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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Photon Radiation | Active Comparator | Photon Radiation Therapy (Volume Modulated Arc Therapy (VMAT)) |
|
| Proton Radiation | Active Comparator | Proton Radiation Therapy (Intensity Modulated Proton Therapy (IMPT)) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Volume Modulated Arc Therapy (VMAT) | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related Acute Gastrointestinal Toxicity as assessed by CTCAE v 5.0 | 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. | 2-years following completion of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of grade 4 (via CTCAE) lymphopenia during radiation between IMPT and VMAT | 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. | 2-year following completion of treatment |
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Inclusion Criteria:
Exclusion Criteria:
Biologically female- study is for patients with gynecological cancer
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Nichols, MD | Contact | 410-328-6080 | enichols1@umm.edu | |
| Caitlin Eggleston, MPH | Contact | 410-369-5351 | caitlineggleston@umm.edu |
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Nichols, MD | University of Maryland Medical Center/Maryland Proton Treatment Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maryland Proton Treatment Center | Baltimore | Maryland | 21201 | United States | ||
| University of Maryland Greenebaum Cancer Center |
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|
| Intensity Modulated Proton Therapy (IMPT) | Radiation | 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. |
|
|
| Number of patients with decreased lymphocyte values at first follow-up visit post radiation |
To compare lymphocyte nadir at first follow-up visit after completion of radiation. |
| 3 months post completion of RT |
| Number of patients with physician reported GI toxicities assessed by CTCAE v5 | To compare physician reported GI outcomes between arms. | 2 years post radiation treatment |
| Rates of treatment completion within scheduled time frame | To compare rates of treatment completion within scheduled time frame between arms. | 2 years post treament |
| GI, GU and hematologic grade 2 or higher late toxicity events (via CTCAE) | To compare GI, GU and hematologic grade 2 or higher late toxicity events between arms. | 2 years post treatment completion |
| Compare 2-year overall survival, local failure and distant failure | To compare 2-year overall survival, local failure and distant failure between arms. | 2 years post treatment completion |
| Baltimore |
| Maryland |
| 21201 |
| United States |
| Upper Chesapeake Health | Bel Air | Maryland | 21014 | United States |
| Central Maryland Radiation Oncology | Columbia | Maryland | 21044 | United States |
| Baltimore Washington Medical Center- Tate Cancer Center | Glen Burnie | Maryland | 21061 | United States |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| C000608097 | DMAC2L protein, human |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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