MedPath

A clinical study to evaluate confirmity to treatment, illness result, and quality-of-life in patients with advanced brain tumor (glioma) treated with uninterrupted short-course hypofractionated radiation therapy

Phase 2
Conditions
Health Condition 1: null- High grade Glioma
Registration Number
CTRI/2012/11/003141
Lead Sponsor
Tata Memorial Centre Tata Memorial Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
55
Inclusion Criteria

1.Poor-prognosis HGG defined as

a] Patient aged >18 but <=50 years with KPS <=40 and/or NPS>=3

b] Patients aged >50 but <=65 years with KPS <=60 and/or NPS >=2

c] Patients over >65 years of age with KPS <=80 and/or NPS >=1

2. Histo-pathologically proven HGG including variants 3. Available pre-surgical imaging (CT/MRI)

4. Written informed consent from patient/care- giver

5. Adjuvant therapy starting within 6 weeks (preferably within 4 weeks) of surgery

6. Life-expectancy of at least 3 months

Exclusion Criteria

1 Children 18 years of age

2 Patients deemed suitable for conventionally fractionated radiotherapy

3 Unconfirmed histology

4 Recurrent/progressive disease or

transformed HGG from previous low-grade glioma

5 Carmustine wafers implanted at surgery

6 Pregnancy or lactating women

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Compliance to continuous short-course hypofractionated radiation therapyTimepoint: Two weeks
Secondary Outcome Measures
NameTimeMethod
a] Median survival in months, 6-month overall survival, and 1-year overall survival <br/ ><br> b] Change in QOL scores serially longitudinally over time <br/ ><br>Timepoint: 6 months to 1 year
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