comparison of two radiotherapy regimens in spinal cord compression patients
Phase 3
- Conditions
- Health Condition 1: C348- Malignant neoplasm of overlappingsites of bronchus and lung
- Registration Number
- CTRI/2020/04/024707
- Lead Sponsor
- Dr Anil Tibdewal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Age > 18 years and <= 75 years
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method To compare response rates at 3 and 6 months <br/ ><br>To compare duration of response between two arms <br/ ><br>Incidence of Re-irradiation between two armsTimepoint: 3 and 6 months