SPARTACUSII: Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus II
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Conventional Fractionation Pelvic Radiation Patients randomized to the conventional fractionation arm will be treated with intensity-modulated or volumetric arc therapy technique as per standard protocol. |
Radiation: Conventional Fractionation
Dose prescribed is 45 Gy in 25 fractions (1.8 Gy per fraction) delivered daily over 5 weeks.
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| Experimental: Stereotactic Hypofractionated Radiation Patients randomized to hypofractionation will be treated the stereotactic hypofractionated technique. |
Radiation: 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.
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Outcome Measures
Primary Outcome Measures
- Acute bowel toxicity [Baseline to 2 years following RT completion]
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.
Secondary Outcome Measures
- Acute bowel toxicities [Baseline to 2 years following RT completion]
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.
- Acute urinary toxicities through CTCAE [Baseline to 2 years following RT completion]
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.
- Acute urinary toxicities through EPIC [Baseline to 2 years following RT completion]
To compare the acute urinary toxicities associated with hypofractionated treatment and conventional fractionation in adjuvant pelvic radiation for uterine cancer as measured by EPIC.
- Local- regional failure [Baseline to 2 years following RT completion]
To compare presence of tumour through physical exam or radiologic imaging between hypofractionated treatment and conventional fractionation.
- Disease-free survival [Baseline to 2 years following RT completion]
To compare disease-free survival of hypofractionated treatment and conventional fractionation
- Quality of life using EORTC QLQ-30 and endometrial module (EN-24) [Baseline to 2 years following RT completion]
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.
- Correlation of GU toxicity, EORTC, and EPIC [Baseline to 2 years following RT completion]
To measure correlations between GU toxicity and EORTC questionnaire versus GU toxicity and EPIC questionnaire.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient with histologically confirmed endometrial adenocarcinoma, serous or clear cell carcinoma.
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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.
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Patients who are to receive adjuvant systemic therapy sequentially in addition to pelvic radiotherapy will be eligible.
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Age ≥18 years.
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Patient is willing and able to give informed consent to participate in this clinical trial.
Exclusion Criteria:
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Patient has had prior pelvic radiotherapy.
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Patient has a contraindication to pelvic radiotherapy, such as but not limited to a connective tissue disease or inflammatory bowel disease.
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Patient planned for concurrent chemoradiation therapy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Royal Victoria Hospital | Barrie | Ontario | Canada | L4M 6M2 |
| 2 | London Regional Cancer Program | London | Ontario | Canada | N6A 5W9 |
| 3 | Credit Valley Hospital | Mississauga | Ontario | Canada | L5M 2N1 |
| 4 | Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada | M4N 3M5 |
| 5 | Princess Margaret Cancer Centre | Toronto | Ontario | Canada | M5G 2C1 |
Sponsors and Collaborators
- Sunnybrook Health Sciences Centre
- Princess Margaret Hospital, Canada
- Royal Victoria Hospital, Canada
- Credit Valley Hospital
- London Regional Cancer Program, Canada
Investigators
- Principal Investigator: Eric Leung, MD, Sunnybrook Health Sciences Centre
- Principal Investigator: Kathy Han, MD, Princess Margaret Cancer Centre
- Principal Investigator: Adam Gladwish, MD, Royal Victoria Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SPARTACUS II