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a SIngle Center Study of Post-operative STEReotactic RAdiotherapY for Endometrial Cancer

ConditionEndometrial Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorARNAS Civico Di Cristina Benfratelli Hospital

About this trial

The primary endpoint of the present prospective study is to assess the outcomes in terms of acute toxicity of post-operative stereotactic radiotherapy for endometrial cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-80 years

ECOG PS ≤ 2 or KPS ≥ 70%

Patients diagnosed with endometrial cancer (endometrioid, serous cell, clear cell, carcinosarcoma) FIGO stage IB-IIIC1 candidate to post-operative external beam radiotherapy, based on molecular and histological findings

Indications for chemotherapy and/or brachytherapy are not

Disqualifiers

Written Informed Consent

Prior pelvic radiotherapy

Para-aortic lymph nodes involvement

ECOG PS ≥ 3

Trial design

Design model

Single group

Treatments tested in this trial

  • Stereotactic Post-operative Radiotherapy for Endometrial Cancer

    Radiation

    Patients candidate to receive adjuvant radiotherapy will be assigned to a shorter schedule of 30 Gy in 5 sessions.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Experimental armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Acute G3 or higher Gastrointestinal and Genitourinary Toxicity

The number of any G3 or higher adverse event occurring within 90 days from the end of radiotherapy and assessed according to the CTCAE v5.0 criteria

Time frame
From the end of treatment to a time interval of 12 weeks

Secondary outcomes

1

Late Gastrointestinal and Genitourinary Toxicity

The number of any G3 or higher adverse event occurring after 90 days from the end of radiotherapy and assessed according to the CTCAE v5.0 criteria

Time frame
From enrollment to a follow-up time of 5 years
2

Distant Progression Free Survival

The rate of distant failure of the disease in all the participants enrolled for adjuvant SBRT

Time frame
From enrollment to a follow-up time of 5 years
3

Local Control

The rate of local failure of the disease in all the participants enrolled for adjuvant SBRT

Time frame
From enrollment to a follow-up time of 5 years
4

Overall Survival

The rate of death events in the cohort of patients enrolled

Time frame
From enrollment to a follow-up time of 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ARNAS Civico Di Cristina Benfratelli Hospital

Lead sponsor

Accuray Incorporated

Collaborator

Source ClinicalTrials.gov
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