Multimodality Therapy for Head and Neck Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: UNC Lineberger Comprehensive Cancer Center

Must not be taking: Prohibited medications

Disqualifiers: Metastatic disease, Active infection, 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

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that you cannot use certain prohibited medications during treatment with lapatinib, so it's best to discuss your current medications with the study team.

What data supports the effectiveness of the treatment for head and neck cancer?

Research shows that combining paclitaxel and cisplatin with radiation therapy is promising for treating head and neck cancer, with studies indicating improved survival rates and effectiveness compared to radiation alone. ^{1 2 3 4 5}

Is the multimodality therapy for head and neck cancer safe?

The treatment involving paclitaxel and cisplatin with radiation has shown some promise, but main side effects remain a major problem, indicating potential safety concerns. ^{1 6 7 8 9}

What makes the multimodality therapy for head and neck cancer unique?

This treatment is unique because it combines multiple approaches, including surgery, radiation, and chemotherapy with drugs like cisplatin and paclitaxel, which are known to enhance the effects of radiation and improve local tumor control. The use of taxanes like paclitaxel offers an alternative to traditional platinum-based therapies, potentially reducing toxicity and overcoming resistance issues. ^{1 2 7 10 11}

What is the purpose of this trial?

The purpose of this study is to see if a three method risk adapted design using induction chemotherapy, transoral surgery and radiation chemotherapy will lessen toxic effects and make treatment of squamous cell carcinoma of the head and neck (SCCHN) better.

Research Team

Jared Weiss, MD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

Adults over 18 with previously untreated squamous cell carcinoma in the oral cavity, oropharynx, or larynx that can be removed by transoral surgery. Participants must have good liver and kidney function, acceptable blood counts, normal heart function, and agree to use contraception. Excluded are those with metastatic disease, recent major surgery recovery issues, serious infections or conditions that could risk safety or trial goals.

Inclusion Criteria

My heart's pumping ability is within the normal range.

I agree to use birth control during the study.

My blood tests show I have enough white blood cells, hemoglobin, and platelets.

Exclusion Criteria

My cancer has spread to other parts of my body.

I am not a candidate for the chemotherapy drugs in the initial treatment plan.

My cancer is in an early stage and has not spread to lymph nodes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Chemotherapy

Neoadjuvant induction with weekly carboplatin and paclitaxel in combination with daily lapatinib for 6 weeks

6 weeks

Surgery

Transoral surgery for squamous cell carcinoma of the head and neck

1 week

Post-operative Treatment

Risk-adapted treatment: no further treatment, ipsilateral radiation with weekly chemotherapy, or cisplatin with bilateral radiation based on risk category

11 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 months

Treatment Details

Interventions

• Bilateral Radiation
• Cisplatin
• Ipsilateral Radiation
• Lapatinib
• Paclitaxel
• Transoral Surgery

Trial Overview The study tests a combination of treatments for head and neck cancer: starting with chemotherapy drugs (Cisplatin/Carboplatin/Paclitaxel), followed by minimally invasive mouth/throat surgery and radiation therapy (Ipsilateral/Bilateral Radiation). Some may receive Lapatinib. The goal is to reduce side effects while improving treatment outcomes.

Participant Groups

Group I: Non-Randomized Single-Arm Experimental Treatment 7 Interventions

All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

GlaxoSmithKline

Industry Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Findings from Research

In a phase II study involving 23 patients with head and neck cancer, the combination of paclitaxel and cisplatin resulted in a partial response rate of 32% among evaluable patients, indicating some efficacy.

Despite the observed responses, the significant toxicity, including high rates of asthenia (56%) and other side effects, suggests that this chemotherapy regimen may not be suitable for palliative treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biweekly paclitaxel and cisplatin in patients with advanced head and neck carcinoma. A phase II trial. Licitra, L., Capri, G., Fulfaro, F., et al.[2020]

In a phase II trial involving 32 patients with advanced head and neck cancer, the aggressive combination of cisplatinum and paclitaxel with hyperfractionated-accelerated radiotherapy resulted in a 5-year overall survival rate of 48% and a disease-free survival rate of 43%.

While the treatment showed promising response rates, with 69% achieving a complete response, it was associated with significant acute toxicities, including high rates of grade 3 mucositis (71%) and erythema (28%), indicating the need for extensive supportive care during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II trial of a simultaneous radiochemotherapy with cisplatinum and paclitaxel in combination with hyperfractionated-accelerated radiotherapy in locally advanced head and neck tumors. Kuhnt, T., Becker, A., Bloching, M., et al.[2022]

Patients with locally advanced oropharyngeal squamous cell carcinoma who received cisplatin (CDDP) had a significantly better 2-year overall survival rate compared to those treated with cetuximab (CTX), with a hazard ratio of 1.68 indicating higher mortality for CTX users.

Cisplatin also resulted in lower overall treatment costs compared to CTX and carboplatin, despite higher rates of antiemetic use and hospital visits for side effects, suggesting it may be a more cost-effective option for treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing outcomes of concurrent chemotherapy regimens in patients 65 years old or older with locally advanced oropharyngeal carcinoma. Amini, A., Eguchi, M., Jones, BL., et al.[2023]

References

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

Radiosensitization in head and neck cancer: do we have an alternative to platins? Role of taxanes. [2014]

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

An initial experience using concurrent paclitaxel and radiation in the treatment of head and neck malignancies. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Biweekly paclitaxel and cisplatin in patients with advanced head and neck carcinoma. A phase II trial. [2020]

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

Phase II trial of a simultaneous radiochemotherapy with cisplatinum and paclitaxel in combination with hyperfractionated-accelerated radiotherapy in locally advanced head and neck tumors. [2022]

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

Favorable survival observed after carboplatin, paclitaxel, and concurrent accelerated hyperfractionated radiotherapy for treatment of locally advanced head and neck carcinoma. [2022]

6. Ireland pubmed.ncbi.nlm.nih.gov

Paclitaxel, cisplatin, 5-fluorouracil and radiotherapy in the management of advanced squamous cell carcinoma of the head and neck: a phase II trial. [2015]

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

Hydroxyurea with continuous infusion paclitaxel, 5-fluorouracil, and concomitant radiotherapy for poor-prognosis head and neck cancer. [2015]

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

Continuous infusion paclitaxel, 5-fluorouracil, and hydroxyurea with concomitant radiotherapy in patients with advanced or recurrent head and neck cancer. [2015]

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

Comparing outcomes of concurrent chemotherapy regimens in patients 65 years old or older with locally advanced oropharyngeal carcinoma. [2023]

10. India pubmed.ncbi.nlm.nih.gov

Concomitant cisplatin and radiationtherapy in advanced head and neck cancers:. [2021]

11. Germany pubmed.ncbi.nlm.nih.gov

[Preoperative radiochemotherapy of advanced resectable cancer of the oral cavity with cisplatin vs paclitaxel/carboplatin. Analysis of two multimodality treatment concepts]. [2018]