A Pilot Study of Radiation and Chemotherapy De-Escalation for p16-Negative Oropharyngeal Cancer and p16-Negative or Positive Laryngeal and Hypopharyngeal Cancers

  • STATUS
    Recruiting
  • End date
    Mar 12, 2024
  • participants needed
    36
  • sponsor
    Memorial Sloan Kettering Cancer Center
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Updated on 11 October 2022
See if I qualify
ct scan
fluorouracil
metastasis
neutrophil count
carboplatin
primary tumor
neck dissection

Summary

The purpose of this study is to test the treatment approach of de-escalated radiation and chemotherapy followed by a planned neck dissection surgery in people with head and neck cancer. The study will look at how effective the treatment approach is against participants' cancer.

Details
Condition Head and Neck Cancer, Head and Neck Carcinoma, Head and Neck Neoplasms, Head and Neck Squamous Cell Carcinoma
Treatment carboplatin, Chemoradiation therapy, 18F-FMISO PET/CT scan
Clinical Study IdentifierNCT05544136
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on11 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Histologically confirmed diagnosis of SCC of the head and neck (excluding nasopharynx, nasal cavity/paranasal sinus, oral cavity, salivary, thyroid, and cutaneous primary malignancies)
Any unknown primary SCC of the head and neck with radiographically detectable gross nodes is allowed (core or excisional biopsy acceptable; if excisional biopsy is performed, there must be residual radiographically detectable nodal disease; FNA may be acceptable only with PI and/or co-PI approval)
If the primary site is oropharynx or unknown primary, P16 IHC must be negative
If the primary site is hypopharynx or larynx, any P16 status is acceptable (positive, negative, or unknown). P16 IHC is strongly encouraged when possible
Clinical stage T0-3 N1-2B M0 (AJCC 7th edition) without evidence of distant metastasis
based on staging FDG PET/CT
years of age or older
Must not have received prior radiation therapy or chemotherapy for HNC
Patients who have had their primary site tumor removed by surgery but still have residual grossly enlarged, radiographically detectable lymph nodes are eligible for this study
Karnofsky Performance Status (KPS) ≥ 70
CT or MRI of the Neck with and without contrast
Note: A CT scan of the Neck and/or a PET/CT performed for the purposes of radiation planning may serve as planning tools
Adequate hematologic function within 30 days prior to registration, defined as
follows
White Blood Count (WBC) ≥ 2,000 cells/µL
Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3
Platelets ≥ 100,000 cells/mm3
Hemoglobin ≥ 8.0 g/dL; Note: The use of transfusion or other interventions to achieve Hgb ≥ 8.0 g/dL is acceptable
Adequate renal function within 30 days prior to registration, defined as follows
Serum creatinine < 1.5 mg/dL or creatinine clearance (CrCl) ≥ 50 mL/min determined by 24-hour collection or estimated by Cockcroft-Gault formula: CrCl male = [(140 - age) x (weight in kg)] / [(Serum Cr mg/dL) x (72)] CrCl female = 0.85 x (CrCl male)
Patients with serum creatinine > 1.5 mg/dL can be eligible for carboplatin-based chemotherapy with approval of co-PI (Dr. Eric Sherman
Adequate hepatic function within 30 days prior to registration, defined as follows
Bilirubin < 2 mg/dL
AST or ALT < 3 x the upper limit of normal
Negative serum pregnancy test within 14 days prior to registration for women of
childbearing potential
The subject/legally authorized representative (LAR) must provide study-specific informed consent prior to study entry

Exclusion Criteria

All nasopharyngeal, nasal cavity/paranasal sinus, oral cavity, salivary gland, thyroid, and cutaneous primary malignancies
Any T4 or N3 patients
Any prior radiotherapy to the head and neck region
Any prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different non-H&N cancer is permissible
Prior chemotherapy or radiotherapy within the last three years
Patients who underwent previous surgical resection for the same disease (except for biopsy or surgery removing primary site tumor but still present with grossly enlarged, radiographically detectable lymph nodes)
Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 3 years or if cure rate from treatment at 5 years estimated to be ≥ 90%
Subjects with simultaneous primary cancers outside of the oropharynx
Note: Exceptions can be made for patients with simultaneous primaries outside the H&N if determined by the PI/Co-PI that the patient can proceed with protocol activities
Pregnant (confirmed by serum b-HCG in women of reproductive age) or breastfeeding
Severe, active co-morbidities defined as follows
Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
Transmural myocardial infarction within the last 6 months
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration
Hepatic Insufficiency resulting in clinical jaundice and/or coagulation defects
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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