Comparison of Acute Toxicities Between Patients Treated With Protons or Intensity Modulated Radiation Therapy After Surgery for the Treatment of Endometrial or Cervical Cancer
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ClinicalTrials.gov Identifier: NCT04567771 |
Recruitment Status :
Recruiting
First Posted : September 28, 2020
Last Update Posted : January 22, 2021
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Condition or disease | Intervention/treatment | Phase |
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Cervical Carcinoma Endometrial Carcinoma Endometriosis Pelvic Inflammatory Disease | Other: Quality-of-Life Assessment Other: Questionnaire Administration Radiation: Radiation Therapy | Early Phase 1 |
PRIMARY OBJECTIVE:
I. To assess whether proton radiation therapy (RT) is associated with lower acute gastrointestinal toxicities at the end of treatment compared to intensity modulated radiation therapy (IMRT) as measured with the Expanded Prostate Cancer Index Composite (EPIC) bowel domain.
SECONDARY OBJECTIVES:
I. To examine the association of bowel and bladder dose-volume histogram (DVH) with bowel and bladder toxicities, respectively.
II. To assess whether urinary toxicity rate is improved with proton RT compared to IMRT as measured with the EPIC urinary domain.
III. To determine if well-being is improved with proton RT compared to IMRT as measured by the Functional Assessment of Cancer Therapy (FACT) cervix domain.
IV. To determine if proton RT reduces grade 2+ hematologic toxicities (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.0) compared to IMRT.
V. Evaluate progression-free and overall survival between patients receiving proton RT and IMRT.
VI. To determine if proton RT improves overall patient quality of life compared to IMRT using the European Quality of Life Five Dimension (EQ-5D) questionnaire.
EXPLORATORY OBJECTIVES:
I. Evaluate ability to tolerate chemotherapy concurrent or after RT. II. Correlate bone marrow DVH with blood marrow function, and ability to tolerate chemotherapy concurrently or after RT.
III. Correlate bowel and skin DVH with acute toxicity. IV. To evaluate patient-reported gastrointestinal (GI) toxicities as a predictor of assigned treatment regimen, as well as physician-reported GI toxicities as a predictor of assigned treatment regimen.
V. Confirm the validity of the EPIC bowel and urinary domains when referencing the last 7 days.
OUTLINE:
Patients undergo standard of care proton or intensity modulated radiation therapy. Patients also complete quality of life questionnaires and adverse event assessments over 10-15 minutes each at baseline, at the end of radiation therapy, and at 1 month, 1 year, and 3 years post-radiation therapy.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Comparison of Acute Toxicities Between Patients Treated With Protons or Intensity-Modulated Radiation Therapy for Post-Operative Treatment of Endometrial or Cervical Cancers |
Actual Study Start Date : | December 4, 2020 |
Estimated Primary Completion Date : | October 15, 2023 |
Estimated Study Completion Date : | October 15, 2024 |

Arm | Intervention/treatment |
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Experimental: Treatment (radiation therapy, questionnaires)
Patients undergo standard of care proton or intensity modulated radiation therapy. Patients also complete quality of life questionnaires and adverse event assessments over 10-15 minutes each at baseline, at the end of radiation therapy, and at 1 month, 1 year, and 3 years post-radiation therapy.
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Other: Quality-of-Life Assessment
Complete quality of life questionnaires
Other Name: Quality of Life Assessment Other: Questionnaire Administration Complete adverse event assessments Radiation: Radiation Therapy Undergo proton or intensity modulated radiation therapy
Other Names:
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- Change in Expanded Prostate Cancer Index Composite (EPIC) Bowel score [ Time Frame: Baseline up to 3 years post-radiation therapy (RT) ]Will be examined using analysis of covariance.
- Bowel and bladder dose-volume histogram (DVH) parameters [ Time Frame: Up to 3 years post-RT ]Will be examined in association with the change in EPIC Bowel and Urinary scores using analysis of covariance, considering the DVH variables as model covariates.
- Change in EPIC Urinary score [ Time Frame: Baseline up to 5 weeks ]Will be examined using analysis of covariance.
- Well-being [ Time Frame: Up to 3 years post-RT ]Measured by the Functional Assessment of Cancer Therapy cervix domain. Will be examined using analysis of covariance.
