Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus II

Endometrial Cancer Clinical Trial

— SPARTACUSII  

Official title:

Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus II: A Phase II Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04890912
• Other study ID #: SPARTACUS II
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: October 2021
• Source: Sunnybrook Health Sciences Centre
• Contact: Anika Mohan
• Phone: 416-480-5000
• Email: anika.mohan[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Adjuvant radiotherapy (RT) plays an important role in reducing the risks of local recurrence after surgery in uterine cancers. Standard adjuvant pelvic radiation treatment targets the pelvic lymph nodes, the post-operative bed, and the upper vagina and is typically treated with intensity modulated radiation therapy (IMRT) which has been shown to improve patient reported gastrointestinal (GI) and genitourinary (GU) toxicities. Although pelvic radiation has been shown to be effective at decreasing locoregional recurrences, patient quality of life and experience can be significantly impacted as pelvic RT comprises of daily radiation for 25 daily treatments, which can be a substantial burden on patients with this disease. Hypofractionated radiotherapy to a dose of 30 Gy in 5 fractions (6 Gy given every other day) for adjuvant radiation treatment in uterine cancer is hypothesized to result in similar rates of acute gastrointestinal toxicities as conventional fractionated radiation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient with histologically confirmed endometrial adenocarcinoma, serous or clear cell carcinoma.

2. Patient is a candidate for adjuvant pelvic radiation for uterine cancer (+/- vault brachytherapy), meeting one of the following conditions:

High grade histology (including serous and clear cell) OR Outer-half myometrial invasion and International Federation of Gynecology and Obstetrics (FIGO) grade 1-2 OR FIGO stage II - III.

3. Patients who are to receive adjuvant systemic therapy sequentially in addition to pelvic radiotherapy will be eligible.

4. Age =18 years.

5. Patient is willing and able to give informed consent to participate in this clinical trial.

Exclusion Criteria:

1. Patient has had prior pelvic radiotherapy.

2. Patient has a contraindication to pelvic radiotherapy, such as but not limited to a connective tissue disease or inflammatory bowel disease.

3. Patient planned for concurrent chemoradiation therapy.

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms
• Uterine Neoplasms

Intervention

Radiation:
• Conventional Fractionation
Dose prescribed is 45 Gy in 25 fractions (1.8 Gy per fraction) delivered daily over 5 weeks.
• Hypofractionation
Dose prescribed is 30 Gy in 5 fractions (6 Gy per fraction) delivered every other day over 11 days. There will be a minimum of 36 hours and maximum of 96 hours between fractions. The entire course of treatment should be completed within no less than 10 days.

Locations

Country	Name	City	State
Canada	Royal Victoria Hospital	Barrie	Ontario
Canada	London Regional Cancer Program	London	Ontario
Canada	Credit Valley Hospital	Mississauga	Ontario
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (5)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Credit Valley Hospital, London Regional Cancer Program, Canada, Princess Margaret Hospital, Canada, Royal Victoria Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute bowel toxicity	To compare the acute bowel toxicities associated with hypofractionated vs conventional adjuvant pelvic radiation as measured by the The Expanded Prostate Cancer Index Composite (EPIC) questionnaire.	Baseline to 2 years following RT completion
Secondary	Acute bowel toxicities	To compare the acute bowel toxicities associated with hypofractionated treatment and conventional fractionation in adjuvant pelvic radiation for endometrial cancers using the Common Terminology Criteria for Adverse Events (CTCAE v5.0) criteria.	Baseline to 2 years following RT completion
Secondary	Acute urinary toxicities through CTCAE	To compare the acute urinary toxicities associated with hypofractionated treatment and conventional fractionation in adjuvant pelvic radiation for endometrial cancers using the Common Terminology Criteria for Adverse Events (CTCAE v5.0) criteria.	Baseline to 2 years following RT completion
Secondary	Acute urinary toxicities through EPIC	To compare the acute urinary toxicities associated with hypofractionated treatment and conventional fractionation in adjuvant pelvic radiation for uterine cancer as measured by EPIC.	Baseline to 2 years following RT completion
Secondary	Local- regional failure	To compare presence of tumour through physical exam or radiologic imaging between hypofractionated treatment and conventional fractionation.	Baseline to 2 years following RT completion
Secondary	Disease-free survival	To compare disease-free survival of hypofractionated treatment and conventional fractionation	Baseline to 2 years following RT completion
Secondary	Quality of life using EORTC QLQ-30 and endometrial module (EN-24)	To compare the effect of hypofractionated treatment and conventional fractionation on quality of life using the using EORTC (European Organisation for Research and Treatment of Cancer) core questionnaire (QLQ-C30) with EN-24 companion.	Baseline to 2 years following RT completion
Secondary	Correlation of GU toxicity, EORTC, and EPIC	To measure correlations between GU toxicity and EORTC questionnaire versus GU toxicity and EPIC questionnaire.	Baseline to 2 years following RT completion