Clinical trial NCT04567771: Comparison of Proton or Intensity Modulated Radiation Therapy After Surgery for Endometrial or Cervical Cancer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Carcinoma
Endometrial Carcinoma
Endometriosis
Pelvic Inflammatory Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-09-28
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Expanded Prostate Cancer Index Composite (EPIC) Bowel score
timeFrame: Baseline up to 3 years post-radiation therapy (RT)
Secondary outcomes:
measure: Bowel and bladder dose-volume histogram (DVH) parameters
timeFrame: Up to 3 years post-RT
measure: Change in EPIC Urinary score
timeFrame: Baseline up to 5 weeks
measure: Well-being
timeFrame: Up to 3 years post-RT
measure: Incidence of grade 2+ hematologic toxicities
timeFrame: Up to 3 years post-RT
measure: Progression-free survival
timeFrame: Up to 3 years post-RT
measure: Overall survival (OS)
timeFrame: Up to 3 years post-RT
measure: Change in overall patient quality of life
timeFrame: Baseline up to 3 years post-RT
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Allison E. Garda, M.D.
role: PRINCIPAL_INVESTIGATOR
References: