Spots Global Cancer Trial Database for Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus.

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Trial Identification

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 ID: NCT04458597

Conditions

Endometrioid Adenocarcinoma

Serous Carcinoma

Clear Cell Carcinoma

Carcinosarcoma

Dedifferentiated Carcinoma

Interventions

Image-guided adjuvant pelvic radiotherapy

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.

Detailed Description: