Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus.
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ClinicalTrials.gov Identifier: NCT04458597 |
Recruitment Status :
Recruiting
First Posted : July 7, 2020
Last Update Posted : September 4, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Endometrioid Adenocarcinoma Serous Carcinoma Clear Cell Carcinoma Carcinosarcoma Dedifferentiated Carcinoma | Radiation: Image-guided adjuvant pelvic radiotherapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus: A Phase 1 Pilot Study (SPARTACUS) |
Actual Study Start Date : | August 26, 2020 |
Estimated Primary Completion Date : | September 1, 2022 |
Estimated Study Completion Date : | September 1, 2022 |

- Radiation: Image-guided adjuvant pelvic radiotherapy
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.
- Assess the acute urinary and bowel toxicities [ Time Frame: Baseline to 2 years post-treatment. ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04458597
Contact: Susan Archer | 519-685-8618 | susan.archer@lhsc.on.ca |
Canada, Ontario | |
London Regional Cancer Program | Recruiting |
London, Ontario, Canada, N6A 5W9 | |
Contact: David D'Souza, MD 519-685-8500 David.DSouza@lhsc.on.ca |
Principal Investigator: | David D'Souza, M.D. | London Regional Cancer Program |
Responsible Party: | Lawson Health Research Institute |
ClinicalTrials.gov Identifier: | NCT04458597 |
Other Study ID Numbers: |
SPARTACUS |
First Posted: | July 7, 2020 Key Record Dates |
Last Update Posted: | September 4, 2020 |
Last Verified: | September 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Carcinoma Carcinoma, Endometrioid Carcinosarcoma Cystadenocarcinoma, Serous Adenomyoepithelioma Adenocarcinoma, Clear Cell Uterine Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Endometrial Neoplasms Genital Neoplasms, Female |
Urogenital Neoplasms Neoplasms by Site Ovarian Neoplasms Ovarian Diseases Adnexal Diseases Gonadal Disorders Endocrine System Diseases Neoplasms, Complex and Mixed Sarcoma Neoplasms, Connective and Soft Tissue Cystadenocarcinoma Neoplasms, Cystic, Mucinous, and Serous Uterine Diseases |