Brief Title
Comparison of Acute Toxicities Between Patients Treated With Protons or Intensity Modulated Radiation Therapy After Surgery for the Treatment of 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
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.
Study Phase
Early Phase 1
Study Type
Interventional
Primary Outcome
Change in Expanded Prostate Cancer Index Composite (EPIC) Bowel score
Secondary Outcome
Bowel and bladder dose-volume histogram (DVH) parameters
Condition
Cervical Carcinoma
Intervention
Quality-of-Life Assessment
Study Arms / Comparison Groups
Treatment (radiation therapy, questionnaires)
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
120
Start Date
December 4, 2020
Completion Date
October 15, 2024
Primary Completion Date
October 15, 2023
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 an Institutional Review Board (IRB)-approved 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
- Patients with active and/or inflammatory irritable bowel disease
- 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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ivy A Petersen, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04567771
Organization ID
ROR1904
Secondary IDs
NCI-2020-06936
Responsible Party
Sponsor
Study Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Ivy A Petersen, Principal Investigator, Mayo Clinic in Rochester
Verification Date
June 2022