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Photon Therapy

Proton vs Photon Therapy for Liver Cancer

Phase 3

Recruiting

Led By Theodore Hong

Research Sponsored by NRG Oncology

Eligibility Criteria Checklist

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

Must have

Must have Child-Turcotte-Pugh (CTP) A or B7

Pathologically (histologically or cytologically) or radiographically-proven unresectable or locally recurrent hepatocellular cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of randomization to the date of death due to any cause or date of last follow-up for alive patients. this analysis occurs after 125 deaths have been observered; estimated to occurs around 5 years.

Awards & highlights

Study Summary

This trial compares proton therapy to photon therapy in treating liver cancer. Proton therapy may cause less damage to healthy organs and result in better survival.

Who is the study for?

This trial is for adults with liver cancer who have up to three tumors, meeting specific size requirements. They must have adequate organ function, may have had previous treatments like chemotherapy or surgery, and need a performance status showing they can carry out daily activities. Pregnant women or those not using contraception are excluded.Check my eligibility

What is being tested?

The study compares two types of radiation therapy: photon therapy (high energy x-rays) and proton therapy (proton particles). Proton therapy might cause less damage to healthy organs around the tumor and potentially improve survival rates in liver cancer patients.See study design

What are the potential side effects?

Radiation therapies like photons and protons could lead to fatigue, skin reactions at the treatment site, nausea, potential damage to surrounding healthy tissue resulting in organ dysfunction, but specifics will vary between individuals.

Eligibility Criteria

Inclusion Criteria

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

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My liver function is classified as CTP A or B7.

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My liver cancer cannot be removed by surgery.

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I have up to 3 tumors that meet the size criteria.

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My cancer stage fits the study requirements based on recent scans.

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My cancer can be measured by tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of randomization to the date of death due to any cause or date of last follow-up for alive patients. this analysis occurs after 125 deaths have been observered; estimated to occurs around 5 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of randomization to the date of death due to any cause or date of last follow-up for alive patients. this analysis occurs after 125 deaths have been observered; estimated to occurs around 5 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of randomization to the date of death due to any cause or date of last follow-up for alive patients. this analysis occurs after 125 deaths have been observered; estimated to occurs around 5 years. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Overall Survival (OS)

Secondary outcome measures

Correlation of Hepatocyte Growth Factor (HGF) biomarker with OS, PFS and fatigue

Exploratory - Overall Quality of Life (QOL)

Fatigue as measured by the PROMIS fatigue short form version 1.0 8a

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Proton Therapy (Radiation Therapy)Experimental Treatment1 Intervention

Patients undergo proton therapy over 15-24 days for 5 or 15 fractions.

Group II: Photon Therapy (Radiation Therapy)Experimental Treatment1 Intervention

Patients undergo photon therapy over 15-24 days for 5 or 15 fractions.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

NRG OncologyLead Sponsor

231 Previous Clinical Trials

100,666 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,661 Previous Clinical Trials

40,924,207 Total Patients Enrolled

104 Trials studying Liver Cancer

26,668 Patients Enrolled for Liver Cancer

Theodore HongPrincipal InvestigatorNRG Oncology

1 Previous Clinical Trials

1 Total Patients Enrolled

Media Library

Photon Therapy (Photon Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03186898 — Phase 3

Liver Cancer Research Study Groups: Photon Therapy (Radiation Therapy), Proton Therapy (Radiation Therapy)

Liver Cancer Clinical Trial 2023: Photon Therapy Highlights & Side Effects. Trial Name: NCT03186898 — Phase 3

Photon Therapy (Photon Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03186898 — Phase 3

Frequently Asked Questions

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

At how many hospitals is this trial being done?

"Presently, this trial is running at 17 different sites. Some of these locations include Dearborn, Atlanta and West Chester. To minimize travel requirements, patients are encouraged to select the site closest to them."

Answered by AI

Are researchers still looking for study participants?

"The study, which is still recruiting patients according to clinicaltrials.gov, was originally posted on June 22nd, 2017 and updated for the last time on August 11th, 2022."

Answered by AI

Has Proton Therapy (Radiation Therapy) undergone FDA scrutiny?

"Proton Therapy (Radiation Therapy) is rated as a 3 in terms of safety by our team at Power. This is due to the fact that this therapy is currently in Phase 3 trials, signifying that while there is data supporting efficacy, there are also multiple rounds of data supporting safety."

Answered by AI

How many individuals are participating in this research project?

"That is correct. The clinical trial was originally posted on 6/22/2017 and was updated most recently on 8/11/2022. At the moment, the trial is looking for 186 individuals who are willing to participate at 17 different locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Radiation Therapy With Protons or Photons in Treating Patients With Liver Cancer

2017. "Radiation Therapy With Protons or Photons in Treating Patients With Liver Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03186898.

All > Liver Cancer > Hepatocellular Carcinoma