Cervical CarcinomaNCT04567771
Comparison of Proton or Intensity Modulated Radiation Therapy After Surgery for Endometrial or Cervical Cancer
A study testing Quality-of-Life Assessment, Questionnaire Administration and Radiation Therapy in people with Cervical Carcinoma and Endometrial Carcinoma, run by Mayo Clinic at 3 sites in United States.
Trial summary
This early phase I trial compares the side effects between patients treated with proton radiation therapy versus intensity modulated radiation therapy after surgery for the treatment of endometrial or cervical cancer. Radiation therapy uses high energy protons or x-rays to kill tumor cells and shrink tumors. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Carcinoma, Endometrial Carcinoma, Endometriosis
- What is being tested?
- Quality-of-Life Assessment, Questionnaire Administration and Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 Dec 2020to 1 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Documentation of history of:
- Smoking status
- Pelvic infection
Show all 16Show fewer
- Pelvic inflammatory disease
- Endometriosis
- Planned to receive either proton or IMRT radiation treatment, with use of rectal balloon, at any 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
Who cannot join
- 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
- Positive or close surgical margins (=< 3 mm)
Show all 17Show fewer
- 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
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 1 recruiting
- Active, not recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referra Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Allison E. Garda, M.D.
- Active, not recruiting
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
About this study
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
This early phase I trial compares the side effects between patients treated with proton radiation therapy versus intensity modulated radiation therapy after surgery for the treatment of endometrial or cervical cancer. Radiation therapy uses high energy protons or x-rays to kill tumor cells and shrink tumors. Using quality of life questionnaires and adverse event assessments may help doctors learn whether proton radiation therapy is associated with lower acute gastrointestinal toxicities at the end of treatment compared to intensity modulated radiation therapy in patients with endometrial or cervical cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- 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:
- 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.
- 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.
- Being tested
- Quality-of-Life Assessment, Questionnaire Administration, Radiation Therapy
- Medical subject headings
- Uterine Cervical Neoplasms, Endometrial Neoplasms, Endometriosis, Pelvic Inflammatory Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Complete quality of life questionnaires
Questionnaire AdministrationOther
Complete adverse event assessments
Radiation TherapyRadiation
Also called Cancer Radiotherapy, ENERGY_TYPE, Irradiate, Irradiated
Undergo proton or intensity modulated radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Treatment (radiation therapy, questionnaires) | Experimental | 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. Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Expanded Prostate Cancer Index Composite (EPIC) Bowel score
Will be examined using analysis of covariance.
Measured: Baseline up to 3 years post-radiation therapy (RT)
Secondary outcomes (7)
Bowel and bladder dose-volume histogram (DVH) parameters
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.
Measured: Up to 3 years post-RT
Change in EPIC Urinary score
Will be examined using analysis of covariance.
Measured: Baseline up to 5 weeks
Well-being
Measured by the Functional Assessment of Cancer Therapy cervix domain. Will be examined using analysis of covariance.
Measured: Up to 3 years post-RT
Incidence of grade 2+ hematologic toxicities
Measured by Common Terminology Criteria for Adverse Events version 4.0. Will be examined using logistic regression.
Measured: Up to 3 years post-RT
Progression-free survival
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]).
Measured: Up to 3 years post-RT
Overall survival (OS)
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).
Measured: Up to 3 years post-RT
Change in overall patient quality of life
Measured by the European Quality of Life Five Dimension Five Level Scale Questionnaire. Will be examined using analysis of covariance.
Measured: Baseline up to 3 years post-RT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start4 Dec 2020
- Primary completion1 Apr 2029 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 121 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Allison E. Garda, M.D., Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04567771
- Sponsor's protocol ID
- MC1961
- Other IDs
- ROR1904, 19-004792
- Status last verified
- Jul 2026
- First submitted
- 23 Sep 2020
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04567771
- Acronym / sponsor ID
- MC1961
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 121 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 4 Dec 2020 (actual)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 28 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This early phase I trial compares the side effects between patients treated with proton radiation therapy versus intensity modulated radiation therapy after surgery for the treatment of endometrial or cervical cancer. Radiation therapy uses high energy protons or x-rays to kill tumor cells and shrink tumors. Using quality of life questionnaires and adverse event assessments may help doctors learn whether proton radiation therapy is associated with lower acute gastrointestinal toxicities at the end of treatment compared to intensity modulated radiation therapy in patients with endometrial or cervical cancer.
Detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- 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:
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (radiation therapy, questionnaires) | Experimental | Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Radiation: Radiation TherapyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
- Documentation of history of:
- Planned to receive either proton or IMRT radiation treatment, with use of rectal balloon, at any Mayo Clinic site
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentComplete quality of life questionnaires | Other | Treatment (radiation therapy, questionnaires) |
| Questionnaire AdministrationComplete adverse event assessments | Other | Treatment (radiation therapy, questionnaires) |
| Radiation TherapyAlso: Cancer Radiotherapy, ENERGY_TYPE, Irradiate, IrradiatedUndergo proton or intensity modulated radiation therapy | Radiation | Treatment (radiation therapy, questionnaires) |
Primary outcome
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.
7 secondary outcomes
Bowel and bladder dose-volume histogram (DVH) parameters
Time frame: Up to 3 years post-RT
Change in EPIC Urinary score
Time frame: Baseline up to 5 weeks
Well-being
Time frame: Up to 3 years post-RT
Incidence of grade 2+ hematologic toxicities
Time frame: Up to 3 years post-RT
Progression-free survival
Time frame: Up to 3 years post-RT
Overall survival (OS)
Time frame: Up to 3 years post-RT
Change in overall patient quality of life
Time frame: Baseline up to 3 years post-RT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Cervical Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Allison E. Garda, M.D. principal investigator
Mayo Clinic in Rochester
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality-of-Life Assessment, Questionnaire Administration and Radiation Therapy in people with Cervical Carcinoma and Endometrial Carcinoma, run by Mayo Clinic at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Expanded Prostate Cancer Index Composite (EPIC) Bowel score (time frame: Baseline up to 3 years post-radiation therapy (RT)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.