What side effects are associated with this type of intervention?

Common side effects of de-escalated radiation and chemotherapy for Head and Neck Squamous Cell Carcinoma include reduced long-term toxicities compared to standard treatments. Specifically, reduced radiation doses have been associated with lower rates of severe late adverse events, such as dysphagia (difficulty swallowing) and xerostomia (dry mouth). Cisplatin, a common chemotherapy agent, can cause acute toxicities like nausea, vomiting, and nephrotoxicity (kidney damage), but weekly dosing has shown a better toxicity profile compared to bolus dosing. Overall, de-escalated treatments aim to maintain efficacy while minimizing these side effects, leading to better quality of life and functional outcomes for patients.

What prior FDA approvals exist?

The FDA has approved several treatments for Head and Neck Squamous Cell Carcinoma (HNSCC) that align with the approach of reducing side effects while maintaining efficacy. Cetuximab, an EGFR-targeting monoclonal antibody, has been approved for use with radiation therapy, showing significant improvements in locoregional control and overall survival. Additionally, cisplatin-based chemoradiation is a standard treatment, although recent studies have explored de-escalation strategies, such as reduced radiation doses and alternative chemotherapy agents like cetuximab, to minimize long-term toxicities. These de-escalation strategies are still under investigation in clinical trials to confirm their efficacy and safety.

What other types of research exist?

Promising novel alternatives to de-escalated radiation and chemotherapy for HNSCC patients include: 1) Transoral robotic surgery (TORS) combined with reduced-dose adjuvant radiotherapy, which has shown favorable outcomes in terms of functional preservation and reduced toxicity. 2) The use of immunotherapy agents such as pembrolizumab and nivolumab, which have demonstrated efficacy in recurrent or metastatic settings and are being explored in earlier stages. 3) The replacement of platinum-based chemotherapy with cetuximab in specific patient populations, although this approach requires careful patient selection due to mixed results in survival outcomes. These alternatives should be considered in the context of ongoing clinical trials and in consultation with a multidisciplinary medical team.

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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 tests a treatment for head and neck cancer that uses lower doses of radiation and chemotherapy, followed by surgery to remove lymph nodes. It aims to see if this approach is effective while causing fewer side effects.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2.5 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

~6120

Do I qualify?Apply below to find out

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

1,956 Previous Clinical Trials

595,520 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

~19 spots leftby Mar 2027

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