← Back to Search

Monoclonal Antibodies

Cisplatin-IMRT for Squamous Cell Carcinoma ((UPCI)13-056 Trial)

Phase 2

Recruiting

Led By Heath Skinner, MD

Research Sponsored by Christopher Wilke

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 up to 5 years

Awards & highlights

(UPCI)13-056 Trial Summary

This trial is testing which chemotherapy combo is more effective for treating HNSCC, as well as the side effects of the combos.

Who is the study for?

This trial is for adults with advanced head and neck squamous cell carcinoma (HNSCC) without distant metastasis. They must have stage III, IVa or IVb disease, be untreated by surgery for their current diagnosis, and not have had chemotherapy or radiation for HNSCC before. Those with a second HNSCC more than 2 years apart treated only by surgery are eligible; however, those with simultaneous primaries or bilateral tumors (except certain cases) cannot join.Check my eligibility

What is being tested?

The study compares the effectiveness of two chemotherapy combinations in treating locally advanced HNSCC: one group receives IMRT with cisplatin while the other gets IMRT combined with docetaxel and cetuximab. Participants will be sorted based on HPV status and ERCC-1 levels in their tumor to see which treatment works best relative to these factors.See study design

What are the potential side effects?

Possible side effects include reactions related to radiation therapy such as skin irritation and fatigue, as well as chemotherapy-related issues like nausea, vomiting, hair loss, low blood counts leading to increased infection risk or bleeding problems.

(UPCI)13-056 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

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

Time To Progression (TTP)

Secondary outcome measures

2-year (Time to Progression) TTP

Disease Related Blame Scale (DBS)

FACT-H&N FACT - Head & Neck

+12 more

(UPCI)13-056 Trial Design

2Treatment groups

Active Control

Group I: Cisplatin-IMRTActive Control2 Interventions

Cisplatin 40 mg/m2 weekly x 7; IMRT: once daily, M-F, 7 weeks (70 Gy)

Group II: Docetaxel-Cetuximab-IMRTActive Control3 Interventions

Docetaxel 15 mg/m2 weekly x 7; Cetuximab 400 mg/m2 load, one week prior to IMRT; Cetuximab 250 mg/m2 weekly x 7; IMRT: once daily, M-F, 7 weeks (70 Gy)

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Christopher WilkeLead Sponsor

1 Previous Clinical Trials

24 Total Patients Enrolled

Heath SkinnerLead Sponsor

3 Previous Clinical Trials

206 Total Patients Enrolled

Heath Skinner, MDPrincipal Investigator - University of Pittsburgh

Magee-Women's Hospital of UPMC, Radiologic Consultants Ltd, UPMC McKeesport, UPMC Passavant-McCandless, UPMC Presbyterian, UPMC Shadyside, UPMC St. Margaret

West Virginia University School Of Medicine (Medical School)

1 Previous Clinical Trials

16 Total Patients Enrolled

Frequently Asked Questions

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

What medical conditions are typically addressed with the combination therapy of Cisplatin and IMRT?

"The treatment regimen involving Cisplatin-IMRT is valuable in managing metastatic bladder cancer. It also shows promise in addressing advanced directives, small cell lung cancer, and advanced testicular cancer."

Answered by AI

Can you provide information on previous research studies using Cisplatin-IMRT?

"Currently, there are 313 active investigations exploring the combination of Cisplatin and IMRT, with a substantial portion (114 trials) in Phase III. Although numerous studies on this treatment approach are based in Zhuhai, Guangdong, a vast network of 6949 sites worldwide is involved in researching Cisplatin-IMRT."

Answered by AI

What is the overall participant count in this clinical study?

"Recruitment for this clinical study has ceased. The trial was first shared on 12/1/2013 and last revised on 4/7/2020. For individuals interested in other research opportunities, there are currently 2663 active trials seeking participants with squamous cell carcinoma and 313 ongoing studies focusing on Cisplatin-IMRT actively enrolling volunteers."

Answered by AI

What risks are associated with the administration of Cisplatin-IMRT in individuals?

"Our team at Power has assessed the safety of Cisplatin-IMRT to be a 2 on the scale, reflecting the Phase 2 trial status. At this stage, there is existing data supporting its safety profile but not yet confirming its efficacy."

Answered by AI

Are researchers currently enrolling participants for this medical study?

"At present, there are no ongoing patient recruitments for this particular research. The clinical trial was initially published on December 1st, 2013 and last revised on April 7th, 2020. For those interested in exploring other opportunities, there are currently a total of 2663 active clinical trials seeking participants with squamous cell carcinoma and another 313 studies focused on Cisplatin-IMRT actively enrolling patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Radiotherapy With Cisplatin vs. Docetaxel-cetuximab in HNSCC: ERCC1 Biomarker Enrichment and Interaction Design

Christopher Wilke 2013. "Radiotherapy With Cisplatin vs. Docetaxel-cetuximab in HNSCC: ERCC1 Biomarker Enrichment and Interaction Design". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02128906.

All > Hnscc > Squamous Cell Carcinoma