Neoplasms

All Conditions

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Head and Neck Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Carboplatin

Fluorouracil

Cisplatin

Patient Characteristics: \<20 Pack-Years, HPV16, OP, T1,T2 N0 RT 5 days per week for 6 weeks and Cisplatin weekly for 5 weeks

Patient Characteristics: \<20 Pack-Years, HPV16, OP, T1-T2, N1-N2b, T3 N0-N2b RT 5 days per week for 6 weeks and Cisplatin weekly for 6 weeks

Patient Characteristics: 20-40 Pack-Years, Non-HPV16, Non-OP, T1-T2, N1-N2b, T3 N0-N2b RT 5 days per week for 6 weeks and Cisplatin weekly for 6 weeks

Patient Characteristics: 20-40 Pack-Years, Non-HPV16, Non-OP, T4, N2c, \>3 nodes, ENE, or Matted Nodes Induction Therapy: Cisplatin, Docetaxel, Fluorouracil followed by RT 60 GY + Carboplatin AUC 9.0 Docetaxel every 21 days for 3 cycles, Cisplatin every 21 days for 3 cycles, Fluorouracil continuous infusion over 4 days (every 21 days for 3 cycles). Followed by RT 5 days per week for 6 weeks and Carboplatin weekly for 6 weeks.

RT 50 Gy

RT 54 GY

RT 60 GY

Induction Therapy: Cisplatin, Docetaxel, Fluorouracil

Induction Therapy

Cisplatin 200

Cisplatin 240

Marshall Posner, MD

The purpose of this research study is to determine the rate of local regional control at 2 years when using de-intensified chemoradiotherapy (CRT) in patients with Human Papillomavirus (HPV)-associated head and neck squamous cell carcinoma (HNSCC). Local regional control means no recurrence of the cancer in the head or neck area. Study subjects will be enrolled into 4 groups. Group/treatment will be based on a number of factors, including smoking and drinking history.

The purpose of this research study is to determine the rate of local regional control at 2 years when using de-intensified chemoradiotherapy (CRT) in patients with Human Papillomavirus (HPV)-associated head and neck squamous cell carcinoma (HNSCC). Local regional control means no recurrence of the cancer in the head or neck area. Study subjects will be enrolled into 4 groups. Group/treatment will be based on a number of factors, including smoking and drinking history.

If participants choose to participate, participants will be asked to:

* Participate in screening for eligibility, this will include: questions regarding \\medical history, physical exam, blood/urine samples, electrocardiogram, PET/CT and/or CT-MRI of the neck, assessment of tumor, and a questionnaire.
* Complete the study regimen including evaluations and follow up visits. Participants may be in this research study for approximately to 5 years after receiving standard of care (SOC) treatment. Depending on the group enrolled in, the treatment will last either 6 weeks (Groups 1-3) or 15 weeks (Group 4.This group will also receive 3 cycles of SOC induction therapy (One cycle = 21 days). Induction therapy is initial chemotherapy delivered prior to radiation or surgery when treating cancer.
* Participate in routine types of procedures such as clinical exams, blood and urine tests, and imaging tests to assess tumor.
* Consent to storage of research samples.

This research study involves chemotherapy and intensity-modulated radiation therapy (IMRT) IMRT is used to safely deliver precise radiation to a tumor while minimizing the dose to surrounding normal tissue.

There are no added costs associated with participation. There is no reimbursement for participation.

The names of the drugs/interventions involved in this study are:

* Cisplatin
* Docetaxel (Group 4 only)
* Fluorouracil (Group 4 only)
* Carboplatin (Group 4 Only)

All of the drugs listed above are approved for use by the Food and Drug Administration (FDA), commercially available, and considered standard of care (SOC) for cancer.

Serious known side effects that participants may experience include:

* Nausea and vomiting
* Diarrhea
* Fever
* Skin irritation, rash
* Joint pain

CRT (Cisplatin with IMRT/IMPT): Group I 50 Gy/200 mg/m2, Group II 54 Gy/200 mg/m2, Group III 60 Gy/240 mg/m2 Sequential Therapy: Group IV TPF Induction followed by 60 Gy and Carboplatin AUC 1.5

RBD-HPV: Risk-Based De-Intensification for HPV+ HNSCC

All of the individual participant data collected during the trial, after deidentification.

The rate of locoregional control (LRC) at 2 years - Local regional control means no recurrence of the cancer in the head or neck area.

Spots Global Cancer Trial Database for cisplatin 240