to asses pain relief and side effects in patients with bone pain due to metastasis from advanced cancer with two types of radiation treatment regimes

RANDOMISED TRIAL TO ASSES PAIN RELIEF AND SIDE EFFECTS IN PATIENTS WITH NEUROPATHIC PAIN DUE TO BONE METASTASIS FOLLOWING EXTERNAL BEAM RADIOTHERAPY WITH 20GY IN 5 FRACTIONS VS 30 GY IN 10 FRACTIONS.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/06/001802

Enrollment

1071

Registered

2011-06-13

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: null- PTS WITH BONE METASTASIS secondary to primary malignancy

Interventions

Intervention1: EXTERNAL BEAM RADIOTHERAPY: PTS TREATED WITH EITHER 20 GY IN 5 FRACTIONS OVER 5 DAYS OR 30 GY IN 10 FRACTIONS OVER 10 DAYS

Eligibility

Inclusion criteria

Inclusion criteria: PATHOLOGICALLY CONFORMED MALIGNANCY PLAIN XRAY OR BONE SCAN WITH EVIDENCE OF BONE METASTASIS AT INDEX SITE, PAIN OR DYSASTHESIA PREDOMINANTELY NEUOPATHIC IN NATURE, LIFE EXPECTANCY ATLEAST 6 WEEKS, ABLE TO COMPLETE PAIN ASSESMENTS, WRITTEN INFORMED CONSENT

Exclusion criteria

Exclusion criteria: PRIOR RT TO INDEX SITE, RECEIVING NEW CONCURRENT SYSTEMIC TREATMENT,IMPENDING OR ESTABLISHED PATHOLOGICAL FRACTURE, PRIOR SURGICAL FIXATION,NEUROPATHIC PAIN DUE PRIMARILY TO EXTRASKELETAL TUMOR.

Design outcomes

Primary

Measure	Time frame
TO DETERMINE 20GY IN 5F IS AS EFFECTIVE AS 30GY IN 10F IN RELEIVING NEUROPATHIC BONE PAINTimepoint: 2MONTHS	—

Secondary

Measure	Time frame
ACUTE SIDE EFFECTS AND COMPLICATIONSTimepoint: WITHIN 2 MONTHS OF TREATMENT	—

Countries

India

Contacts

Public ContactDRPRABHAKAR

KERALA UNIVERSITY OF HEALTH SCIENCES

rmdeva2006@gmail.com09447031365

Outcome results

None listed

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