External Beam Radiation Therapy Post Surgery in Patients With Lower Extremity Bone Metastases Randomized Efficacy Trial

NCT04109937 | Withdrawn DMC

• 1 other identifier: EXPLORE
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the present study is to evaluate the effectiveness of post-operative radiation therapy in lower extremity bone metastases. This trial will compare the health outcomes of patients receiving radiation therapy after Orthopaedic surgery to patients who will not receive radiation therapy post-surgery. The primary objective of the study is to compare the need for a subsequent surgery at the same treatment site within 12 months of the initial surgery. Additionally, the need for radiation or re-irradiation, functional status, performance status, pain scores, radiologically detected local disease progression, and overall length of survival will be compared at clinical endpoints for the two study arms. It is hypothesized that those randomized to receive post-operative radiation therapy will less likely need a subsequent surgery within the 12 months after the primary surgical intervention. This may optimize the quality of life for this patient population.

Conditions

Bone Metastases; Lower Extremity Fracture; Pathological Fracture; Impending Fracture

Outcome Measures

Primary Outcomes (1)

• Subsequent surgery after primary surgery

  Requirement of a subsequent surgery

  12 months following the date of primary surgery

Secondary Outcomes (8)

• Re-irradiation/radiation

  Weeks 2 & 6, Months 3, 6, 12, 18, and 24

• Subsequent surgery (between 13 months and 24 months)

  Between 13 months and 24 months following date of primary surgery

• Post-operative functional status and Karnofsky Performance Status (KPS)

  Weeks 2 & 6, Months 3, 6, 12, 18, and 24

• Post-operative pain and analgesic use

  Weeks 2 & 6, Months 3, 6, 12, 18, and 24

• Radiologically determined local progression

  Months 3, 6, 12, 18, and 24

Study Arms (2)

Surgery Alone

NO INTERVENTION

Patients with lower extremity bone metastases will receive surgical fixation/reconstruction but will not receive any post-operative radiation therapy.

Surgery and Post-Operative Radiation Therapy

ACTIVE COMPARATOR

Patients with lower extremity bone metastases will receive surgical fixation/reconstruction and will receive any post-operative radiation therapy.

Radiation: External beam radiation therapy

Interventions

External beam radiation therapy RADIATION

The post-operative radiation will cover entire prosthesis/surgical fixation device and will consist of the dose fractionation of: 20 Gy in 5 fractions or 30 Gy in 10 fractions.

Surgery and Post-Operative Radiation Therapy

Eligibility Criteria

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

You may qualify if:

• Is the patient 18 years of age or older at the time of randomization?
• Does the patient have histologically or cytologically proven malignancy?
• Does the patient have imaging confirming presence of bone metastases corresponding to clinically painful area?
• Does the patient have established bone metastatic pathological fracture(s) lower extremity OR has impending pathological fracture(s)?
• Does patient have KPS ≥40 with estimated survival of ≥ 6 months?
• Was informed consent obtained?

You may not qualify if:

• Did the patient have a prior impending or prior pathological fracture to the site and was previously fixed with orthopaedic surgery?
• Did the patient receive prior radiation to the site (external beam or stereotactic body radiation)?
• Did the patient have a radio-resistant tumor (renal cell carcinoma or melanoma)?
• Did the patient plan for radical resection of the bone metastases?
• Did the patient receive or is planning to receive other intra-operative tumor ablative therapies?

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Fractures, Spontaneous

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Study Officials

• Patrick Henry, MD FRCS(C)

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Study is not blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to receive 1 of the 2 treatment arms.

Study Record Dates

• First Submitted: September 27, 2019
• First Posted: October 1, 2019
• Study Start: October 1, 2020
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

CA (1)