Status:
ACTIVE_NOT_RECRUITING
Major De-escalation to 30 Gy for Select Human Papillomavirus Associated Oropharyngeal Carcinoma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
HPV-Associated Oropharyngeal Squamous Cell Carcinoma
Squamous Cell Carcinoma of the Neck
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ra...
Detailed Description
This non-randomized non-inferiority study will enroll HPV associated oropharyngeal carcinoma subjects. Subjects who also have no evidence of hypoxia will undergo a major de-escalated radiation therapy...
Eligibility Criteria
Inclusion
- \- Cohort A: 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
- Cohort B: Pathologically (histologically or cytologically) proven diagnosis of HPV associated squamous cell carcinoma of the oropharynx (tonsil, base of tongue, or oropharyngeal walls). Surgical removal of primary site is no longer required.
- 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 or Karnopsky Performance Status \>/= 50
- 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
- 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 in Cohort A. For Cohort B, this exclusion is removed.
- 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
Key Trial Info
Start Date :
October 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2025
Estimated Enrollment :
316 Patients enrolled
Trial Details
Trial ID
NCT03323463
Start Date
October 16 2017
End Date
October 31 2025
Last Update
January 28 2025
Active Locations (10)
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1
Hartford Healthcare (Data Collection)
Hartford, Connecticut, United States, 06102
2
Baptist Alliance MCI (Data Collection Only)
Miami, Florida, United States, 33143
3
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
4
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748