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Radiation

Arm I (reduced > 95% of TTMV, external beam radiotherapy) for Squamous Cell Carcinoma

Phase 2

Recruiting

Led By Sujith Baliga

Research Sponsored by Ohio State University Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 2 years

Awards & highlights

Study Summary

"This trial aims to see if using a blood test to guide lower dose radiation therapy is effective in treating patients with HPV-related throat cancer. They want to compare the effects of this approach with standard chemotherapy in

Who is the study for?

This trial is for patients with HPV-associated oropharyngeal cancer. Participants must have detectable human papillomavirus in their blood and be suitable for chemotherapy combined with radiation therapy. Specific details on inclusion and exclusion criteria are not provided.Check my eligibility

What is being tested?

The study tests if lower dose radiation guided by circulating tumor DNA levels can effectively treat HPV-related oropharyngeal cancer, compared to standard higher dose radiation with chemotherapy. It involves questionnaires, PET/CT scans, biospecimen collection, and drugs like Carboplatin, Cisplatin, Paclitaxel.See study design

What are the potential side effects?

Potential side effects include those related to external beam radiation therapy (skin changes, fatigue, dry mouth) and chemotherapy (nausea, hair loss, increased risk of infection). The specific side effects will depend on the individual's reaction to treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 2 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

Positron emission tomography complete response

Secondary outcome measures

Incidence of adverse events

Progression free survival

Quality of life (QOL)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (reduced > 95% of TTMV, external beam radiotherapy)Experimental Treatment8 Interventions

Patients undergo external beam radiotherapy daily for 5 days a week for 4 weeks. Patients also receive cisplatin IV weekly or every 3 weeks or carboplatin/paclitaxel IV weekly at the discretion of treating physician for 4 weeks. Patients undergo blood sample collection for circulating tumor DNA testing at week 4. Patients with reduced > 95% of TTMV undergo external beam radiotherapy QD 5 days a week for 5 weeks. Patients also receive cisplatin IV weekly or every 3 weeks or carboplatin/paclitaxel IV weekly at the discretion of treating physician for 5 weeks. Patients also undergo blood sample collection during screening and throughout the trial.

Group II: Arm II (not reduced > 95% of TTMV, external beam radiotherapy)Active Control8 Interventions

Patients undergo external beam radiotherapy daily for 5 days a week for 4 weeks. Patients also receive cisplatin IV weekly or every 3 weeks or carboplatin/paclitaxel IV weekly at the discretion of treating physician for 4 weeks. Patients undergo blood sample collection for circulating tumor DNA testing at week 4. Patients without reduced > 95% of TTMV undergo external beam radiotherapy daily for 5 days a week for 7 weeks. Patients also receive cisplatin IV weekly or every 3 weeks or carboplatin/paclitaxel IV weekly at the discretion of treating physician for 7 weeks. . Patients also undergo blood sample collection during screening and throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5380

Biospecimen Collection

2004

Completed Phase 2

~1700

Carboplatin

2014

Completed Phase 3

~6670

Cisplatin

2013

Completed Phase 3

~1940

Computed Tomography

2017

Completed Phase 2

~2720

External Beam Radiation Therapy

2006

Completed Phase 3

~3070

Positron Emission Tomography

2008

Completed Phase 2

~2240

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor

320 Previous Clinical Trials

290,050 Total Patients Enrolled

Sujith BaligaPrincipal InvestigatorOhio State University Comprehensive Cancer Center

Frequently Asked Questions

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

Are new participants currently being accepted for enrollment in this ongoing medical study?

"Per information obtained from clinicaltrials.gov, this study is presently in the recruitment phase. The trial was initially posted on April 1st, 2024 and last modified on March 14th of the same year."

Answered by AI

Has Arm I, involving a significant reduction in TTMV and external beam radiotherapy, received approval from the FDA?

"Our team at Power has evaluated the safety of Arm I, involving a reduction of over 95% in TTMV alongside external beam radiotherapy, to be rated as 2. This rating aligns with it being a Phase 2 trial where there is existing data supporting its safety aspect without evidence backing efficacy yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Adaptive De-intensified Radiotherapy Using Circulating Tumor DNA in HPV- Associated Oropharyngeal Cancer

Sujith Baliga 2024. "Adaptive De-intensified Radiotherapy Using Circulating Tumor DNA in HPV- Associated Oropharyngeal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06323460.