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A study to find out the effectiveness of oral temozolomide along with radiation in patients with grade IV glial tumors using a short course of Intensity modulated Radiotherapy

A study to assess the safety and efficacy of Hypo-fractionated Intensity modulated Radiation Therapy with Simultaneous Integrated Boost Technique along with Concurrent and Adjuvant chemotherapy with Temozolomide in newly diagnosed, biopsy proven patients with Glioblastoma. - HISCAT

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/01/030334
Enrollment
51
Registered
2021-01-08
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G939- Disorder of brain, unspecified

Interventions

Intervention1: Hypo-fractionated Intensity modulated Radiation Therapy with Simultaneous Integrated Boost Technique along with Concurrent and Adjuvant chemotherapy with Temozolomide in newly diagnosed

Sponsors

Christian Medical College Vellore
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a. Histologically proven Glioblastoma b. Age 18-70 c. Karanofsky Performance score >70 d. Surgery done within 4 weeks prior to enrollment. e. Haematological parameters 1. Haemoglobin >10 gm /dL 2. Absolute Neutrophil Count >1500 cell /cu mm 3. Platelet count > 1 ,00,000 f. Liver Enzymes (SGOT , SGPT) g. Serum Bilirubin h. Serum Creatnine

Exclusion criteria

Exclusion criteria: a. Multifocal disease b. Unresectable patients c. Previous history of Radiation Therapy d. Not willing for followup

Design outcomes

Primary

MeasureTime frame
1. To assess the safety of Hypofractionated IMRT with SIB and concurrent Temozolomide 2. To assess 6 month progression free survival in patients with Glioblastoma Timepoint: 1.At baseline,1st week,2nd week, 3rd week, Fourth week 2.Baseline, completion of radiation therapy, Completion of adjuvant chemotherapy

Secondary

MeasureTime frame
1.To determine the 1-year overall survival 2.To evaluate the Quality of life at Pre-RT, end of RT and 6 months follow-up Timepoint: 1.One year 2. 0, 4 weeks, 7 Months

Countries

India

Contacts

Public ContactDr Jebin Samraj

Christian Medical College Vellore

jebin.samraj@cmcvellore.ac.in8754600770

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026