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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04849377
Recruitment Status : Withdrawn (lack of eligible participants due to change in study criterias)
First Posted : April 19, 2021
Last Update Posted : July 7, 2022
Sponsor:
Information provided by (Responsible Party):
Marshall Posner, MD, Icahn School of Medicine at Mount Sinai

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Human Papillomavirus (HPV) Head and Neck Squamous Cell Carcinoma (HNSCC) Radiation: RT 50 Gy Radiation: RT 54 GY Radiation: RT 60 GY Other: Induction Therapy Drug: Carboplatin Drug: Cisplatin 200 Drug: Cisplatin 240 Phase 2

Detailed Description:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: 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
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: RBD-HPV: Risk-Based De-Intensification for HPV+ HNSCC
Actual Study Start Date : June 14, 2022
Actual Primary Completion Date : June 14, 2022
Actual Study Completion Date : June 14, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group I - 50 Gy/200 mg/m2
Patient Characteristics: <20 Pack-Years, HPV16, OP, T1,T2 N0 RT 5 days per week for 6 weeks and Cisplatin weekly for 5 weeks
Radiation: RT 50 Gy
Radiation Therapy (RT) 50 GY
Other Name: Radiation Therapy

Drug: Cisplatin 200
200 mg/m2

Experimental: Group II - 54 Gy/200mg/m2
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
Radiation: RT 54 GY
Radiation Therapy (RT) 54 GY
Other Name: Radiation Therapy

Drug: Cisplatin 200
200 mg/m2

Experimental: Group III - 60 Gy/240 mg/m2
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
Radiation: RT 60 GY
Radiation Therapy (RT) 60 GY
Other Name: Radiation Therapy

Drug: Cisplatin 240
240mg/m2

Experimental: Group IV - TPF Induction followed by 60 Gy and Carboplatin AUC 1.5
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.
Radiation: RT 60 GY
Radiation Therapy (RT) 60 GY
Other Name: Radiation Therapy

Other: Induction Therapy
Induction Therapy: Cisplatin, Docetaxel, Fluorouracil

Drug: Carboplatin
Carboplatin AUC 9.0

Drug: Cisplatin 240
240mg/m2




Primary Outcome Measures :
  1. Rate of Locoregional control (LRC) [ Time Frame: 2 years ]
    The rate of locoregional control (LRC) at 2 years - Local regional control means no recurrence of the cancer in the head or neck area.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Patients must meet the following inclusion criteria to be eligible for enrollment in RBD-HPV:

  1. Histologically-confirmed squamous cell carcinoma of the head and neck, including subsites of the oropharynx, hypopharynx, larynx, and nasopharynx (with data on EBV)
  2. P16+ positivity as measured by IHC in a lab that is verified by the central laboratory or if the slides are available for review by the central laboratory
  3. HPV positivity by PCR assessed with either tissue or cytology in the central laboratory
  4. Stages I, II, III, or IV according to the AJCC 7th edition without evidence of distant metastases
  5. Age > 18
  6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  7. Adequate marrow function as defined by the following parameters:

    • Neutrophil count > 1.5 x 109/l
    • Platelet count > 100 x 109/l
    • Hemoglobin > 10 g/dl
  8. Adequate renal function as defined by a creatinine clearance > 60 ml/min (actual or calculated by the Cockcroft-Gault equation)
  9. Adequate liver function as defined by the following parameters:

    • Total bilirubin < institutional upper limit of normal (ULN) (except patients with Gilbert's Syndrome who have no other liver disease or abnormal liver serologies)
    • AST or ALT and alkaline phosphatase within the ranges described below
  10. A negative pregnancy test within 7 days of starting therapy in women of childbearing potential
  11. Capacity to understand the study protocol
  12. Willingness to provide written consent.

Exclusion Criteria: Patients will not be eligible for enrollment in this study if they exhibit any of the following conditions:

  1. Women who are currently pregnant or breast-feeding
  2. Men or women of childbearing potential who are not using adequate contraception during treatment and at least 3 months after therapy
  3. Current or prior malignancy in the last 5 years (excluding basal or squamous cell carcinoma of the skin not requiring systemic or radiation therapies, or prostate CA that is well-controlled and observed, etc)
  4. Radiation therapy for prior malignancy (except radioactive iodine for thyroid cancer)
  5. Prior chemotherapy for other malignancy or autoimmune disease
  6. Metastatic disease at presentation
  7. Nasal cavity subsite
  8. Active smoking (defined as > 1 cigarette per day within the last five years) or former smoking (has to have quit > 10 years ago) with a cumulative pack year history > 40 pack years
  9. Prior radiation therapy or chemotherapy for HNSCC (prior surgery alone is permitted)
  10. Active substance use disorder (ETOH or drugs, excluding marijuana)
  11. Prior use of IV drugs
  12. Significant peripheral neuropathy (> grade 2 according to NCI CTC)
  13. Prior hematologic or solid organ transplant
  14. Major medical comorbidity including:

    • Significant cardiovascular disease.
    • Significant neurologic disorder, including dementia and seizures.
    • Significant psychiatric disorder.
    • Active infection that is uncontrolled.
    • PUD (peptic ulcer disease) that is clinically active or unhealed.
    • Hypercalcemia.
    • COPD with hospitalization in the last 12 months for pneumonia or respiratory failure.
    • Interstitial lung disease.
    • Autoimmune disease requiring therapy.
    • Uncontrolled HIV infection (not on HAART, CD4 < 200).
    • Active Hepatitis C (+ RNA).
  15. Enrollment in a therapeutic clinical trial within 30 days of study entry
  16. Concurrent treatment with any other antineoplastic therapy
  17. Significant weight loss (> 25% of TBW) in the 2 months prior to study entry
  18. Patient has a history of non-adherence to medical care
  19. Patient will not be able to engage in comprehensive follow-up at Mount Sinai.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04849377


Locations
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United States, New York
Mount Sinai Hospital
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Marshall Posner, MD Ichan School of Medicine at Mount Sinai Hospital
Publications:

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Responsible Party: Marshall Posner, MD, Professor of Medicine, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT04849377    
Other Study ID Numbers: GCO 21-0525
First Posted: April 19, 2021    Key Record Dates
Last Update Posted: July 7, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All of the individual participant data collected during the trial, after deidentification.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marshall Posner, MD, Icahn School of Medicine at Mount Sinai:
Loco Regional Control (LRC)
Risk-based De-intensified chemoradio therapy (CRT)
Additional relevant MeSH terms:
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Squamous Cell Carcinoma of Head and Neck
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Cisplatin
Carboplatin
Antineoplastic Agents