Back to resultsStereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus.
Primary Purpose
Endometrioid Adenocarcinoma, Serous Carcinoma, Clear Cell Carcinoma
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Image-guided adjuvant pelvic radiotherapy
Sponsored by
About this trial
This is an interventional basic science trial for Endometrioid Adenocarcinoma
Eligibility Criteria
Inclusion Criteria:
- Patients, who have undergone hysterectomy for curative intent, with histologically confirmed endometrioid adenocarcinoma, serous or clear cell carcinoma, or carcinosarcoma or dedifferentiated carcinoma
Patient is a candidate for adjuvant pelvic radiation (+/- vault brachytherapy), meeting one of the following conditions:
- High grade histology OR
- Outer-half myometrial invasion and FIGO grade 1-2 OR
- FIGO stage II - IIIC1 (all gross nodal disease must be resected)
- Patient is willing and able to give informed consent to participate in this clinical trial.
- Age ≥18 years.
- Patients who are to receive adjuvant systemic therapy in addition to pelvic radiotherapy will be eligible provided that there is at minimum a 3-week interval between any radiation treatment and chemotherapy treatments. Adjuvant systemic therapy may be given before or after radiation treatment.
- Patient must be willing and able to complete the QLQ-C30 questionnaire with EN-24 companion as described in the study protocol.
- Primary language of the patient must be English or, if a patient's primary language is not English, they are still able to participate provided the QLQ-C30 and EN-24 is available in their primary language.
Exclusion Criteria:
- Patient has had prior pelvic radiotherapy.
- Patient has received neo-adjuvant systemic therapy
- Patient has a contraindication to pelvic radiotherapy, such as but not limited to a connective tissue disease or inflammatory bowel disease.
- Patient has a contraindication to iodinated CT contrast.
- Patient has a hip prosthesis.
Sites / Locations
- London Regional Cancer Program
Outcomes
Primary Outcome Measures
Assess the acute urinary and bowel toxicities
Acute urinary and bowel toxicities associated with adjuvant SBRT treatment in the setting of high-risk endometrial cancer will be assessed using the Common Terminology Criteria for Adverse Events.
Secondary Outcome Measures
Full Information
NCT ID
NCT04458597
First Posted
June 23, 2020
Last Updated
March 7, 2023
Sponsor
Lawson Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04458597
Brief Title
Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus.
Official Title
Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus: A Phase 1 Pilot Study (SPARTACUS)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 26, 2020 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Advanced technology has enabled radiation oncologists to more accurately and precisely target radiation to areas at risk while maximally sparing healthy tissue. Furthermore, there is growing evidence demonstrating both safety and efficacy for SBRT. We propose that these advantages are translatable to the adjuvant treatment of endometrial cancer. We submit that a prescription dose of 30 Gy in 5 fractions, which equates to a 2 Gy equivalent dose (i.e an EQD2) (α/β = 10 Gy) of 48 Gy, compares favorably to the EQD2 delivered standardly for adjuvant treatment (44.25 Gy via 45Gy/25Fx; 50 Gy at vaginal surface for vault brachytherapy) and therefore should be effective and safe dose in the adjuvant setting. Through precision delivery and careful dosimetry the treatment should be safe and well tolerated with minimal impact on patient quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrioid Adenocarcinoma, Serous Carcinoma, Clear Cell Carcinoma, Carcinosarcoma, Dedifferentiated Carcinoma
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Radiation
Intervention Name(s)
Image-guided adjuvant pelvic radiotherapy
Intervention Description
Image-guided adjuvant pelvic radiotherapy delivered at an SBRT prescription dose of 30 Gy in 5 fractions if feasible, well-tolerated and effective for the adjuvant treatment of high-risk endometrial cancer.
Primary Outcome Measure Information:
Title
Assess the acute urinary and bowel toxicities
Description
Acute urinary and bowel toxicities associated with adjuvant SBRT treatment in the setting of high-risk endometrial cancer will be assessed using the Common Terminology Criteria for Adverse Events.
Time Frame
Baseline to 2 years post-treatment.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients, who have undergone hysterectomy for curative intent, with histologically confirmed endometrioid adenocarcinoma, serous or clear cell carcinoma, or carcinosarcoma or dedifferentiated carcinoma
Patient is a candidate for adjuvant pelvic radiation (+/- vault brachytherapy), meeting one of the following conditions:
High grade histology OR
Outer-half myometrial invasion and FIGO grade 1-2 OR
FIGO stage II - IIIC1 (all gross nodal disease must be resected)
Patient is willing and able to give informed consent to participate in this clinical trial.
Age ≥18 years.
Patients who are to receive adjuvant systemic therapy in addition to pelvic radiotherapy will be eligible provided that there is at minimum a 3-week interval between any radiation treatment and chemotherapy treatments. Adjuvant systemic therapy may be given before or after radiation treatment.
Patient must be willing and able to complete the QLQ-C30 questionnaire with EN-24 companion as described in the study protocol.
Primary language of the patient must be English or, if a patient's primary language is not English, they are still able to participate provided the QLQ-C30 and EN-24 is available in their primary language.
Exclusion Criteria:
Patient has had prior pelvic radiotherapy.
Patient has received neo-adjuvant systemic therapy
Patient has a contraindication to pelvic radiotherapy, such as but not limited to a connective tissue disease or inflammatory bowel disease.
Patient has a contraindication to iodinated CT contrast.
Patient has a hip prosthesis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David D'Souza, M.D.
Organizational Affiliation
London Regional Cancer Program
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Regional Cancer Program
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus.
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