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

Bone Metastases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02376322
• Other study ID #: ISCMPA01
• Status: Completed
• Phase: Phase 2
• First received: February 10, 2015
• Last updated: October 4, 2017
• Start date: July 2014
• Est. completion date: July 30, 2016

Study information

• Verified date: October 2017
• Source: Santa Casa de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 30, 2016
• Est. primary completion date: July 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Bone Metastases
• Bone Neoplasms
• Neoplasm Metastasis

Intervention

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

Locations

Country	Name	City	State
Brazil	ISCMPA	Porto Alegre	RS
Brazil	ICESP	São Paulo	SP
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Italy	S. Maria Hospital	Terni

Sponsors (1)

Lead Sponsor	Collaborator
Santa Casa de Porto Alegre

Countries where clinical trial is conducted

Brazil,  Canada,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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