Hypofractionated Radiotherapy (16/2) for the Palliation of Complicated Bone Metastases in Patients With KPS

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

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.

Study Overview

• Status: Completed
• Conditions: Bone Metastases
• Intervention / Treatment: Radiation: Radiotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Porto Alegre, RS, Brazil, 90000
      • ISCMPA
  • SP
    • São Paulo, SP, Brazil
      • ICESP
• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • Sunnybrook Health Sciences Centre
• Italy
  • Terni, Italy
    • S. Maria Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radiotherapy in bone metastases; 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.	Radiation: Radiotherapy; Hypofractionated radiotherapy regimen, 16 Gy in 2 fractions in complicated bone metastases in patients with poor performance status

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The general follow up will finish 1 year after each patient inclusion	2 months after the end of the second radiotherapy fraction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life as assessed by the EORTC QLQ PAL-15 and EORTC QLQ-BM22	Quality of life assessed by these 2 questionnaries will follow composite information	General follow up will be 1 year after each patient inclusion
Side effects of Radiotherapy.	Nausea and vomiting, pain flare, skin rash, esophagitis, mucositis, diarrhea, spinal cord/cauda equina compression, pathologic fracture, re-irradiation rate).	General follow up will be 1 year after each patient inclusion

Collaborators and Investigators

• Sponsor: Santa Casa de Porto Alegre
• Investigators: Principal Investigator: Maurício F Silva, PhD, Medical Doctor at Radiation Oncology Unit

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): July 30, 2016
• Study Completion (Actual): July 30, 2016

Study Registration Dates

• First Submitted: February 10, 2015
• First Submitted That Met QC Criteria: February 24, 2015
• First Posted (Estimate): March 3, 2015

Study Record Updates

• Last Update Posted (Actual): October 6, 2017
• Last Update Submitted That Met QC Criteria: October 4, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplasms by Site; Hematologic Diseases; Musculoskeletal Diseases; Neoplastic Processes; Bone Diseases; Neoplasm Metastasis; Bone Neoplasms; Bone Marrow Diseases
• Other Study ID Numbers: ISCMPA01