RECRUITING

Transoral Surgical Resection Followed by De-escalated Adjuvant IMRT in Resectable p16+ Locally Advanced Oropharynx Cancer

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Conditions

Oropharynx CancerPapillomavirus InfectionsCarcinoma, Squamous CellOropharyngeal NeoplasmsPapillomaNeoplasms, Glandular and EpithelialPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesDNA Virus InfectionsTumor Virus InfectionsAntineoplastic AgentsIntensity Modulated RadiotherapyCarboplatinCisplatinTransoral Surgery

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a trial studying patients with human papilloma virus (HPV) positive oropharyngeal cancer with tumors that can be removed via transoral surgery. Following surgery, patients will be classified as either low, intermediate, or high risk based on the characteristics of the tumors. Low risk patients (Arm S) will receive no further treatment after surgery. Intermediate risk patients (Arm RT) will be treated with Intensity Modulated Radiotherapy (IMRT) after surgery. High risk patients (Arm CRT) will receive a combination of IMRT and chemotherapy after surgery. Patients will be followed for up to five years after the completion of treatment.

Official Title

Phase II Trial of Transoral Surgical Resection Followed by De-escalated Adjuvant IMRT in Resectable p16+ Locally Advanced Oropharynx Cancer

Quick Facts

Study Start:2022-07-20
Study Completion:2030-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05388773

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ECOG performance status of 0 or 1 or Karnofsky score 80-100.
  2. * Newly diagnosed, histologically or cytologically confirmed SCC or undifferentiated carcinoma of the oropharynx and resectable oropharyngeal disease.
  3. * Patients must be deemed eligible for a TOS procedure with no evidence of distant metastasis as determined by imaging studies.
  4. * Biopsy-proven p16+ oropharynx cancer; the histologic evidence of invasive squamous cell carcinoma may have been obtained from the primary tumor or metastatic lymph node.
  5. * Carcinoma of the oropharynx associated with HPV as determined by p16 protein expression using immunohistochemistry (IHC) performed by a CLIA approved laboratory.
  6. * No prior radiation above the clavicles.
  7. * Patients with a history of a curatively treated malignancy must be disease-free for at least two years except for carcinoma in situ of cervix, melanoma in-situ (if fully resected), and/or non-melanomatous skin cancer.
  8. * Patients with congestive heart failure \> NYHA Class II, CVA/TIA, unstable angina, or myocardial infarction within the last 6 months prior to registration must be evaluated by a cardiologist and/or neurologist.
  9. * Acceptable renal and hepatic function within 4 weeks prior to registration as predefined.
  1. * No evidence of extensive or "matted/fixed" pathologic adenopathy on preoperative imaging.
  2. * Women must not be pregnant or breast-feeding due to the teratogenicity of chemotherapy.
  3. * No intercurrent illness likely to interfere with protocol therapy or prevent surgical resection.
  4. * No uncontrolled diabetes, infection despite antibiotics, or hypertension within 30 days prior to registration.

Contacts and Locations

Study Contact

Brieana Marino, MS
CONTACT
412-647-8258
rowlesbm@upmc.edu
Samantha Demko, RN, BSN
CONTACT
412-623-1400
albesl@upmc.edu

Principal Investigator

Heath Skinner, MD, PhD
PRINCIPAL_INVESTIGATOR
UPMC Hillman Cancer Center

Study Locations (Sites)

UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
United States

Collaborators and Investigators

Sponsor: Heath Skinner

  • Heath Skinner, MD, PhD, PRINCIPAL_INVESTIGATOR, UPMC Hillman Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-20
Study Completion Date2030-06

Study Record Updates

Study Start Date2022-07-20
Study Completion Date2030-06

Terms related to this study

Keywords Provided by Researchers

  • Papillomavirus Infections
  • Carcinoma, Squamous Cell
  • Oropharyngeal Neoplasms
  • Papilloma
  • Neoplasms, Glandular and Epithelial
  • Pharyngeal Neoplasms
  • Otorhinolaryngologic Neoplasms
  • Head and Neck Neoplasms
  • Pharyngeal Diseases
  • Stomatognathic Diseases
  • Otorhinolaryngologic Diseases
  • DNA Virus Infections
  • Tumor Virus Infections
  • Antineoplastic Agents
  • Intensity Modulated Radiotherapy
  • Carboplatin
  • Cisplatin
  • Transoral Surgery

Additional Relevant MeSH Terms

  • Oropharynx Cancer