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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/04/033060

Enrollment

Registered

2021-04-23

Start date

Unknown

Completion date

Unknown

Last updated

2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Low dose therapy: Single 0.5mCi/kg dose of Lu-177 EDTMP, injected Intravenously, Once. Control Intervention1: High dose therapy: Single 1mCi/kg dose of Lu-177 EDTMP, injected Intravenou

Eligibility

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1.Patients with the following cell count limits will not be considered for the therapy: Haemoglobin Total white cell count Platelet count 2.Patients with poor renal function i.e. estimated glomerular filtration rate 3.Patients with life expectancy less than 3 months. 4.Pregnant or lactating females if any.

Design outcomes

Primary

Measure	Time frame
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

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

Measure

Time frame

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

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Countries

India

Contacts

Public ContactRakesh Pandey

rajesh.nmd@gmail.com02912831467

Outcome results

None listed

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