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Radiation

De-intensified Radiotherapy for Oropharyngeal Cancer

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

No Placebo-Only Group

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Positron emission tomography complete response

Secondary study objectives

Incidence of adverse events

Progression free survival

Quality of life (QOL)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Cisplatin

2013

Completed Phase 3

~3120

Positron Emission Tomography

2011

Completed Phase 2

~2200