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Radiotherapy in globlastoma (brain tumor) patients

Phase I study of radiotherapy dose escalation using 68 Ga-Pentixafor PET/CT Scan in Glioblastoma patients

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/05/019146
Enrollment
20
Registered
2019-05-15
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: C719- Malignant neoplasm of brain, unspecified

Interventions

Intervention1: High dose radiotherapy: External beam Radiation will be delivered with Intensity Modulated Radiation Therapy (IMRT) technique under Image guidance (IGRT) Intervention2: High dose Radiot
Phase-I: 46GY in 23 fractions over 4.5 weeks, followed by Phase-II: 21GY in 7 fractions over 1.5 weeks. Total dose: 67GY. Control Intervention1: Nil: Nil

Sponsors

None
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Biopsy Proven case of GBM Age >= 18 years, Karnofsky Performance Status >= 60 Adequate bone marrow reserve

Exclusion criteria

Exclusion criteria: Age H/o prior malignancy Unwilling for written informed consent and follow-up Major medical illness or psychiatric impairment that will prevent completion of the protocol or would interfere with follow-up

Design outcomes

Primary

MeasureTime frame
1.To evaluate the feasibility of radiotherapy dose escalation based on 68Ga-Pentixafor-PET/CT scan in Globlastoma patients 2.To see the impact of dose escalation on response rate and survival Timepoint: One year from the date of last patient enrollment

Secondary

MeasureTime frame
To see the incidence of radio-necrosis To assess the quality of life To assess neuro-cognitive dysfunction Timepoint: After completion of treatment every three monthly evaluation to assess radio-necrosis status and quality of life up to one year

Countries

India

Contacts

Public ContactDr Chinna Babu Dracham

POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH (PGIMER)

chinnababudraksham@gmail.com9855803437

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 8, 2026