Cervical Carcinoma, Endometrial Carcinoma, Endometriosis, Pelvic Inflammatory Disease
Conditions
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.
Interventions
OTHERQuality-of-Life Assessment
Complete quality of life questionnaires
OTHERQuestionnaire Administration
Complete adverse event assessments
RADIATIONRadiation Therapy
Undergo proton or intensity modulated radiation therapy
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Expanded Prostate Cancer Index Composite (EPIC) Bowel score | Baseline up to 3 years post-radiation therapy (RT) | Will be examined using analysis of covariance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bowel and bladder dose-volume histogram (DVH) parameters | 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 | Baseline up to 5 weeks | Will be examined using analysis of covariance. |
| Well-being | 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 | 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 | 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) | 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 | 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. |
Countries
United States
Contacts
CONTACTClinical Trials Referral Office
PRINCIPAL_INVESTIGATORAllison E. Garda, M.D.
Mayo Clinic in Rochester
Outcome results
None listed