- Incidence of grade 2+ hematologic toxicities [ Time Frame: Up to 3 years post-RT ]Measured by Common Terminology Criteria for Adverse Events version 4.0. Will be examined using logistic regression.
- Progression-free survival [ Time Frame: Up to 3 years post-RT ]Will be examined using survival methods. Cumulative probability of progression rates will be calculated treating death as a competing risk. Cox models will be used to assess the association of treatment received (proton RT versus intensity modulated radiation therapy [IMRT]).
- Overall survival (OS) [ Time Frame: Up to 3 years post-RT ]Will be examined using survival methods. Estimates of OS will be calculated using the Kaplan Meier method. Cox models will be used to assess the association of treatment received (proton RT versus IMRT).
- Change in overall patient quality of life [ Time Frame: Baseline up to 3 years post-RT ]Measured by the European Quality of Life Five Dimension Five Level Scale Questionnaire. Will be examined using analysis of covariance.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically confirmed diagnosis of cervical or endometrial cancer
- Must have undergone an open or robotic hysterectomy (total abdominal, vaginal, radical, or total laparoscopic) for carcinoma of the cervix or endometrium
- History and physical prior to registration
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Documentation of history of:
- Smoking status
- Pelvic infection
- Pelvic inflammatory disease
- Endometriosis
- Planned to receive either proton or IMRT radiation treatment, with use of rectal balloon, at an Institutional Review Board (IRB)-approved Mayo Clinic site
- Plan for RT to pelvis with or without para-aortic lymph node irradiation
- If received high-dose chemotherapy prior to registration, last dose must have been given >= 21 days prior to start of RT
- Complete blood count (CBC) performed within 21 days prior to registration
- Computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET)/CT, or PET/MRI for staging before registration; may be pre-operative (op) or post-op
- Eastern Cooperative Oncology Group (ECOG) performance score 0-2
- Provide written informed consent
- Willing to complete quality of life (QOL) questionnaires
Exclusion Criteria:
- Receiving external beam boost dose during RT
- Distant metastases
- Gross disease at time of RT
- Histology of endometrial stromal sarcoma, leiomyosarcoma, melanoma or small cell carcinomas
- Patients who exceed the weight/size limits of the treatment table
- Patients with active and/or inflammatory irritable bowel disease
- Positive or close surgical margins (=< 3 mm)
- Prior RT to the pelvis
- Planned to receive inguinal node RT
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note that human immunodeficiency virus (HIV) testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be immunosuppressive
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
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Severe, active co-morbidity defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Other major medical illness which requires hospitalization or precludes study therapy at the time of registration
- Patients unwilling to have rectal balloon placed on a daily basis during RT

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04567771
United States, Arizona | |
Mayo Clinic Arizona | Recruiting |
Scottsdale, Arizona, United States, 85259 | |
Contact: Clincial Trials Referral Office 855-776-0015 mayocliniccancerstudies@mayo.edu | |
Principal Investigator: Sujay A. Vora, M.D. | |
United States, Florida | |
Mayo Clinic Florida | Recruiting |
Jacksonville, Florida, United States, 32224 | |
Contact: Clinical Trials Referral Office 855-776-0015 mayocliniccancerstudies@mayo.edu | |
Principal Investigator: Katherine S. Tzou, M.D. | |
United States, Minnesota | |
Mayo Clinic in Rochester | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Clinical Trials Referral Office 855-776-0015 mayocliniccancerstudies@mayo.edu | |
Principal Investigator: Ivy A. Petersen, M.D. |
Principal Investigator: | Ivy A Petersen | Mayo Clinic in Rochester |
Responsible Party: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT04567771 |
Other Study ID Numbers: |
ROR1904 NCI-2020-06936 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) ROR1904 ( Other Identifier: Mayo Clinic in Rochester ) P30CA015083 ( U.S. NIH Grant/Contract ) |
First Posted: | September 28, 2020 Key Record Dates |
Last Update Posted: | January 22, 2021 |
Last Verified: | December 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Pelvic Inflammatory Disease Pelvic Infection Carcinoma Uterine Cervical Neoplasms Endometrial Neoplasms Endometriosis Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Uterine Cervical Diseases Uterine Diseases Infection Adnexal Diseases |