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Radiation Therapy

Radiation Therapy for Bone Cancer (1-2 PUNCH Trial)

Phase 3

Recruiting

Led By Timothy Struve, MD

Research Sponsored by University of Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

There must be clearly attributable pain associated with the new metastatic bone lesion(s)

Patients must have histologically or cytologically confirmed history of solid cancer malignancy (including small cell lung cancer)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years post treatment.

Awards & highlights

1-2 PUNCH Trial Summary

This trial is testing if a higher dose of radiation given over a shorter period of time is more effective at reducing pain and improving quality of life for people with metastatic bone disease than the current standard of care.

Who is the study for?

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.Check my eligibility

What is being tested?

The study compares two radiation therapy doses for bone metastasis pain relief: a conventional single dose of 8 Gy versus an experimental split dose of 16 Gy in total. Participants will be randomly assigned to one of these treatments in equal numbers and monitored for pain reduction and quality of life improvements.See study design

What are the potential side effects?

Radiation therapy may cause side effects such as skin irritation at the treatment site, fatigue, mild swelling around the treated bones, nausea, and a temporary increase in pain before it decreases ('pain flare'). Long-term effects can include weakened bones.

1-2 PUNCH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I experience pain from new cancer spread to my bones.

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My cancer diagnosis was confirmed through tissue or cell testing.

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I am 18 years old or older.

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My cancer is in a major bone like my arm, leg, pelvis, spine, or ribs.

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I have 1 to 3 new or more painful bone lesions as shown in my scans.

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I can care for myself but may not be able to do any physical work.

1-2 PUNCH Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years post treatment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years post treatment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years post treatment. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pain

Pain Response measured by the Brief Pain Inventory

Safety through 30 days post-radiation

Secondary outcome measures

Overall survival through 2 years post-treatment.

Quality of Life (EORTC QLQ-C30) at Baseline, 1, 3, and 6 months post treatment

Quality of Life (EORTC QLQBM22) at Baseline, 1, 3, and 6 months post treatment

+2 more

1-2 PUNCH Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Experimental Radiation DoseExperimental Treatment1 Intervention

16 Gy in 2 fractions

Group II: Conventional Radiation DoseActive Control1 Intervention

8 Gy in a single fraction

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of CincinnatiLead Sponsor

428 Previous Clinical Trials

634,218 Total Patients Enrolled

Timothy Struve, MDPrincipal InvestigatorUniversity of Cincinnati

Media Library

Conventional Radiation Dose (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05115331 — Phase 3

Bone Cancer Research Study Groups: Conventional Radiation Dose, Experimental Radiation Dose

Bone Cancer Clinical Trial 2023: Conventional Radiation Dose Highlights & Side Effects. Trial Name: NCT05115331 — Phase 3

Conventional Radiation Dose (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05115331 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any more spots open in this research project?

"That is accurate, the trial is still open for recruitment. As seen on clinicaltrials.gov, the listing for this study was created on November 24th, 2021 and has not been updated since. 168 individuals are needed to complete the study at a single site."

Answered by AI

How many people total are included in the data sample for this research project?

"Yes, the trial is still ongoing and actively recruiting patients. The listing on clinicaltrials.gov shows that the trial was posted on November 24th, 2021 and has not been updated since. The trial is looking for 168 patients at a single site."

Answered by AI