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Alkylating agents

Chemotherapy and High-Dose Radiotherapy for Squamous Cell Carcinoma

Phase 1

Waitlist Available

Led By Ari Rosenberg

Research Sponsored by University of Chicago

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 5 years

Awards & highlights

Study Summary

This trial is testing whether blood tests can help predict how well head and neck cancer patients will respond to chemotherapy, and whether reducing additional treatment can lower side effects.

Eligible Conditions

Squamous Cell Carcinoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

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

Feasibility of collection of serial HPV-DNA blood samples in patients undergoing treatment for Oropharyngeal Squamous Cell Carcinoma

Relationship Between HPV-DNA Found in Participant's Blood and Participant Response to Chemotherapy

Secondary outcome measures

Changes in Blood Containing HPV-DNA During Response-Based Therapy

Distant Control

Locoregional Control

+4 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Induction Therapy (Carboplatin and Paclitaxel)Experimental Treatment2 Interventions

All study participants will be assigned to this group to first receive induction therapy using a combination of carboplatin and paclitaxel. Participant response to this phase of therapy will determine which group (low-risk, intermediate risk or high-risk) the participant will be in.

Group II: Group C - High-RiskExperimental Treatment1 Intervention

Participants who have high-risk cancer and less than a 50% reduction in their tumor size following induction therapy will be assigned to this group.

Group III: Group B - Intermediate RiskExperimental Treatment1 Intervention

Participants who have low-risk cancer and intermediate reduction (30-50%) in tumor size or high-risk cancer with significant reduction (greater than or equal to 50%) in tumor size following induction therapy will be assigned to this group.

Group IV: Group A - Low RiskExperimental Treatment1 Intervention

Participants who have low-risk cancer and significant reduction (greater than 50%) in tumor size following induction therapy will be assigned to this group.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5380

Carboplatin

2014

Completed Phase 3

~6670

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor

1,001 Previous Clinical Trials

817,680 Total Patients Enrolled

Ari RosenbergPrincipal InvestigatorUniversity of Chicago

Frequently Asked Questions

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

Is recruitment open for this research trial?

"Per clinicaltrials.gov, this research is currently enrolling participants. It was initially advertised on October 1st 2020 and the last update occurred in November 12th 2021."

Answered by AI

Is there precedent for integrating Chemotherapy and High-Dose Radiotherapy into a single research protocol?

"Currently, 1175 clinical trials are conducting research on Chemotherapy and High-Dose Radiotherapy. 332 of those studies have achieved Phase 3 status. Shanghai is the most common city for these experiments but 66530 locations worldwide are trialing this intervention."

Answered by AI

What overarching goals is this experiment hoping to accomplish?

"The chief outcome of this trial, which will be analyzed over a period of 16 weeks, assesses the relationship between HPV-DNA in patient blood and their response to chemotherapy. Secondary objectives encompass an evaluation of tumor reaction among those undergoing Transoral Robotic Surgery (TORS) post-treatment chemo; locoregional control - or number of participants who achieve localised control after treatment; and time until disease recurrence – as in length of time patients remain without evidence of relapse."

Answered by AI

What is the active participant count of this medical experiment?

"Affirmative. The corresponding clinical trial is actively seeking applicants, as per the data available on clinicaltrials.gov. This medical endeavour was first documented on October 1st 2020 and has been updated most recently on November 12th 2021; 36 patients are expected to be recruited from a single site for this study."

Answered by AI