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

NCT04567771 | Recruiting

• 3 other identifiers: MC1961ROR190419-004792
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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.

Conditions

Pelvic Inflammatory Disease; Cervical Carcinoma; Endometrial Carcinoma; Endometriosis

Outcome Measures

Primary Outcomes (1)

• Change in Expanded Prostate Cancer Index Composite (EPIC) Bowel score

  Will be examined using analysis of covariance.

  Baseline up to 3 years post-radiation therapy (RT)

Secondary Outcomes (7)

• Bowel and bladder dose-volume histogram (DVH) parameters

  Up to 3 years post-RT

• Change in EPIC Urinary score

  Baseline up to 5 weeks

• Well-being

  Up to 3 years post-RT

• Incidence of grade 2+ hematologic toxicities

  Up to 3 years post-RT

• Progression-free survival

  Up to 3 years post-RT

Study Arms (1)

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.

Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Radiation Therapy

Interventions

Quality-of-Life Assessment OTHER

Complete quality of life questionnaires

Also known as: Quality of Life Assessment

Treatment (radiation therapy, questionnaires)

Questionnaire Administration OTHER

Complete adverse event assessments

Treatment (radiation therapy, questionnaires)

Radiation Therapy RADIATION

Undergo proton or intensity modulated radiation therapy

Also known as: Cancer Radiotherapy, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation

Treatment (radiation therapy, questionnaires)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

ACTIVE NOT RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Endometrial Neoplasms; Endometriosis; Pelvic Inflammatory Disease

Interventions

Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pelvic Infection; Infections; Adnexal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Phenomena

Study Officials

• Allison E. Garda, M.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: September 28, 2020
• Study Start: December 4, 2020
• Primary Completion (Estimated): October 15, 2028
• Study Completion (Estimated): October 15, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

US (3)