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

Primary Purpose

Bone Metastases

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Radiotherapy

About this trial

This is an interventional treatment trial for Bone Metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologically or cytologically proven malignancy.
Patients aged 18 and above.
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).
Patients with Karnofsky Performance Status (KPS) 30-60 at the time of baseline evaluation.
Patients who are planned to receive radiation treatment to the complicated site(s) being followed for study.
Patients who had surgery for complicated bone metastases.
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.
Patients who are able to provide a worst pain score at the complicated site(s) being followed for study.
Patients who are able and willing to fill out a daily diary.
Patients who are able to provide informed consent prior to being enrolled to the study.

Exclusion Criteria:

Patients with leukemia or Hodgkin's/non-Hodgkin's lymphoma.
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.
Patients with spinal cord compression or cauda equina syndrome.
Patients who are currently receiving any radiopharmaceuticals.
Patients who are unable to record a pain score, complete a daily diary or to communicate requested information to study personnel.

Sites / Locations

ISCMPA
ICESP
Sunnybrook Health Sciences Centre
S. Maria Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiotherapy in bone metastases

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Side effects of Radiotherapy.

Nausea and vomiting, pain flare, skin rash, esophagitis, mucositis, diarrhea, spinal cord/cauda equina compression, pathologic fracture, re-irradiation rate).

Full Information

NCT ID

NCT02376322

First Posted

February 10, 2015

Last Updated

October 4, 2017

Sponsor

Santa Casa de Porto Alegre

1. Study Identification

Unique Protocol Identification Number

NCT02376322

Brief Title

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

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

July 2014 (undefined)

Primary Completion Date

July 30, 2016 (Actual)

Study Completion Date

July 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Santa Casa de Porto Alegre

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bone Metastases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Radiotherapy

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Radiotherapy in bone metastases

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Radiotherapy

Intervention Description

Hypofractionated radiotherapy regimen, 16 Gy in 2 fractions in complicated bone metastases in patients with poor performance status

Primary Outcome Measure Information:

Title

Description

The general follow up will finish 1 year after each patient inclusion

Time Frame

2 months after the end of the second radiotherapy fraction

Secondary Outcome Measure Information:

Title

Quality of life as assessed by the EORTC QLQ PAL-15 and EORTC QLQ-BM22

Description

Quality of life assessed by these 2 questionnaries will follow composite information

Time Frame

General follow up will be 1 year after each patient inclusion

Title

Side effects of Radiotherapy.

Description

Nausea and vomiting, pain flare, skin rash, esophagitis, mucositis, diarrhea, spinal cord/cauda equina compression, pathologic fracture, re-irradiation rate).

Time Frame

General follow up will be 1 year after each patient inclusion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically or cytologically proven malignancy. Patients aged 18 and above. 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). Patients with Karnofsky Performance Status (KPS) 30-60 at the time of baseline evaluation. Patients who are planned to receive radiation treatment to the complicated site(s) being followed for study. Patients who had surgery for complicated bone metastases. 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. Patients who are able to provide a worst pain score at the complicated site(s) being followed for study. Patients who are able and willing to fill out a daily diary. Patients who are able to provide informed consent prior to being enrolled to the study. Exclusion Criteria: Patients with leukemia or Hodgkin's/non-Hodgkin's lymphoma. 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. Patients with spinal cord compression or cauda equina syndrome. Patients who are currently receiving any radiopharmaceuticals. Patients who are unable to record a pain score, complete a daily diary or to communicate requested information to study personnel.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maurício F Silva, PhD

Organizational Affiliation

Medical Doctor at Radiation Oncology Unit

Official's Role

Principal Investigator

Facility Information:

Facility Name

ISCMPA

City

Porto Alegre

State/Province

ZIP/Postal Code

90000

Country

Brazil

Facility Name

ICESP

City

São Paulo

State/Province

Country

Brazil

Facility Name

Sunnybrook Health Sciences Centre

City

Toronto

State/Province

Ontario

Country

Canada

Facility Name

S. Maria Hospital

City

Terni

Country

Italy

12. IPD Sharing Statement

Learn more about this trial

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

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