Clinical trial NCT02376322: Hypofractionated Radiotherapy (16/2) for the Palliation of Complicated Bone Metastases in Patients With KPS
Official title: A Phase II Trial of Hypofractionated Radiotherapy (16 Gy in 2 Fractions With an Interval of One Week) for the Palliation of Complicated Bone Metastases in Patients With Poor Performance Status
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bone Metastases
Lead sponsor: Santa Casa de Porto Alegre
Sponsor class: OTHER
First posted: 2015-03-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Radiotherapy
Primary purpose: TREATMENT

Brief summary: Literature has shown that hypofractionated radiotherapy regimens are efficacious in patients with complicated bone metastases and have a low potential for severe treatment-related toxicities. There is a clear need for hypofractionated schedules in the complicated bone metastases population, especially when considering the overarching aim of palliative radiotherapy and the clinical features of this patient population. As well, current research examining hypofractionated approaches in bone metastases patients with impending or pathologic fractures, neuropathic pain or accompanying soft tissue masses has been markedly scarce.

Detailed description: In response the the already commented on, the purpose of this one armed, phase II trial is to determine the efficacy and safety profile of a hypofractionated radiotherapy regimen, 16 Gy in 2 fractions with an interval of one week, for the palliation of complicated bone metastases in patients with poor performance status.

Eligibility criteria: Inclusion Criteria:

1. Histologically or cytologically proven malignancy.
2. Patients aged 18 and above.
3. Advanced cancer patients with at least one complicated bone metastasis. A complicated bone metastasis will be operationally defined as a bone metastasis that has an accompanying: soft tissue mass or extraosseous component penetrating the normal cortical boundary; neuropathic pain; post surgical intervention for bone fixation; impending fracture or high fracture risk in weight bearing long bone as defined by Harrington's criteria but not surgical candidate: lytic bone lesion involving more than ½ the diameter of the bone cortex , greater than 2.5 cm in greatest diameter, or in the intertrochanteric line (29).
4. Patients with Karnofsky Performance Status (KPS) 30-60 at the time of baseline evaluation.
5. Patients who are planned to receive radiation treatment to the complicated site(s) being followed for study.
6. Patients who had surgery for complicated bone metastases.
7. Patients who are currently taking any systemic therapy (i.e. chemotherapy, hormone therapy, or bone modifying agents) or planning to begin systemic therapy within two weeks of treatment will be allowed to participate in the study; study personnel will note any use of systemic therapy in the study records.
8. Patients who are able to provide a worst pain score at the complicated site(s) being followed for study.
9. Patients who are able and willing to fill out a daily diary.
10. Patients who are able to provide informed consent prior to being enrolled to the study.

Exclusion Criteria:

1. Patients with leukemia or Hodgkin's/non-Hodgkin's lymphoma.
2. Patients who are surgical candidates with pathologic fractures or lesions at high risk for pathologic fracture in the humerus, radius, ulna, femur, tibia, or fibula. They will be eligible for post-operative hypofractionated radiotherapy.
3. Patients with spinal cord compression or cauda equina syndrome.
4. Patients who are currently receiving any radiopharmaceuticals.
5. Patients who are unable to record a pain score, complete a daily diary or to communicate requested information to study personnel.

Primary outcomes:
measure: Overall pain response at the site of treatment, which will be measured at two months post-treatment. Pain response will be measured using the International Consensus on Palliative Radiotherapy Endpoints Pain Response Categories.
timeFrame: 2 months after the end of the second radiotherapy fraction
Secondary outcomes:
measure: Quality of life as assessed by the EORTC QLQ PAL-15 and EORTC QLQ-BM22
timeFrame: General follow up will be 1 year after each patient inclusion
measure: Side effects of Radiotherapy.
timeFrame: General follow up will be 1 year after each patient inclusion
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: ISCMPA
state: RS
city: São Paulo
country: Brazil
facility: ICESP
state: SP
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Terni
country: Italy
facility: S. Maria Hospital
Study officials:
affiliation: Medical Doctor at Radiation Oncology Unit
name: Maurício F Silva, PhD
role: PRINCIPAL_INVESTIGATOR
References: