Oropharyngeal Cancer
Conditions
Keywords
HPV, Radiotherapy Fractionation, Proliferation Saturation Index, Larynx, Pharynx
Brief 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.
Detailed description
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).
Interventions
RADIATIONRadiotherapy fractionation
Standard fractionation at 2Gy once daily or Hyperfractionation at 1.2 Gy twice daily (≥ 6 hours apart)
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
* Age \< 18 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Response at Week 4 of Treatment | At 4 weeks of treatment | Fractionation of radiation will be individualized based on patient Proliferation Saturation Index (PSI). Objective is to increase the rate of response of ≥ 32% at 4 weeks to 63% of patients, above the expected 49%. Result is reported as percentage of participants who met the criteria for ≥ 32% reduction in tumor volume by week 4. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Complete Response at 2-3 Months | 2-3 months post treatment | Rate of complete response by Computed Tomography (CT) at 2 months or Positron Emission Topography (PET)/CT at 3 months following completion of therapy |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJimmy Caudell, MD, PhD
H. Lee Moffitt Cancer Center and Research Institute
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Radiotherapy Fractionation Radiotherapy fractionation: Standard fractionation at 2Gy once daily or Hyperfractionation at 1.2 Gy twice daily (≥ 6 hours apart) | 55 |
| Total | 55 |
Baseline characteristics
| Characteristic | Radiotherapy Fractionation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 28 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 54 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 55 Participants |
| Region of Enrollment United States | 55 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 55 |
| other Total, other adverse events | 7 / 55 |
| serious Total, serious adverse events | 1 / 55 |
Outcome results
Primary
Percentage of Response at Week 4 of Treatment
Fractionation of radiation will be individualized based on patient Proliferation Saturation Index (PSI). Objective is to increase the rate of response of ≥ 32% at 4 weeks to 63% of patients, above the expected 49%. Result is reported as percentage of participants who met the criteria for ≥ 32% reduction in tumor volume by week 4.
Time frame: At 4 weeks of treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Radiotherapy Fractionation | Percentage of Response at Week 4 of Treatment | 61.2 percentage of participants |
Secondary
Rate of Complete Response at 2-3 Months
Rate of complete response by Computed Tomography (CT) at 2 months or Positron Emission Topography (PET)/CT at 3 months following completion of therapy
Time frame: 2-3 months post treatment
Population: Evaluable participants at 2-3 months post treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Radiotherapy Fractionation | Rate of Complete Response at 2-3 Months | Complete anatomic and/or metabolic response | 98.1 percentage of participants |
| Radiotherapy Fractionation | Rate of Complete Response at 2-3 Months | Partial anatomic and/or metabolic response | 2.1 percentage of participants |