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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

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Head and Neck Squamous Cell Carcinoma (HNSCC) include radiation therapy, chemotherapy, and surgery. Radiation therapy works by damaging the DNA of cancer cells, which inhibits their ability to replicate and leads to cell death. Chemotherapy, such as cisplatin, interferes with the DNA replication process, causing cell death and preventing tumor growth. Surgery involves the physical removal of cancerous tissue. De-escalated treatment approaches, which reduce the radiation dose and chemotherapy intensity, aim to minimize the severe side effects associated with these treatments while still effectively controlling the cancer. This is particularly important for HNSCC patients as it can improve their quality of life and reduce long-term complications without compromising the treatment's efficacy.
Role of Treatment Deintensification in the Management of p16+ Oropharyngeal Cancer: ASCO Provisional Clinical Opinion.

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,944 Previous Clinical Trials
589,715 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
~21 spots leftby Mar 2027