Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2026-01-01 @ 12:15 PM
Study NCT ID:
NCT02516969
Status:
COMPLETED
Last Update Posted:
2022-01-14
First Post:
2015-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Surgery With or Without Adjuvant Stereotactic Body Radiotherapy
Sponsor:
David A. Clump, MD, PhD
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: