Comparison Of Low Vs High Dose 177Lu-EDTMP Therapy For Palliation Of Painful Bone Metastases: RCT.

Phase 3

• Conditions: Health Condition 1: C419- Malignant neoplasm of bone and articular cartilage, unspecified

• Registration Number: CTRI/2021/04/033060
• Lead Sponsor: AIIMS Jodhpur

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Patients with greater than 18 years of age, with HPE confirmed cancer.

2. Patients having painful metastatic bone lesions with osteoblastic response, as confirmed by areas of intense uptake on radionuclide bone scans at painful sites.

3.The patients on naive or prior analgesic therapy.

4.The minimum VAS/NRS score without medication should be > 4.

5.The patientâ??s KPS score should be > 30 and ECOG < 3.

6.Time interval between 177Lu-EDTMP therapy and prior chemotherapy or radiotherapy should be greater than four weeks.

Exclusion Criteria

1.Patients with the following cell count limits will not be considered for the therapy:

Haemoglobin < 9 g/dL

Total white cell count < 3000/μL

Platelet count < 60000/μL

2.Patients with poor renal function i.e. estimated glomerular filtration rate < 30 mL/ min.

3.Patients with life expectancy less than 3 months.

4.Pregnant or lactating females if any.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To find difference in pain relief in patients of bony metastases receiving high dose vs low dose 177Lu-EDTMP therapy.Timepoint: 2, 4, 8, 12 weeks following therapy

Secondary Outcome Measures

Name	Time	Method
1.To find and compare improvement in quality of life as assessed by KPS/ECOG scale between the two groups. <br/ ><br>2.To compare reduction in analgesic dose post therapy in both groups. <br/ ><br>3.To find and compare the duration of pain relief achieved between the two groups. <br/ ><br>4.To evaluate change in haematological and biochemical parameters post therapy between both the groups. <br/ ><br>5.To look for any other adverse effect. <br/ ><br>6.Bone scan quantification for response assessment and comparison between two groups. <br/ ><br>Timepoint: 2, 4, 8, 12 weeks following therapy