Comparing the Effectiveness of Combined Hyperthermia and External Beam Radiation (EBRT) Versus EBRT Alone in Treating Patients With Painful Bone Metastases

NCT01842048 | Unknown Phase 3 DMC

• 1 other identifier: 20120305D
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

The main goals of deep hyperthermia combined with external beam radiation (EBRT) on bone metastases are the response on pain relief, duration of response and time to achieve complete pain relief.

Conditions

All Type of Cancers With Bony Metastasis

Keywords

External-beam radiotherapy; Hyperthermia

Outcome Measures

Primary Outcomes (1)

• Complete response rate

  Complete response rate defined with Brief Pain Inventory score of zero plus no concomitant increase analgesic intake within 3 months after radiotherapy.

  24 weeks

Secondary Outcomes (4)

• Adverse events

  24 weeks

• Tumor response

  12 weeks

• Pain relief

  24 weeks

• Quality-of-life

  24 weeks

Study Arms (2)

External-beam radiotherapy combine hyperthermia

EXPERIMENTAL

Hyperthermia 42℃ ± 0.5℃ for 40min, 2 times/week within 2hr after irradiation. Radiation protocol are 3Gy 5 times a week for a total of 30Gy/10fx/2 weeks

Other: Hyperthermia; Radiation: External-beam radiotherapy

External-beam radiotherapy alone

ACTIVE COMPARATOR

External-beam radiotherapy alone comprising 30Gy/10 fractions, 5 times a week, administered with 2 weeks.

Radiation: External-beam radiotherapy

Interventions

Hyperthermia OTHER

External-beam radiotherapy combine hyperthermia

External-beam radiotherapy RADIATION

External-beam radiotherapy alone; External-beam radiotherapy combine hyperthermia

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or clinically confirmed solid tumor metastasis with index lesion involving or abutting bone. \*Index lesion means an irradiated field covered lesions contoured from CT-Simulation which may generally less than 20cm, include 4-5 vertebra bodies, sacrum plus adjacent iliac lesions or a segment of femerol bone. Each patient can only have one index lesion for this study.
• Index lesion with bone destruction either osteolytic or osteoblastic in nature as assessed on CT or MRI imaging
• If the nature of the metastatic disease has been previously documented, the index lesion to be treated does not require further documentation (i.e., biopsy)
• ≥ One primary painful metastatic site. The most painful site that need treatment first will be elected as index lesion site for evaluation of response. Additional less painful metastatic sites may be present. Patients who elect to have another course of RT treatment on different metastatic sites after the initial treatment are allowed.
• Worst pain in the last 24 hours must be ≥ 4 on a 0-10 numeric scale.
• Index lesion causing clinical or radiographic evidence of partial spinal cord or cauda equina compression/effacement is allowed.
• Have developed pain or have persistent pain while on a stable chemotherapy, hormonal therapy, target therapy or bisphosphonate therapy regimen is allowed. There will be no change of chemotherapy, hormonal therapy, or bisphosphonate therapy for 4 weeks before and after radiotherapy
• ECOG performance status 0-3
• Life expectancy ≥ 3 months
• Patients with impending fracture of weight bearing bone or patients with symptoms of spinal cord compression should have surgical opinion before the start of radiotherapy. Patient should not be able to be enrolled in this study if surgery is scheduled.

You may not qualify if:

• Index lesion involves the skull
• Index lesion has evidence of a pathologic fracture, impending fracture need immediate surgery are not eligible. Those patients had received decompression surgery are not eligible.
• Has undergone prior radiotherapy at the index lesion
• Those who chemotherapy or systemic treatment will be changed during study period.
• Patients had history of metal implant inside or outside irradiation field are not eligible .
• Patients had history of pacemaker insertion due to arrhythmia are not eligible.

Sponsors & Collaborators

• Shin Kong Wu Ho-Su Memorial Hospital: lead

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, 11101, Taiwan

RECRUITING

MeSH Terms

Conditions

Hyperthermia

Interventions

Diathermy

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Hyperthermia, Induced; Therapeutics

Central Study Contacts

Kwan-Hwa Chi, M.D.

CONTACT

886-2-28332211; M006565@ms.skh.org.tw

Yu-Shan Wang, Ph.D

CONTACT

886-2-28332211; T006659@ms.skh.org.tw

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2013
• First Posted: April 29, 2013
• Study Start: July 1, 2013
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: October 13, 2016

Record last verified: 2016-10

Locations

TW (1)