Comparison of Proton or Intensity Modulated Radiation Therapy After Surgery for Endometrial or Cervical Cancer

NCT ID: NCT04567771

Last Updated: 2025-11-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-04
• Study Completion Date: 2028-10-15

Brief 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. 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:

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.

Conditions

Cervical Carcinoma; Endometrial Carcinoma; Endometriosis; Pelvic Inflammatory Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Quality-of-Life Assessment

Intervention Type: OTHER

Complete quality of life questionnaires

Questionnaire Administration

Intervention Type: OTHER

Complete adverse event assessments

Radiation Therapy

Intervention Type: RADIATION

Undergo proton or intensity modulated radiation therapy

Interventions

Quality-of-Life Assessment

Complete quality of life questionnaires

Intervention Type: OTHER

Questionnaire Administration

Complete adverse event assessments

Intervention Type: OTHER

Radiation Therapy

Undergo proton or intensity modulated radiation therapy

Intervention Type: RADIATION

Other Intervention Names

Quality of Life Assessment; Cancer Radiotherapy; ENERGY_TYPE; Irradiate; Irradiated; Irradiation; Radiation; Radiation Therapy, NOS; Radiotherapeutics; Radiotherapy; RT; Therapy, Radiation

Eligibility Criteria

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
• 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 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

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
• 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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Allison E. Garda, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Locations

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Site Status: RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status: ACTIVE_NOT_RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Clinical Trials Referral Office

Role: CONTACT

mayocliniccancerstudies@mayo.edu

855-776-0015

Facility Contacts

Clinical Trials Referral Office

Role: primary

mayocliniccancerstudies@mayo.edu

855-776-0015

Clinical Trials Referra Office

Role: primary

mayocliniccancerstudies@mayo.edu

855-776-0015

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

NCI-2020-06936

Identifier Type: REGISTRY

Identifier Source: secondary_id

ROR1904

Identifier Type: OTHER

Identifier Source: secondary_id

19-004792

Identifier Type: OTHER

Identifier Source: secondary_id

MC1961

Identifier Type: OTHER

Identifier Source: secondary_id

MC1961

Identifier Type: -

Identifier Source: org_study_id

NCT04745650

Identifier Type: -

Identifier Source: nct_alias