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

NCT02655068 | Terminated Phase 3 DMC

• 1 other identifier: UPCI 12-057
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Carcinoma, Squamous Cell of Head and Neck

Keywords

Head and Neck Cancer; Definitive Therapy; Positron Emission Tomography - Computed Tomography (PET/CT); Computed Tomography (CT)

Outcome Measures

Primary Outcomes (1)

• Which type of surveillance following definitive therapy for HNC is superior, PET/CT or CT surveillance

  All patients will be followed for disease recurrence for at least 3 years after completing primary treatment. The date of documented disease recurrence will be noted and the elapsed time from completion of definitive therapy (surgery or last day of radiotherapy) to recurrence will serve as the co-primary endpoint. A comparison of time to recurrence between the two arms will be conducted only with patients having a documented recurrence. The outcome will be measured using tumor measurements at each follow up scan and documents using RECIST 1.1.

  3 years

Study Arms (2)

Computed Tomography (CT)

OTHER

Patients who undergo primary surgery will have their first study imaging surveillance at 3 months (+/- 30 days) post-surgery. CT surveillance will continue at 6,9,12,18,24 months. During years 3-5, or long term follow up, surveillance with history and physical examination will occur every 6 months (+/- 30 days). The last protocol-specified imaging will occur at 24 months; during long term follow-up imaging will be conducted per the judgment of the treating physicians, as indicated by the history and physical examination findings.

Other: Computed Tomography (CT)

PET/CT

OTHER

Patients who undergo primary radiotherapy will have their first study imaging surveillance at 6 months (+/- 30 days) post radiotherapy. The Positron Emission Tomography - Computed Tomography (PET/CT)surveillance will continue at 9,12,18,24 months. During years 3-5, or long term follow up, surveillance with history and physical examination will occur every 6 months (+/- 30 days). The last protocol-specified imaging will occur at 24 months; during long term follow-up imaging will be conducted per the judgment of the treating physicians, as indicated by the history and physical examination findings.

Other: PET/CT

Interventions

PET/CT OTHER

Patients who undergo primary radiotherapy will have their first study imaging surveillance at 6 months (+/- 30 days) post radiotherapy. The Positron Emission Tomography - Computed Tomography (PET/CT)surveillance will continue at 9,12,18,24 months. During years 3-5, or long term follow up, surveillance with history and physical examination will occur every 6 months (+/- 30 days). The last protocol-specified imaging will occur at 24 months; during long term follow-up imaging will be conducted per the judgment of the treating physicians, as indicated by the history and physical examination findings.

PET/CT

Computed Tomography (CT) OTHER

Patients who undergo primary surgery will have their first study imaging surveillance at 3 months (+/- 30 days) post-surgery. CT surveillance will continue at 6,9,12,18,24 months. During years 3-5, or long term follow up, surveillance with history and physical examination will occur every 6 months (+/- 30 days). The last protocol-specified imaging will occur at 24 months; during long term follow-up imaging will be conducted per the judgment of the treating physicians, as indicated by the history and physical examination findings

Also known as: CT

Computed Tomography (CT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site

Study Officials

• Jonas Johnson

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair of the Department of Otolaryngology

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: January 13, 2016
• Study Start: May 1, 2012
• Primary Completion: September 30, 2016
• Study Completion: September 30, 2016
• Last Updated: July 31, 2017

Record last verified: 2017-07

Locations

US (1)