Reduced Chemoradiation for Head and Neck Cancer

Recruiting at 7 trial locations

Overseen By Zeinab Abou Yehia, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: T4 or N3, Prior radiotherapy, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for treating head and neck cancer using less intense radiation and chemotherapy, followed by surgery. The goal is to determine if this gentler approach can still effectively combat the cancer. Participants must have specific types of head and neck cancer, with no prior treatment, and visible cancerous lymph nodes on a scan. The trial uses carboplatin (a chemotherapy drug) and chemoradiation therapy to assess the effectiveness of this approach in managing the cancer. As a Phase 2 trial, this research measures how well the treatment works in an initial, smaller group, offering participants a chance to contribute to potentially groundbreaking cancer treatment advancements.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that carboplatin is generally well-tolerated for treating squamous cell carcinoma of the head and neck, with serious side effects being rare. For instance, one study found only one case of a severe drop in white blood cells. Some patients reported mild nerve damage and minor blood issues.

Chemoradiation therapy, which combines chemotherapy and radiation, is also used for head and neck cancer and has been safely administered to both older and younger patients. While it can cause side effects like nausea and tiredness, these are often manageable.

Overall, both treatments have been tested in various settings and demonstrate a good safety record, making them promising options for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatment approach for head and neck cancer because it aims to reduce the intensity of traditional chemoradiation therapy. Unlike the standard care that often involves high doses of radiation, this strategy combines a de-escalated dose of radiation with two cycles of standard chemotherapy, specifically using carboplatin. This approach targets patients with hypoxia-negative squamous cell carcinoma, potentially minimizing side effects while maintaining effectiveness. By focusing on patients who do not show hypoxia in their cancer cells, identified through advanced imaging, the treatment could offer a more tailored and less toxic option for managing the disease.

What evidence suggests that this treatment might be an effective treatment for head and neck cancer?

In this trial, participants with squamous cell carcinoma of the head and neck will receive a treatment regimen involving carboplatin with radiation therapy. Research has shown that this combination can help control head and neck cancer and improve survival rates. Studies have found that it is generally well-tolerated and works as well as other treatments. For patients unable to take cisplatin, carboplatin serves as a good alternative. Concurrent chemoradiation, which uses chemotherapy and radiation simultaneously, has effectively treated squamous cell carcinoma of the head and neck. This method controls the cancer while allowing patients to manage side effects. Overall, both carboplatin and concurrent chemoradiation show promise in fighting head and neck cancer. ^{1 3 6 7 8}

Who Is on the Research Team?

Zeinab Abou Yehia, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My cancer is localized and has not spread to distant parts of my body.

My kidneys are working well.

My throat cancer or unknown primary cancer is P16 negative.

Exclusion Criteria

Pregnant or breastfeeding

Severe, active co-morbidities

I have cancer in areas other than the back of my throat.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation and Chemotherapy

Participants receive de-escalated radiation therapy concurrent with 2 cycles of standard of care chemotherapy

8-12 weeks

Surgery

Planned neck dissection surgery to assess pathological response

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months

What Are the Treatments Tested in This Trial?

Interventions

• Carboplatin
• Chemoradiation therapy

Trial Overview 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.

How Is the Trial Designed?

Group I: Participants with Squamous Cell Carcinoma Head and Neck Cancer Experimental Treatment 3 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

Carboplatin is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Paraplatin for:

• Ovarian cancer
• Testicular cancer
• Lung cancer
• Head and neck cancer
• Brain cancer

Approved in European Union as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

Higher T and N stages in head and neck cancer are associated with lower rates of complete local control and survival, highlighting the need for improved treatment strategies.

Combined-modality treatments, such as induction chemotherapy followed by radiotherapy, show promise in enhancing survival and preserving organ function compared to aggressive surgery or radiotherapy alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined modalities in the treatment of head and neck cancers. Aisner, J., Hiponia, D., Conley, B., et al.[2015]

In a study of 20 patients with inoperable stage III and IV oral or oropharyngeal cancers, the combination of carboplatin and radiation therapy resulted in a 60% complete remission rate, indicating significant efficacy in treating these advanced cancers.

