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Adjuvant Stereotactic Pelvic Irradiation in Endometrial Cancer (ASPIRE)

K

King Saud University

Status and phase

Enrolling
Phase 2

Conditions

Endometrial Cancer

Treatments

Radiation: SABR

Study type

Interventional

Funder types

Other

Identifiers

NCT04235179
E-19-4466

Details and patient eligibility

About

Stereotactic Ablative Radiation (SABR/SBRT) will be prescribed to a dose of 30 Gy in 5 fractions, once weekly to the pelvis in post operative patients with endometrial cancer.

Enrollment

30 estimated patients

Sex

Female

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient with histologically confirmed endometrial adenocarcinoma
  • Patient is a candidate for adjuvant pelvic radiation (+/- vault brachytherapy), meeting one of the following conditions: High grade histology OR Outer-half myometrial invasion with any risk factors OR FIGO stage II - IIIC1.
  • 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.

Exclusion criteria

  • Patient has had prior pelvic radiotherapy.
  • Patient has Type II endometrial cancer histology (ie. Serous, clear cell or carcinosarcoma).
  • 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 CT contrast.
  • Patient has a hip prosthesis.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

SABR
Experimental group
Description:
Pelvic SABR for post-op endometrial cancer
Treatment:
Radiation: SABR

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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