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Alkylating agents

Reduced Chemoradiation for Head and Neck Cancer

Phase 2
Recruiting
Led By Kaveh Zakeri, MD
Research Sponsored by Memorial Sloan Kettering 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 2.5 years
Awards & highlights

Study Summary

This trial will test a less intense radiation/chemotherapy treatment followed by surgery to see if it's effective against head and neck cancer.

Who is the study for?
This trial is for adults with specific head and neck squamous cell carcinoma (excluding certain types like nasopharyngeal or oral cavity cancers) who haven't had prior chemotherapy or radiation for it. They must have a good performance status, adequate organ function, no distant metastasis, and not be pregnant.Check my eligibility
What is being tested?
The study tests a reduced intensity of radiation and chemotherapy followed by neck dissection surgery in head and neck cancer patients. It aims to see how well the cancer responds to this less aggressive treatment approach.See study design
What are the potential side effects?
Potential side effects include those typical of chemoradiation therapy such as fatigue, nausea, hair loss, skin changes at the irradiated area, low blood counts leading to increased infection risk, kidney issues from Carboplatin, and possible complications from surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2.5 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
Therapeutic radiology procedure

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants with Squamous Cell Carcinoma Head and Neck CancerExperimental Treatment3 Interventions
Participants will be hypoxia-negative T0-3N1-2B small cell carcinoma head and neck cancer/SCC HNC patients (HPV-OPC, HPV- UPC with nodal metastasis(es), HPC, or LXC) who are eligible for definitive CRT with de-escalated radiation concurrent with 2 cycles of SOC chemotherapy. Hypoxia status will be determined by the absence of hypoxia radiotracer uptake on 18F-FMISO PET/CT imaging
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6670

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,853 Total Patients Enrolled
Kaveh Zakeri, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
100 Total Patients Enrolled

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05544136 — Phase 2
Head and Neck Squamous Cell Carcinoma Research Study Groups: Participants with Squamous Cell Carcinoma Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT05544136 — Phase 2
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05544136 — 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 still opportunities to participate in this experiment?

"The details posted on clinicaltrials.gov indicate that this medical experiment is actively looking for participants; it was initially announced on September 12th 2022 and has been updated most recently on September 21st 2022."

Answered by AI

How many locations are currently engaged in this research endeavor?

"This trial is actively running at 6 different clinical sites, ranging from Harrison to Basking Ridge and several other cities. To minimize travel requirements if you join the study, it would be prudent to select a centre near your current residence."

Answered by AI

How many individuals are engaged in this research endeavor?

"Affirmative. The clinicaltrials.gov database suggests that this experiment is seeking volunteers, which was first published on September 12th 2022 and more recently updated on the 21st of the same month. It requires 36 participants recruited from 6 different sites to complete it."

Answered by AI

To what degree is Chemoradiation therapy a secure option for patients?

"Although there is some evidence that Chemoradiation therapy exhibits safety, the lack of efficacy data leads to a score of 2."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Decreasing Radiation Therapy and Chemotherapy in People With Head and Neck Cancer
2022. "A Study of Decreasing Radiation Therapy and Chemotherapy in People With Head and Neck Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05544136.
~23 spots leftby Mar 2027
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