Clinical Trials /

Individualized Adaptive De-escalated Radiotherapy for HPV-related Oropharynx Cancer

NCT03416153

Description:

This prospective study aims to utilize pre- and mid-treatment PET-CT to guide de-escalation of radiation therapy in HPV-related squamous cell carcinoma of the oropharynx.

Related Conditions:
  • Oropharyngeal Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Individualized Adaptive De-escalated Radiotherapy for HPV-related Oropharynx Cancer
  • Official Title: A Multi-Center Phase II Trial of Individualized Adaptive De-escalated Radiotherapy Using Pre and Mid-Treatment FDG-PET/CT for HPV-related Oropharynx Cancer

Clinical Trial IDs

  • ORG STUDY ID: UMCC 2017.113
  • SECONDARY ID: HUM00136258
  • NCT ID: NCT03416153

Conditions

  • Oropharynx Cancer

Interventions

DrugSynonymsArms
CetuximabStandard Treatment

Purpose

This prospective study aims to utilize pre- and mid-treatment PET-CT to guide de-escalation of radiation therapy in HPV-related squamous cell carcinoma of the oropharynx.

Trial Arms

NameTypeDescriptionInterventions
Standard TreatmentActive ComparatorPatients will receive a single prescription of 70 Gy in 35 fractions with RT given once daily, 5 days a week along with weekly cetuximab (standard therapy)
  • Cetuximab
De-escalation TreatmentExperimentalPatients will initially receive a single prescription of 70 Gy in 35 fractions with RT given once daily, 5 days a week along with weekly cetuximab (standard therapy). If certain parameters are met radiation therapy will be reduced to 54Gy to high risk Planned Target Volume (PTV) and 43.2Gy to low risk PTV all in 27 fractions.
  • Cetuximab

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must have FDG-avid and histologically or cytologically proven squamous cell
             carcinoma of the oropharynx (tonsil, base of tongue, oropharyngeal wall, soft palate)
             that is p16 positive by immunohistochemistry or HPV positive by in situ hybridization.

          -  AJCC eighth edition staging stage 1 and stage 2

          -  Appropriate stage for protocol entry, including no distant metastases, based upon the
             following minimum diagnostic workup:

          -  History/physical examination, including documentation of weight within 2 weeks prior
             to registration;

          -  FDG-PET/CT scan for staging and RT plan within 4 weeks prior to registration;

          -  Zubrod Performance Status (A quantification of the functional status of cancer
             patients that runs from 0 to 5, with 0 denoting perfect health and 5 death) 0-1 within
             2 weeks prior to registration;

          -  Age ≥ 18;

          -  Able to tolerate PET/CT imaging required to be performed

          -  CBC/differential obtained within 2 weeks prior to registration on study, with adequate
             bone marrow function;

          -  Serum creatinine within normal institutional limits or a creatinine clearance ≥ 45
             ml/min within 2 weeks prior to registration;

          -  Women of childbearing potential and male participants must agree to use a medically
             effective means of birth control throughout their participation in the treatment phase
             of the study.

          -  The patient must provide study-specific informed consent prior to study entry.

        Exclusion Criteria:

          -  cT4, cN3 or cM1 disease

          -  "Matted nodes" as determined by review with Neuroradiology

          -  Gross total excision of both primary and nodal disease with curative intent; this
             includes tonsillectomy, local excision of primary site, and nodal excision that
             removes all clinically and radiographically evident disease. In other words, to
             participate in this protocol, the patient must have clinically or radiographically
             evident gross disease for which disease response can be assessed.

          -  Carcinoma of the neck of unknown primary site origin (even if p16 positive);

          -  Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free
             for a minimum of 3 years

          -  Any prior therapy for the study cancer; note that prior chemotherapy for a different
             cancer is allowable if > 3 years prior to study;

          -  Prior radiotherapy to the region of the study cancer that would result in overlap of
             radiation therapy fields;

          -  Severe, active co-morbidity;

          -  Pregnancy or women of childbearing potential and men who are sexually active and not
             willing/able to use medically acceptable forms of contraception;

          -  Poorly controlled diabetes
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:The percentage of patients with Local Regional Recurrence (LRR) of disease
Time Frame:1 Year
Safety Issue:
Description:RECIST (Response Evaluation Criteria In Solid Tumors) will be used to evaluate response and recurrence. All patients will be analyzed together as the goal of the study is to estimate risk of LRR in this patient population treated with this particular strategy in which some patients continue to receive standard therapy while others are de-escalated. Results will also be estimated and reported separately for patients receiving standard or de-escalated therapy.

Secondary Outcome Measures

Measure:The proportion of patients who progress in any location
Time Frame:2 Years
Safety Issue:
Description:RECIST (Response Evaluation Criteria In Solid Tumors) will be used to evaluate response. Progression will be defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study or the appearance of one or more new lesions.
Measure:The proportion of patients alive
Time Frame:2 Years
Safety Issue:
Description:
Measure:Incidence of Toxicity
Time Frame:3, 6, 12 and 24 Months
Safety Issue:
Description:Toxicity outcomes will be estimated as proportions of patients with available toxicity data at 3, 6 12 and 24 months.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:University of Michigan Cancer Center

Last Updated

March 14, 2018