Interim Digital PET/CT in Predicting Outcomes for Participants With Locally Advanced Oropharyngea… (NCT03611205) | Clinical Trial Compass
WithdrawnNot Applicable
Interim Digital PET/CT in Predicting Outcomes for Participants With Locally Advanced Oropharyngeal Cancer Undergoing Chemoradiation Therapy
Stopped: PI decision
0Started 2019-07-01
Plain-language summary
This pilot trial studies how well interim digital positron emission tomography (PET)/computed tomography (CT) works in predicting outcomes in participants with oropharyngeal cancer that has spread from its original site of growth to nearby tissues or lymph nodes who are undergoing chemoradiation therapy. Diagnostic procedures, such as PET/CT may help measure a participant's response to treatment.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patient who will undergo definitive radiation with concurrent chemotherapy with weekly (preferred) or high dose cisplatin for histologically confirmed locally advanced squamous cell carcinoma of the oropharyngeal carcinoma
* Patient must have clinically or radiographically evident measurable disease at the primary site and at nodal station(s). Tonsillectomy or local excision of the primary or nodal disease is not permitted
* P16 and/or human papillomavirus (HPV) status obtained on biopsy specimen
* Low risk classification:
* HPV positive, T1-3, N1-2b, M0 with =\< 10 pack years smoking history
* Note: Twenty cigarettes is considered equivalent to one pack.
* Number of pack years = (number \[No.\] of cigarettes per day x number of years of smoking)/20 OR
* Intermediate risk classification:
* HPV positive, T4, N3, M0 and/or HPV positive with \> 10 pack year smoking history
* HPV negative, T1-3, N1-2b, M0, with =\< 10 pack years smoking history OR
* High risk classification: HPV negative, T4, N3, M0 and/or HPV negative with \> 10 pack year smoking history
* Patients with no contraindications to PET imaging or cisplatin as stated in the section Exclusion Criteria
* No prior history of radiation therapy
* Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Patients with remaining teeth will have undergo a dental evaluation prior to enrollment
* Ability to provide informed consent obtained prior to partic…
What they're measuring
1
Quantitative assessments of digital positron emission tomography (dPET) characteristics generated at early time points during treatment
Timeframe: Up to 2 years
Trial details
NCT IDNCT03611205
SponsorOhio State University Comprehensive Cancer Center