Clinical Trials /

Major De-escalation to 30 Gy for Select Human Papillomavirus Associated Oropharyngeal Carcinoma

NCT03323463

Description:

The purpose of this study is to demonstrate that participants with HPV positive and hypoxia negative T1-2, N1-2c (AJCC, 7th ed.) oropharyngeal squamous cell carcinoma receiving a major de-escalated radiation therapy with 2 cycles of standard chemotherapy is not inferior to comparable subjects treated with the current standard chemoradiation. Given the restrictions of surgery during the COVID19 pandemic, we will start enrolling patients on Cohort B where surgery is not required. Once the COVI19 pandemic is over, we will resume and complete enrollment on Cohort A where surgery is required, prior to continuing enrolling patients on Cohort B. During the COVID-19 pandemic, the research MRIs are optional.

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma of Unknown Primary
  • Oropharyngeal Squamous Cell Carcinoma
  • Tonsillar Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Major De-escalation to 30 Gy for Select Human Papillomavirus Associated Oropharyngeal Carcinoma
  • Official Title: A Prospective Single Arm Non-inferiority Trial of Major Radiation Dose De-Escalation Concurrent With Chemotherapy for Human Papilloma Virus Associated Oropharyngeal Carcinoma (Major De-escalation to 30Gy for Select Human Papillomavirus Associated Oropharyngeal Carcinoma)

Clinical Trial IDs

  • ORG STUDY ID: 17-409
  • NCT ID: NCT03323463

Conditions

  • HPV-Associated Oropharyngeal Squamous Cell Carcinoma
  • Squamous Cell Carcinoma of the Neck

Interventions

DrugSynonymsArms
CisplatinHPV associated oropharyngeal carcinoma
CarboplatinHPV associated oropharyngeal carcinoma
5FluorouracilHPV associated oropharyngeal carcinoma

Purpose

The purpose of this study is to demonstrate that participants with HPV positive and hypoxia negative T1-2, N1-2c (AJCC, 7th ed.) oropharyngeal squamous cell carcinoma receiving a major de-escalated radiation therapy with 2 cycles of standard chemotherapy is not inferior to comparable subjects treated with the current standard chemoradiation.

Trial Arms

NameTypeDescriptionInterventions
HPV associated oropharyngeal carcinomaExperimentalHPV associated oropharyngeal carcinoma subjects who also have no evidence of hypoxia
  • Cisplatin
  • Carboplatin
  • 5Fluorouracil

Eligibility Criteria

        Inclusion Criteria:

        - Pathologically (histologically or cytologically) proven diagnosis of HPV associated
        squamous cell carcinoma of the oropharynx (tonsil, base of tongue, or oropharyngeal walls)
        from surgical resection or excisional biopsy regardless of margin status.

          -  Squamous cell carcinoma of the neck of unknown primary is allowed with excision biopsy
             of a lymph node (or core biopsy) and consent from the PI or co-PIs

               -  Subjects must have clinically or radiographically evident measurable disease at
                  nodal stations.

               -  Clinical stage T1-2, N1-2c without evidence of distant metastasis based on FDG
                  PET/CT.

          -  Patients who have squamous cell carcinoma of the neck of unknown primary, and thus,
             are T0, are allowed with excision biopsy of a lymph node (or core biopsy) or consent
             from the PI or co-PI

               -  CT or MRI of the neck with and without contrast Note: A CT scan of neck and/or a
                  PET/CT performed for the purposes of radiation planning may serve as planning
                  tools.

               -  ECOG Performance Status of 0-2

               -  Age ≥ 18

               -  Adequate hematologic function within 30 days prior to registration, defined as
                  follows:

          -  White Blood Count (WBC) >/= 2 K/mcL

          -  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 intervention 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 (CC) ≥ 50 ml/min determined by
             24-hour collection or estimated by Cockcroft-Gault formula

        CCr male = [(140 - age) x (wt in kg)] [(Serum Cr mg/dl) x (72)] CCr female = 0.85 x (CrCl
        male)

          -  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 must provide study-specific informed consent prior to study entry

        Exclusion Criteria:

          -  Subjects with prior head and neck radiation therapy

          -  Subjects with simultaneous primary cancers outside of the oropharynx

          -  Note: Exceptions can be made for patients with simultaneous primaries outside the
             oropharynx if determined by the PI/Co-PI the patient can proceed with protocol
             activities

          -  Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free
             for 3 years or if cure rate from treatment at 5 years to be 90% or greater

          -  Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a
             different cancer is allowable

          -  No particle therapy such as but not limited to proton therapy is allowed

          -  Severe, active co-morbidity 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Effectiveness of study treatment for participants receiving de-escalated radiation therapy radiation therapy, comparable to participants treated with the current standard of care chemoradiation by standard CT (or MRI) or tumor site and PET scan
Time Frame:2 years (+/- 3 months)
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Memorial Sloan Kettering Cancer Center

Trial Keywords

  • squamous cell carcinoma of the neck of unknown primary
  • HPV-Associated Oropharyngeal Squamous Cell Carcinoma
  • Oropharyngeal Squamous Cell Carcinoma
  • 17-409
  • Hypoxia negative
  • N1-2c oropharyngeal squamous cell carcinoma

Last Updated

January 3, 2020