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Radiation Therapy + Cisplatin for Head and Neck Cancer

Phase 2

Recruiting

Led By Robert Ferris

Research Sponsored by ECOG-ACRIN Cancer Research Group

Eligibility Criteria Checklist

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

Must have

Pathologically proven diagnosis of squamous cell carcinoma of the head/neck (oral cavity, oropharynx, hypopharynx or larynx) at stage III or IVA

Patients with a history of a curatively treated malignancy must be disease-free for at least two years except for carcinoma in situ of cervix and/or non-melanomatous skin cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up date of randomization to the date of recurrence, second primary tumor from the head and neck region, or death, assessed up to 10 years

Awards & highlights

Study Summary

This trial is testing whether radiation therapy is more effective with or without cisplatin in treating patients with squamous cell carcinoma of the head and neck.

Who is the study for?

This trial is for adults with stage III-IVA squamous cell carcinoma of the head and neck who've had surgery. They should not have recurrent disease or multiple cancers, must be two years free from other cured cancers (except certain skin/cervix cancers), and can't have had prior radiation in the same area. Participants need proper kidney function, blood counts within normal ranges, no pregnancy or breastfeeding, and they must use contraception.Check my eligibility

What is being tested?

The study is examining if adding cisplatin to radiation therapy improves outcomes for patients post-surgery compared to radiation alone. It's a phase II trial where participants are randomly assigned to receive either both treatments or just radiation therapy.See study design

What are the potential side effects?

Radiation may cause skin irritation, fatigue, dry mouth/throat issues while cisplatin can lead to nausea, kidney problems, hearing changes and nerve damage. Side effects vary by individual.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is a type of squamous cell carcinoma in the head or neck, at stage III or IVA.

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I've been cancer-free for 2 years, except for certain skin cancers or cervical pre-cancer.

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My cancer has not come back or spread from its original site.

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My white blood cell count is healthy.

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I had surgery to completely remove my cancer with the goal of curing it.

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My oropharynx tumor is not caused by HPV.

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I haven't had radiation to my head or neck that would affect my current treatment area.

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I can send a tissue sample from my surgery to Foundation Medicine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ date of randomization to the date of recurrence, second primary tumor from the head and neck region, or death, assessed up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~date of randomization to the date of recurrence, second primary tumor from the head and neck region, or death, assessed up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and date of randomization to the date of recurrence, second primary tumor from the head and neck region, or death, assessed up to 10 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

Disease-free survival in patients with stage III-IV disease and disruptive p53 mutation

Secondary outcome measures

Disease-free survival in patients with stage III-IV disease and non-disruptive p53 mutation

Disease-free survival in patients with stage III-IV disease and wild type p53 mutation

Incidence of adverse events graded using Common Terminology Criteria for Adverse Events version 4

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B (IMRT, cisplatin)Experimental Treatment3 Interventions

Patients undergo IMRT QD 5 days a week and receive cisplatin IV over 1-2 hours weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.

Group II: Arm A (IMRT)Experimental Treatment2 Interventions

Patients undergo IMRT QD 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

2013

Completed Phase 3

~1940

Intensity-Modulated Radiation Therapy

2010

Completed Phase 3

~2160

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor

116 Previous Clinical Trials

176,733 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,665 Previous Clinical Trials

40,925,665 Total Patients Enrolled

Robert FerrisPrincipal InvestigatorECOG-ACRIN Cancer Research Group

2 Previous Clinical Trials

10,519 Total Patients Enrolled

Media Library

Intensity-Modulated Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT02734537 — Phase 2

Head and Neck Squamous Cell Carcinoma Research Study Groups: Arm A (IMRT), Arm B (IMRT, cisplatin)

Head and Neck Squamous Cell Carcinoma Clinical Trial 2023: Intensity-Modulated Radiation Therapy Highlights & Side Effects. Trial Name: NCT02734537 — Phase 2

Intensity-Modulated Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT02734537 — Phase 2

Frequently Asked Questions

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

Are there vacancies available to participants in this trial?

"Affirmative, the data on clinicaltrials.gov showcases that this medical research is still searching for participants. Initially posted on March 29th 2016, and most recently updated June 9th 2022, 189 patients between 100 sites are needed."

Answered by AI

What maladies can be alleviated through Cisplatin administration?

"Cisplatin is most popularly used to counter metastatic neoplasms, yet it may also be utilized in certain conditions such as advanced ovarian cancer that are unresponsive to traditional interventions."

Answered by AI

How many individuals have enrolled in this clinical experiment?

"Affirmative. Data on clinicaltrials.gov indicates that this experiment, which was first posted on March 29th 2016, is still enrolling participants. Currently 189 patients need to be recruited from 100 different locations."

Answered by AI

Has Cisplatin been sanctioned by the FDA?

"Due to a lack of supporting clinical evidence demonstrating its efficacy, Cisplatin has been provisionally rated with a score of 2 in terms of safety."

Answered by AI

What other research endeavours have been conducted which concern Cisplatin?

"Currently, 747 studies are underway assessing the efficacy of Cisplatin while 289 of those trials have made it to Phase 3. Most of these experiments are located in Shanghai but 44132 locations around the world host research into this therapeutic agent."

Answered by AI

How many locations is the implementation of this clinical trial taking place?

"100 medical centres are currently recruiting participants for this study. Among these locations include Livonia, Troy, and Boardman as well as other surrounding areas. For convenience's sake, it is recommended that prospective enrollees select the closest site to them in order to reduce travel demands."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III-IVA Squamous Cell Carcinoma of the Head and Neck Who Have Undergone Surgery

2016. "Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III-IVA Squamous Cell Carcinoma of the Head and Neck Who Have Undergone Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02734537.

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