The treatment was well tolerated, with only 2 patients experiencing severe side effects that required interruptions, suggesting that carboplatin can be safely integrated into chemoradiation regimens for head and neck cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simultaneous radiochemotherapy in the treatment of inoperable, locally advanced head and neck cancers. Awasthy, BS., Julka, PK., Rath, GK., et al.[2013]

In a study of 2901 patients with locally advanced head and neck squamous cell carcinoma, low-dose cisplatin (LDC) showed similar overall survival rates compared to high-dose cisplatin (HDC), suggesting that LDC can be an effective alternative.

HDC was linked to a higher risk of severe side effects, including acute kidney injury and neutropenia, indicating that using LDC may reduce treatment-related toxicity while maintaining patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cisplatin Every 3 Weeks Versus Weekly With Definitive Concurrent Radiotherapy for Squamous Cell Carcinoma of the Head and Neck. Bauml, JM., Vinnakota, R., Anna Park, YH., et al.[2020]

In a study of 31 patients with recurrent or metastatic head and neck cancer, carboplatin showed a 26% response rate (complete or partial responses) with a median duration of 4.5 months, indicating its potential effectiveness against advanced squamous-cell carcinoma.

Carboplatin demonstrated a different toxicity profile compared to cisplatin, with moderate bone marrow suppression being the main side effect, while avoiding nephrotoxicity and allowing for outpatient treatment, making it a safer option for patients with renal concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carboplatin (NSC-241-240): an active platinum analog for the treatment of squamous-cell carcinoma of the head and neck. Eisenberger, M., Hornedo, J., Silva, H., et al.[2017]

Concurrent chemotherapy and radiation significantly improve locoregional control and overall survival in head and neck cancer, as supported by multiple randomized studies and recent meta-analyses.

The article reviews various trial types, including single-agent and multiagent chemotherapy, and highlights the effectiveness of concurrent chemoradiation in both postoperative settings and previously radiated patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concurrent chemoradiation in the treatment of head and neck cancer. Haffty, BG.[2019]

Concurrent chemo-radiotherapy is the standard treatment for patients with locally advanced head and neck cancers, providing effective care for both surgically operated and non-surgically operable patients.

Weekly carboplatin can be safely and effectively used instead of the standard every-three-weeks cisplatin regimen during concurrent chemo-radiotherapy, resulting in fewer side effects while maintaining similar efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of concurrent chemo-radiotherapy in patients with head and neck cancers: a review. Al-Sarraf, MD.[2012]

In a phase II trial involving 25 patients with advanced head and neck cancer, carboplatin demonstrated clinical activity, with 24% of patients achieving an objective response, including two complete responses.

The drug was generally well-tolerated, with mild side effects such as nausea, vomiting, and myelosuppression, and no significant renal or neurologic toxicity reported, suggesting it may be a safe treatment option for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carboplatin, an active drug in advanced head and neck cancer. de Andres Basauri, L., Lopez Pousa, A., Alba, E., et al.[2013]

In a study of 22 patients with advanced head and neck cancer, the combination of carboplatin and radiotherapy was evaluated for toxicity, revealing that a carboplatin dose of 70 mg/m2 was acceptable, while 80 mg/m2 resulted in severe side effects.

Despite the small sample size, the treatment showed promising results with 10 complete responses and a median survival exceeding 67 weeks, suggesting potential efficacy of this combined therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I study of concurrent carboplatin and radiotherapy in previously untreated patients with stage III and IV head and neck cancer. Osoba, D., Flores, AD., Hay, JH., et al.[2019]

A meta-analysis of 5 studies involving 491 patients found no significant difference in response rates between cisplatin and carboplatin for treating squamous head and neck cancer.

Cisplatin showed a trend towards better systemic activity and a higher 5-year survival rate (30%) compared to carboplatin (27%), but both agents are considered viable treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Definitive chemoradiotherapy for squamous head and neck cancer: cisplatin versus carboplatin? A meta-analysis. Aguiar, PN., Tadokoro, H., da Silva, GF., et al.[2017]

In a study of 39 patients with locally advanced inoperable head and neck cancer, the combination of carboplatin and radiation resulted in a high complete response (CR) rate of 59%, indicating effective local control of the disease.

