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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03416153
Recruitment Status : Recruiting
First Posted : January 30, 2018
Last Update Posted : November 27, 2019
Sponsor:
Collaborators:
VA Ann Arbor Healthcare System
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Tracking Information
First Submitted Date  ICMJE January 23, 2018
First Posted Date  ICMJE January 30, 2018
Last Update Posted Date November 27, 2019
Actual Study Start Date  ICMJE May 21, 2018
Estimated Primary Completion Date November 21, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2018)
The percentage of patients with Local Regional Recurrence (LRR) of disease [ Time Frame: 1 Year ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2018)
  • The proportion of patients who progress in any location [ Time Frame: 2 Years ]
    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.
  • The proportion of patients alive [ Time Frame: 2 Years ]
  • Incidence of Toxicity [ Time Frame: 3, 6, 12 and 24 Months ]
    Toxicity outcomes will be estimated as proportions of patients with available toxicity data at 3, 6 12 and 24 months.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Individualized Adaptive De-escalated Radiotherapy for HPV-related Oropharynx Cancer
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Oropharynx Cancer
Intervention  ICMJE
  • Drug: Carboplatin
    AUC=1 weekly during radiation therapy. Carboplatin will be given once a week in combination with paclitaxel (standard treatment), concurrent with radiation therapy. Given IV.
  • Radiation: Radiation Therapy
    Patients will initially receive a single prescription of 70 Gy to PTV1 in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy). Dose will be reduced to 54Gy to high risk PTV and 43.2Gy to low risk PTV all in 27 fractions for patients who meet pPET-CT and iPET-CT parameters.
  • Drug: Paclitaxel
    30 mg/m2 weekly during radiation therapy. Paclitaxel will be given once a week in combination with carboplatin (standard treatment), concurrent with radiation therapy. Given IV.
Study Arms  ICMJE
  • Active Comparator: Standard Treatment
    Patients will receive a single prescription of 70 Gy in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy)
    Interventions:
    • Drug: Carboplatin
    • Radiation: Radiation Therapy
    • Drug: Paclitaxel
  • Experimental: De-escalation Treatment
    Patients will initially receive a single prescription of 70 Gy in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (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.
    Interventions:
    • Drug: Carboplatin
    • Radiation: Radiation Therapy
    • Drug: Paclitaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 23, 2018)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 21, 2022
Estimated Primary Completion Date November 21, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 4 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 4 weeks prior to registration;
  • Age ≥ 18;
  • Able to tolerate PET/CT imaging required to be performed
  • CBC/differential obtained within 4 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 4 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michelle Mierzwa, M.D. 734-936-7810 mmierzwa@umich.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03416153
Other Study ID Numbers  ICMJE UMCC 2017.113
HUM00136258 ( Other Identifier: University of Michigan )
U01CA183848 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of Michigan Rogel Cancer Center
Study Sponsor  ICMJE University of Michigan Rogel Cancer Center
Collaborators  ICMJE
  • VA Ann Arbor Healthcare System
  • National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Michelle Mierzwa, M.D. University of Michigan Rogel Cancer Center
PRS Account University of Michigan Rogel Cancer Center
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP