Radiation Therapy for Bone Cancer
(1-2 PUNCH Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a randomized Phase III study evaluating the efficacy of hypofractionated and dose-escalated palliative radiation therapy in metastatic bone disease (MBD). Patients will be randomized 1:1 to the conventional (8 Gy in a single fraction) and experimental (16 Gy in 2 fractions) groups with baseline and subsequent assessment of both pain and quality of life metrics.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot have chemotherapy within 2 weeks before starting the study, but you can continue hormonal or endocrine therapies during the trial.
Is radiation therapy for bone cancer generally safe for humans?
How is the radiation therapy treatment for bone cancer different from other treatments?
This treatment uses external beam radiation therapy (EBRT) to relieve pain and prevent complications from bone cancer, offering flexibility in dosage and schedule, such as single or multiple sessions, which can be tailored to the patient's needs. It is generally well-tolerated and can provide pain relief within days, making it a unique option compared to other therapies.46789
What data supports the effectiveness of this treatment for bone cancer?
Research shows that radiation therapy, including external beam radiation therapy (EBRT) and hypofractionated radiation therapy (shorter courses of treatment), is effective in managing pain from bone metastases. Studies indicate that shorter courses of radiation can be just as effective as longer ones for pain relief, making them a viable option for palliative care.810111213
Who Is on the Research Team?
Timothy Struve, MD
Principal Investigator
University of Cincinnati
Are You a Good Fit for This Trial?
Adults with solid cancer and 1-3 new or newly painful bone metastases, confirmed by scans. They should have pain linked to these lesions, be able to perform daily activities (ECOG ≤3 or Karnofsky ≥40%), and not have widespread metastatic disease that would affect the trial's results. Pregnant women, those with liquid malignancies like lymphoma, uncontrolled illnesses, or recent chemotherapy are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Radiation Treatment
Participants receive either conventional (8 Gy in a single fraction) or experimental (16 Gy in 2 fractions) palliative radiation therapy
Follow-up
Participants are monitored for pain response and safety, with assessments at 1 month post radiation completion
Extended Follow-up
Participants' pain response, quality of life, and overall survival are assessed at 2, 3, 6 months, and up to 2 years post-treatment
What Are the Treatments Tested in This Trial?
Interventions
- Conventional Radiation Dose
- Experimental Radiation Dose
Conventional Radiation Dose is already approved in European Union, United States, Canada, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Cincinnati
Lead Sponsor