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Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04458597
Recruitment Status : Not yet recruiting
First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Lawson Health Research Institute

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.

Condition or disease Intervention/treatment Phase
Endometrioid Adenocarcinoma Serous Carcinoma Clear Cell Carcinoma Carcinosarcoma Dedifferentiated Carcinoma Radiation: Image-guided adjuvant pelvic radiotherapy Not Applicable

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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)
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : September 1, 2022



Intervention Details:
  • 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.


Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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

Information from the National Library of Medicine

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


Contacts
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Contact: Susan Archer 519-685-8618 susan.archer@lhsc.on.ca

Sponsors and Collaborators
Lawson Health Research Institute
Investigators
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Principal Investigator: David D'Souza, M.D. London Regional Cancer Program
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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: July 7, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Neoplasms, Complex and Mixed
Sarcoma
Neoplasms, Connective and Soft Tissue
Cystadenocarcinoma
Neoplasms, Cystic, Mucinous, and Serous
Uterine Diseases