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

Primary Purpose

Cervical Carcinoma, Endometrial Carcinoma, Endometriosis

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Quality-of-Life Assessment
Questionnaire Administration
Radiation Therapy
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic in ArizonaRecruiting
  • Mayo Clinic in FloridaRecruiting
  • Mayo Clinic in RochesterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (radiation therapy, questionnaires)

Arm 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.

Outcomes

Primary Outcome Measures

Change in Expanded Prostate Cancer Index Composite (EPIC) Bowel score
Will be examined using analysis of covariance.

Secondary Outcome Measures

Bowel and bladder dose-volume histogram (DVH) parameters
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
Will be examined using analysis of covariance.
Well-being
Measured by the Functional Assessment of Cancer Therapy cervix domain. Will be examined using analysis of covariance.
Incidence of grade 2+ hematologic toxicities
Measured by Common Terminology Criteria for Adverse Events version 4.0. Will be examined using logistic regression.
Progression-free survival
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)
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
Measured by the European Quality of Life Five Dimension Five Level Scale Questionnaire. Will be examined using analysis of covariance.

Full Information

First Posted
September 23, 2020
Last Updated
September 11, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04567771
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 4, 2020 (Actual)
Primary Completion Date
October 15, 2024 (Anticipated)
Study Completion Date
October 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Carcinoma, Endometrial Carcinoma, Endometriosis, Pelvic Inflammatory Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (radiation therapy, questionnaires)
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Complete quality of life questionnaires
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Complete adverse event assessments
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Other Intervention Name(s)
Cancer Radiotherapy, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation
Intervention Description
Undergo proton or intensity modulated radiation therapy
Primary Outcome Measure Information:
Title
Change in Expanded Prostate Cancer Index Composite (EPIC) Bowel score
Description
Will be examined using analysis of covariance.
Time Frame
Baseline up to 3 years post-radiation therapy (RT)
Secondary Outcome Measure Information:
Title
Bowel and bladder dose-volume histogram (DVH) parameters
Description
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.
Time Frame
Up to 3 years post-RT
Title
Change in EPIC Urinary score
Description
Will be examined using analysis of covariance.
Time Frame
Baseline up to 5 weeks
Title
Well-being
Description
Measured by the Functional Assessment of Cancer Therapy cervix domain. Will be examined using analysis of covariance.
Time Frame
Up to 3 years post-RT
Title
Incidence of grade 2+ hematologic toxicities
Description
Measured by Common Terminology Criteria for Adverse Events version 4.0. Will be examined using logistic regression.
Time Frame
Up to 3 years post-RT
Title
Progression-free survival
Description
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]).
Time Frame
Up to 3 years post-RT
Title
Overall survival (OS)
Description
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).
Time Frame
Up to 3 years post-RT
Title
Change in overall patient quality of life
Description
Measured by the European Quality of Life Five Dimension Five Level Scale Questionnaire. Will be examined using analysis of covariance.
Time Frame
Baseline up to 3 years post-RT

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivy A Petersen
Organizational Affiliation
Mayo Clinic in Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Sujay A. Vora, M.D.
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224-9980
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Katherine S. Tzou, M.D.
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referra Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Ivy A. Petersen, M.D.

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

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