While the treatment showed promising efficacy, it also led to significant side effects, with 60% of patients experiencing severe myelotoxicity, highlighting the need for careful monitoring and further research to confirm the benefits over radiation alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation and concurrent carboplatin administration in locally advanced head and neck cancer. A Hellenic Cooperative Oncology Group Study. Fountzilas, G., Skarlos, D., Nikolaou, A., et al.[2022]

In a study of 54 patients with locally advanced squamous cell carcinoma of the head and neck treated with carboplatin-based chemoradiotherapy, the overall locoregional control rate was 50%, indicating a moderate effectiveness of this treatment approach.

The median overall survival was 40 months, with 3-year survival rates of 59% for stage III/IVa patients, suggesting that carboplatin can be a viable alternative to cisplatin for patients at high risk of adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Definitive chemoradiotherapy with carboplatin for squamous cell carcinoma of the head and neck. Nagasaka, M., Zaki, M., Issa, M., et al.[2019]

In a study of 25 patients with locally advanced squamous cell carcinoma of the head and neck who were ineligible for cisplatin, concurrent treatment with carboplatin and radiotherapy resulted in a 70% complete response rate and a median progression-free survival of 42.7 months.

The treatment was generally well-tolerated, with significant toxicities including oral mucositis (56%) and thrombocytopenia (34%), suggesting that carboplatin could be a viable alternative for patients unable to receive cisplatin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of concurrent carboplatin plus radiotherapy for locally advanced head and neck cancer patients ineligible for treatment with cisplatin. Hamauchi, S., Yokota, T., Onozawa, Y., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6853181/

Definitive Chemoradiotherapy With Carboplatin for ... Definitive CRT with carboplatin for locally advanced squamous cell carcinoma of the head and neck was well tolerated and demonstrated comparable results to CRT ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10340068/

Chemoradiation with Cisplatin vs. Carboplatin for ... Given the limitations of this study, carboplatin appears a reasonable option for patients who require chemoradiation but cannot receive cisplatin. Abstract.

3. withpower.com withpower.com/trial/phase-2-head-and-neck-neoplasms-8-2022-81559

Reduced Chemoradiation for Head and Neck Cancer Research shows that using carboplatin with radiation therapy can help control head and neck cancer and improve survival rates, especially for patients who ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1808869425000199

Definitive treatment in squamous cell carcinoma of head ... A total of 233 patients underwent treatment with RT plus weekly or every three weeks Cisplatin (CDDP) or Carboplatin (Carbo). Toxicity and response to ...

5. redjournal.org redjournal.org/article/S0360-3016(23)08025-2/fulltext

A Multicenter Evaluation of Different Chemotherapy ... A multicenter evaluation of different chemotherapy regimens in older adults with head and neck squamous cell carcinoma undergoing definitive chemoradiation.

6. ascopubs.org ascopubs.org/doi/10.1200/jco.2006.24.18_suppl.15534

Safety and efficacy of the combination carboplatin ... Toxicity was mild: we recorded 1 case of G3 toxicity (neutropenia) and no G4 side effects. Three pts experienced G1–2 neuropathy and 4 pts G1–2 hematologic ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40569627/

Radiotherapy With Cisplatin vs Carboplatin Paclitaxel for ... The results of this study suggest that there were no differences in LRFS, PFS, DMFS, and OS in patients with SCCHN receiving radiotherapy ...

8. go.drugbank.com go.drugbank.com/drugs/DB00958/clinical_trials?conditions=DBCOND0035874&phase=3&purpose=treatment&status=completed

Carboplatin Completed Phase 3 Trials for Squamous Cell ... Carboplatin Completed Phase 3 Trials for Squamous Cell Carcinoma of the Head and Neck (SCCHN) Treatment ; NCT00609284. Randomized Trial of Concomitant ...