
Measure	Stem Cell Radiotherapy and Temozolomide n=4 participants at risk Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy \[IMPT\] preferred) is an acceptable treatment modality. Stem Cell Radiotherapy (ScRT) and Temozolomide
General disorders Fatigue	25.0% 1/4
General disorders Nausea	25.0% 1/4
General disorders Headache	25.0% 1/4
Skin and subcutaneous tissue disorders Dry skin	25.0% 1/4
Eye disorders Blurred vision	25.0% 1/4
Blood and lymphatic system disorders Platelet count decreased	25.0% 1/4

Additional Information

Dr. Rahul Parikh

Mount Sinai Beth Israel

Phone: 732-253-3939

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place