Cervical Cancer, Gynaecologic Cancer, Radiation Therapy
Conditions
Brief summary
The purpose of study is to compare the side effects of two different forms of radiation for endometrial and cervical cancer. If you decide to enroll in this study, you will be randomized to one of two treatment groups. This study will compare two standard of care treatments: "Conventional" pHoton radiation versus pRoton radiation.
Interventions
RADIATIONVolume Modulated Arc Therapy (VMAT)
VMAT RT- 45-50.4 Gy in 1.8-2 Gy fractions All patients will receive concurrent cisplatin 40 mg/m2 on a weekly basis during EBRT in accordance with standard of care. No chemotherapy will be utilized during HDR brachytherapy.
IMPT- 45-50.4 Gy in 1.8-2 Gy fractions All patients will receive concurrent cisplatin 40 mg/m2 on a weekly basis during EBRT in accordance with standard of care. No chemotherapy will be utilized during HDR brachytherapy.
Sponsors
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. a. Newly diagnosed endometrial cancer after TAH/BSO and nodal sampling, sentinel LN biopsy or pelvic nodal dissection planning to receive sequential chemotherapy and radiation or concurrent chemoradiotherapy or b. cervical cancer planning to receive definitive chemoradiation with HDR brachytherapy boost 2. Histologic confirmation of malignancy (primary only) 3. ≥ 18 years of age 4. ECOG performance status ≤ 2 5. Patient must have the ability to understand and the willingness to sign a written informed consent document or when appropriate, have an acceptable surrogate capable of giving consent on the subject's behalf. 6. Insurance approval for IMPT
Exclusion criteria
1. Metastatic disease beyond para-aortic lymph nodal region 2. Residual tumor after surgery exceeding 2 cm in maximum dimension in patients with endometrial cancer. 3. FIGO 2014 stage III-IVA cervix cancer planning to receive concurrent pembrolizumab. 4. Cervical cancer with inability to receive concurrent chemotherapy. 5. Any prior pelvic radiation. 6. Treatment with other investigational agents. 7. Carcinosarcoma. 8. Creatine clearance \<30 mL/m2 9. Unable to lie flat during or tolerate radiation. 10. Refusal to sign informed consent. 11. Any additional active cancer that would interfere with the primary study endpoints
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related Acute Gastrointestinal Toxicity as assessed by CTCAE v 5.0 | 2-years following completion of treatment | To compare patient reported acute gastrointestinal toxicity specifically grade 2 or higher (CTCAE) diarrhea events between IMPT and VMAT for patients receiving pelvic nodal irradiation for newly diagnosed cervical and endometrial cancer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of grade 4 (via CTCAE) lymphopenia during radiation between IMPT and VMAT | 2-year following completion of treatment | To compare the incidence of grade 4 lymphopenia during radiation between IMPT and VMAT for patients receiving pelvic nodal irradiation for newly diagnosed cervical and endometrial cancer. |
| Number of patients with decreased lymphocyte values at first follow-up visit post radiation | 3 months post completion of RT | To compare lymphocyte nadir at first follow-up visit after completion of radiation. |
| Number of patients with physician reported GI toxicities assessed by CTCAE v5 | 2 years post radiation treatment | To compare physician reported GI outcomes between arms. |
| Rates of treatment completion within scheduled time frame | 2 years post treament | To compare rates of treatment completion within scheduled time frame between arms. |
| GI, GU and hematologic grade 2 or higher late toxicity events (via CTCAE) | 2 years post treatment completion | To compare GI, GU and hematologic grade 2 or higher late toxicity events between arms. |
| Compare 2-year overall survival, local failure and distant failure | 2 years post treatment completion | To compare 2-year overall survival, local failure and distant failure between arms. |
Countries
United States
Contacts
CONTACTElizabeth Nichols, MD
CONTACTCaitlin Eggleston, MPH
PRINCIPAL_INVESTIGATORElizabeth Nichols, MD
University of Maryland Medical Center/Maryland Proton Treatment Center
Outcome results
None listed