Disease outcomes and treatment toxicities of hypofractionated radiotherapy for newly diagnosed high grade gliomas- A prospective observational study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Progression Free Survival
Study Overview
Brief Summary
Hypofractionatedradiotherapy is well-accepted alternative to conventionally fractionatedlong-course radiotherapy in elderly patients, and has been considered to haveequivalent outcomes. In the wake of present pandemic situation that hasconstrained healthcare resources, there has been increasing adoption acrossmultiple centers of hypofractionated radiotherapy schedules, significantlyreducing the overall treatment time and thereby enhanced patient safety byensuring reduced hospital visits, in addition to reducing the departmentalworkload. Moreover the hypofractionated regimen has also been shown to havecomparable response rates. In our center hypofractionated radiotherapy has beenincreasingly adopted as an option for patients preferring a shorter courseregimen. This study aims to report the outcomes of hypofractionatedradiotherapy among patients who have preferred to undergo hypofractionatedradiotherapy.
Detaileddescription of procedure/process:
Patients with high grade gliomas, following surgeryand being planned for adjuvant radiotherapy, and meeting the eligibilitycriteria, will be explained about the options of conventional (60Gy/30-33#) andhypofractionated radiotherapy (40Gy/15#). They will be recruited if they arewilling to participate in the study and provide voluntary informed consent forthe same.
Radiotherapy planning will be done on MONACOPlanning system as per the standard practice. Single phase treatment volumewill be delineated on the planning CT as per standard guidelines(1).
If eligible, patients will also receive concurrentTemozolomide during RT, and 6 months of adjuvant Temozolomide thereafter, asper the standard practice.
Thepatient and treatment details will be recorded as per the proforma. They willbe followed up following treatment as per the standard practice, of once in 3-4months for the first two years, and less frequently thereafter.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 20.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Newly diagnosed high grade glioma post resection Performance Score 2/5.
Exclusion Criteria
- •Recurrent disease Poor Performance score.
Outcomes
Primary Outcomes
Progression Free Survival
Time Frame: 4 months,8 months and 12 months
Secondary Outcomes
- Overall Survival(Adverse effects of treatment)
