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comparison of two radiotherapy regimens in spinal cord compression patients

A phase III randomized controlled trial of two radiotherapy fractionation regimens in metastatic epidural spinal cord compression in lung cancer patients

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/04/024707
Enrollment
150
Registered
2020-04-17
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: C348- Malignant neoplasm of overlappingsites of bronchus and lung

Interventions

Intervention1: Intervention Arm: 8 Gy into Two fractions five -7 days apart Control Intervention1: Standard Arm: 20 Gy in 5 fractions of Radiotherapy once daily

Sponsors

Dr Anil Tibdewal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age > 18 years and 2.Pathologically proven lung malignancy 3.Patients with clinico â?? radiological diagnosis of MESCC 4.Willing and able to comply with all study requirements, including treatment; able to come for follow-up at regular intervals. 5.Patients able to come for at least first follow up 6.Patients who can provide signed written informed consent

Exclusion criteria

Exclusion criteria: 1.Surgical intervention for treatment of MESCC 2.Previous irradiation over the involved spine segments 3.Patients with symptomatic brain metastases 4.Patients not willing and not able to come for follow up 5.Pregnancy

Design outcomes

Primary

MeasureTime frame
To compare the response rate of pain and ambulation (defined as improvement or no deterioration) between the two dose fractionation regimens namely 8 Gy in two fractions (ARM 1) with 20 Gy in 5 fractions (ARM 2) at 4 weeks (-1 week to +2 weeks) in metastatic epidural spinal cord compression of lung cancer patients.Timepoint: 4 weeks

Secondary

MeasureTime frame
To compare response rates at 3 and 6 months To compare duration of response between two arms Incidence of Re-irradiation between two armsTimepoint: 3 and 6 months

Countries

India

Contacts

Public ContactAnil Tibdewal

Tata Memorial Hospital

aniltibdewal@gmail.com022-24177000

Outcome results

None listed

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