Phase III Trial of PET/CT vs. CTSurveilance for Head and Neck Cancer

Stopped early · Phase 3

Conditions studied: Carcinoma, Squamous Cell of Head and Neck

In brief

The null hypothesis is that patients screened by PET/CT will not have detection of disease recurrence any earlier than those screened by CT alone. The alternative hypothesis is that PET/CT surveillance will lead to detection of disease recurrence 3 months earlier than CT surveillance. Furthermore, to reject the null hypothesis, earlier detection must be associated with a cause-specific survival improvement of 10%. Primary endpoints will include time from the completion of definitive therapy to diagnosis of recurrent disease, and absolute survival within 3 years after completion of initial therapy. Duration of survival between diagnosis of recurrence and subsequent death will not be a primary endpoint because the investigators expect that PET/CT will offer an opportunity for earlier recognition of recurrence and be subject to lead-time bias. Duration of survival will be measured from completion of primary treatment until death. Note: the presence of residual disease at surgical consolidation does not constitute a recurrence event.

Key facts

Study ID

NCT02655068

Run by

University of Pittsburgh

People needed

38

Starts

2012-05-01

Expected to finish

2016-09-30

Last updated by the study team

2017-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histopathologically confirmed carcinoma arising in the head and neck. Histologies may include squamous cell carcinoma, poorly differentiated carcinoma, carcinoma NOS, basaloid carcinoma, or salivary gland carcinoma (including mucoepidermoid carcinoma, salivary duct carcinoma, adenocarcinoma, and adenoid cystic carcinoma).
• Primary site of origin must be one of the following: a) the oral cavity, pharynx, or larynx; b) major or minor salivary gland; c) skin; d) unknown primary site is acceptable in patients with squamous cell carcinoma metastatic to cervical lymph nodes.
• Stage III-IVb based upon AJCC 7th edition staging criteria. 4. Serum creatinine ≤ 1.5 mg/dL (most recent within the last three months) 5. The treating multidisciplinary team agrees that the patient has no evidence of disease (NED) after definitive therapy.
• Patients who have undergone primary surgery with R0 or R1 resection are eligible to enter the protocol for 6 weeks after the date of definitive surgery. Note: Patients treated with primary surgery will undergo first study surveillance 3 months (+/- 30 days) after the date of definitive surgery.
• Patients who have undergone primary radiotherapy (including chemoradiotherapy) must have completed first response assessment 6-14 weeks after completion of radiotherapy. To be eligible, patients must be determined by the multidisciplinary team to without clear evidence of residual disease, without need of surgical consolidation, and appropriate to enter surveillance. Such patients are eligible to enter the surveillance protocol for 6 weeks after the date of first response assessment. Patients requiring surgical consolidation of the primary site and/or neck are eligible following the consolidative surgery, provided benign findings or negative margins were attained. Such patients are eligible to enter the surveillance protocol for 6 weeks after the date of consolidative surgery.
• Note: Patients treated with primary radiotherapy will undergo first study surveillance 6 months (+/-30 days) after completing radiotherapy.
• In the case of oropharyngeal primary squamous cell carcinomas, HPV status must be classified per standard of care. HPV(+) disease will be those cases which demonstrate diffuse nuclear and cytoplasmic staining in ≥ 70% tumor cells by p16 immunohistochemistry (IHC).
• Age ≥ 18 years 8. Able to provide written, informed consent 9. ECOG Performance Status 0-2

You may not qualify if…

• Severe allergy to iodinated contrast, despite appropriate premedications 2. Presence of gross residual disease after surgical resection 3. Serum creatinine > 1.5 mg/dL 4. Who Type II or III non-keratinizing squamous cell carcinoma of the nasopharynx

Where it is running

• University of Pittsburgh Cancer Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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