Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.

Condition or disease Intervention/treatment Phase
Oropharynx Cancer Drug: Carboplatin Radiation: Radiation Therapy Drug: Paclitaxel Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 21, 2018
Estimated Primary Completion Date : November 21, 2021
Estimated Study Completion Date : November 21, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)
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.

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.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. The proportion of patients alive [ Time Frame: 2 Years ]
  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03416153


Contacts
Layout table for location contacts
Contact: Michelle Mierzwa, M.D. 734-936-7810 mmierzwa@umich.edu

Locations
Layout table for location information
United States, Michigan
University of Michigan Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Michelle Mierzwa, M.D.    734-936-7810    mmierzwa@umich.edu   
Principal Investigator: Michelle Mierzwa, M.D.         
VA Ann Arbor Healthcare System Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Michelle Mierzwa, M.D.    734-936-7810    mmierzwa@umich.edu   
Principal Investigator: Christina Chapman, MD         
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
VA Ann Arbor Healthcare System
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Michelle Mierzwa, M.D. University of Michigan Rogel Cancer Center
Layout table for additonal information
Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT03416153    
Other Study ID Numbers: UMCC 2017.113
HUM00136258 ( Other Identifier: University of Michigan )
U01CA183848 ( U.S. NIH Grant/Contract )
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Oropharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action