Reduced Chemoradiation for Head and Neck Cancer

Recruiting at 7 trial locations

Overseen By Nancy Lee, 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

Trial Summary

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.

What data supports the effectiveness of the treatment Carboplatin in 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 cannot undergo surgery. Studies have found that combining chemotherapy with radiation is more effective than radiation alone in treating advanced head and neck cancer. ^{1 2 3 4 5}

Is reduced chemoradiation with carboplatin safe for head and neck cancer patients?

Carboplatin, used in combination with radiotherapy for head and neck cancer, generally shows mild to moderate side effects like nausea, vomiting, and bone marrow suppression, but it avoids kidney and nerve damage often seen with similar treatments. It is considered safe for patients who cannot tolerate other treatments, though care is needed for those with kidney issues. ^{4 6 7 8 9}

How is the treatment with carboplatin and chemoradiation different for head and neck cancer?

This treatment uses carboplatin instead of the more commonly used cisplatin, which can be given weekly with radiation to reduce side effects while maintaining similar effectiveness. It offers a potentially more tolerable option for patients who cannot handle the standard high-dose cisplatin regimen. ^{1 2 10 11 12}

What is the purpose of this trial?

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.

Research Team

Nancy Lee, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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 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]

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]

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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Definitive chemoradiotherapy for squamous head and neck cancer: cisplatin versus carboplatin? A meta-analysis. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Radiation and concurrent carboplatin administration in locally advanced head and neck cancer. A Hellenic Cooperative Oncology Group Study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Definitive chemoradiotherapy with carboplatin for squamous cell carcinoma of the head and neck. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Combined modalities in the treatment of head and neck cancers. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Carboplatin, an active drug in advanced head and neck cancer. [2013]

7. United States 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. [2017]

8. England 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. [2018]

9. United States 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. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Cisplatin Every 3 Weeks Versus Weekly With Definitive Concurrent Radiotherapy for Squamous Cell Carcinoma of the Head and Neck. [2020]

11. Kuwait pubmed.ncbi.nlm.nih.gov

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

12. India pubmed.ncbi.nlm.nih.gov

Simultaneous radiochemotherapy in the treatment of inoperable, locally advanced head and neck cancers. [2013]