Surgery With or Without Adjuvant Stereotactic Body Radiotherapy

NCT02516969 | Completed Results DMC FDA Device

• 1 other identifier: 14-151
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Head and Neck Cancer

Keywords

Stereotactic Body Radiotherapy (SBRT)

Outcome Measures

Primary Outcomes (1)

• 1-year Local Control

  Local progression-free-survival (LPFS) is the number of months from the initiation of study treatment until (local) progression of disease or death from any cause. Progression is defined as the appearance of a new metastatic lesion or objective tumor progression. Clinically detected lesions will only be considered measurable when superficial (vis-à-vis skin modules and palpable lymph nodes). The lesion must be accurately measured in at least one dimension ≥ 10mm. Methods for measuring disease status include CT, PET/CT or MRI.

  Up to 1 year

Secondary Outcomes (7)

• Number of Participants With Acute Toxicities of Adjuvant SBRT

  Up to 2 years

• Number of Participants With Late Toxicities of Adjuvant SBRT

  Up to 2 years

• Progression-free Survival (PFS) Locoregional

  Up to 2 years

• Progression-free Survival (DPFS) Distant

  Up to 2 years

• Overall Progression Free Survival (PFS)

  Up to 2 years

Study Arms (1)

Stereotactic Body Radiotherapy

EXPERIMENTAL

Subjects will 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.

Radiation: Stereotactic Body Radiotherapy

Interventions

Stereotactic Body Radiotherapy RADIATION

Radiation

Also known as: SBRT

Stereotactic Body Radiotherapy

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• David A. Clump, MD, PhD: lead

Study Sites (1)

UPMC Shadyside Radiation Oncology

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Barbara M. Stadterman, MPH, MSCR, CCRP
• Organization: UPMC Hillman Cancer Center

stadtermanbm@upmc.edu

412-647-5554

Study Officials

• David A Clump, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 30, 2015
• First Posted: August 6, 2015
• Study Start: August 1, 2015
• Primary Completion: May 30, 2019
• Study Completion: August 6, 2021
• Last Updated: January 14, 2022
• Results First Posted: January 14, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)