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Clinical Trial 19579

Cancer Type: Head & Neck
Interventions:

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Jimmy Caudell

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

Use of a Proliferation Saturation Index to Determine Personalized Radiotherapy Fractionation for Patients with HPV+ Oropharyngeal Cancers.

Summary

This study is to determine whether a mathematical model can be used to choose a radiation delivery method to improve the rate of a rapid response. Investigators hypothesize that using individual patient proliferation saturation index (PSI) to select radiotherapy fractionation (conventional fractionation or hyperfractionation) may improve the likelihood of a rapid response (defined as ≥ 32% reduction in volume at 4 weeks).

Objective

Primary Objective:We hypothesize that by using individual patient proliferation saturation index (PSI) to select radiotherapy fractionation (conventional fractionation or hyperfractionation) to improve the likelihood of a rapid response (defined as ¡Ý 32% reduction in volume at 4 weeks). Secondary Objectives:1)Rate of complete response by CT at 2 months or PET/CT at 3 months following completion of therapy. 2)Correlate response and outcome to pre-treatment and during treatment radiomics features on PET/CT/MRI. 3)Correlate response and outcome to mathematical models of tumor growth and death dynamics pre-treatment and during treatment. Primary Endpoint: For patients with squamous cancer of the head and neck, fractionation of radiation will be individualized based on their PSI. Response will be measured after 20 days of RT as assessed by CT or MRI, as described in section 10.0. Primary objective is to increase the rate of response of ¡Ý 32% at 20 days to 63% of patients, above the expected 49%.

Inclusion Criteria

> Stated willingness to comply with all study procedures and availability for the duration of the study

  • Male or female, aged ≥ 18 years
  • Pathologically (histologically or cytologically) proven diagnosis of p16+ or HPV+ squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx; cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx. Clinical evidence should be documented, and may consist of pathology, palpation, imaging, or endoscopic evaluation, and should be sufficient to estimate the size of the primary (for T stage).
  • American Joint Committee on Cancer (AJCC) 8th edition staging T1-3 N0-1 MO
  • Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations.
  • CT or MRI performed at least 1 week apart. This can consist of diagnostic imaging and radiation therapy planning imaging.
  • No evidence of distant metastases
  • Eastern Cooperative Oncology Group Performance Status 0 to 3

  • Exclusion Criteria

    > Under 18 years of age

  • Positive urine pregnancy test
  • Evidence of distant metastases
  • Gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that remove all clinically and radiographically evident disease
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Patients with a medical condition or social situation that at the discretion of the PI would preclude them from completion of the trial