Clinical trial NCT02516969: Surgery With or Without Adjuvant Stereotactic Body Radiotherapy
Official title: A Prospective, Randomized Phase II Study of Surgery With or Without Adjuvant Stereotactic Body Radiotherapy (SBRT) in Patients With Previously-Irradiated Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Keywords: Stereotactic Body Radiotherapy (SBRT)
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2015-08-06
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Comparison of patients with operable, recurrent previously-irradiated squamous cell head-and-neck cancers with or without adjuvant SBRT.

Detailed description: This study aims to determine prognostic factors that may predict the likelihood of local failure, regional failure, to guide future management, to compare the impact of adjuvant SBRT versus a wait-and-see approach on patient reported quality of life (PR-QoL), and to compare surgical versus SBRT-induced immunological serum markers in relation to local control. Recruitment includes patients with recurrent or second-primary head-and-neck squamous cell carcinomas within a previously-irradiated field with high-risk features compromised/positive surgical margins or extra-nodal extension) following macroscopic complete (R0/R1) salvage surgery.

Participants receive Stereotactic Body Radiotherapy at the following levels:

Treatment Volumes \<25cc will receive 40Gy (5 fractions of 8Gy per fraction) or treatment Volumes ≥25cc will receive 44-50Gy (5 fractions of 8.8-10Gy per fraction). Ideally all tumors volumes ≥25cc will receive 50Gy over 5 fractions, however at the discretion of the treating radiation oncologist based on tumor bed volume, prior radiation dose, and proximity to critical organs the dose can be reduced to 44Gy over 5 fractions as outlined in prior SBRT protocols. Evaluations to compare the efficacy of adjuvant SBRT versus wait-and-see, include Local Control, Regional and distant control, Progression-free survival, Overall survival and Patient-Reported Quality-of-Life (PR-QoL).

Evaluations conducted to assess the safety of adjuvant SBRT following salvage surgery include recording of all toxicity data per National Cancer Institute Common Toxicity Criteria Events Scale version 4.0 and prospectively administering the previously-validated University of Washington Quality-of-Life-Revised (UW-QoL-R) questionnaire measuring patient-reported quality-of-life (PR-QoL).

Eligibility criteria: Inclusion Criteria:

* Pathologically proven recurrent or second-primary head-and-neck cancer receiving prior radiotherapy with or without chemotherapy.
* Prior radiotherapy to a dose of ≥50Gy
* No evidence of distant metastases
* Macroscopic complete salvage surgery with curative intent (surgery was not performed only for biopsy or palliation). Final pathology and imaging must indicate a R0 or R1 resection (no gross disease remaining).
* High-risk pathologic features must be present: compromised/positive surgical margins (≤ 2mm) or extra-nodal extension (patient with other high-risk features gross perinueral invasion, bone invasion, angiolyphatic invasion, or a constellation of these factors may be eligible based on case-by-case basis at discretion of principal investigator).
* Karnofsky Performance Status ≥60 (ECOG 0-2)
* Any number or type of prior chemotherapy is allowed (patient may receive concurrent or adjuvant systemic therapy such as cetuximab at the discretion of the treating oncologic team)

Exclusion Criteria:

* Evidence of distant metastases on any staging or imaging modality
* Women who are breast feeding, or have a positive pregnancy test (reproductive age should use effective birth control during study if randomized to SBRT treatment arm)
* Any patient with gross residual disease following salvage surgery
* Any co-morbidity or condition of sufficient severity to limit full compliance with the protocol per assessment by the principal investigator.

Primary outcomes:
measure: 1-year Local Control
timeFrame: Up to 1 year
Secondary outcomes:
measure: Number of Participants With Acute Toxicities of Adjuvant SBRT
timeFrame: Up to 2 years
measure: Number of Participants With Late Toxicities of Adjuvant SBRT
timeFrame: Up to 2 years
measure: Progression-free Survival (PFS) Locoregional
timeFrame: Up to 2 years
measure: Progression-free Survival (DPFS) Distant
timeFrame: Up to 2 years
measure: Overall Progression Free Survival (PFS)
timeFrame: Up to 2 years
measure: Overall Survival (OS)
timeFrame: Up to 5 years
measure: Quality of Life (UW-QoL-R)
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Shadyside Radiation Oncology
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: David A Clump, MD
role: PRINCIPAL_INVESTIGATOR
References: