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.
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
- SECONDARY ID:
U01CA183848
- NCT ID:
NCT03416153
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Carboplatin | | De-escalation Treatment |
Paclitaxel | | De-escalation 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
Name | Type | Description | Interventions |
---|
Standard Treatment | Active Comparator | 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) | |
De-escalation Treatment | Experimental | 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. | |
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 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
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: | Recruiting |
Lead Sponsor: | University of Michigan Rogel Cancer Center |
Last Updated
January 15, 2021