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Hypofractionated Radiotherapy for the Treatment of Cervical or Endometrial Cancer (RT-PACE)

Primary Purpose

Cervical Carcinoma, Endometrial Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hypofractionated Radiation Therapy
Sponsored by
University of Utah
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:

  • Subjects aged >= 18 years
  • Pathologically confirmed malignancy of the cervix or endometrium. Non-epithelial histologies are permitted. Adenocarcinoma in situ is also permitted
  • Patients must be status post hysterectomy for initial management of cervix or endometrial cancer
  • Subject must have non-metastatic disease as determined by clinical exam or computed tomography (CT) or positron emission tomography (PET)/CT imaging
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • Recovery to baseline or =< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 from toxicities related to any prior cancer therapy, unless considered clinically not significant by the treating investigator
  • Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines
  • Life expectancy of > 2 years
  • Chemotherapy can be administered at discretion of the treating radiation, medical, or gynecologic oncologist. Sequential therapy (radiation followed by chemotherapy) is preferred but not required

Exclusion Criteria:

  • Prior abdominal or pelvic irradiation
  • Interval between the hysterectomy and planned start of radiotherapy exceeding 16 weeks, unless chemotherapy is administered prior to RT. If chemotherapy is administered prior to RT, consult with PI regarding acceptable time frame.
  • Prior history of inflammatory bowel disease
  • The diagnosis of another malignancy within =< 2 years before study enrollment, except for those considered to be adequately treated with no evidence of disease or symptoms and/or will not require therapy during the study duration (i.e., basal cell or squamous cell skin cancer, carcinoma in situ of the breast, or bladder or of the cervix)
  • Medical, psychiatric, cognitive, or other conditions in the opinion of the investigator that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study

Sites / Locations

  • Huntsman Cancer Institute/University of UtahRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (hypo-fractionated radiotherapy)

Arm Description

Patients undergo hypo-fractionated radiotherapy over 3 weeks in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Change in toxicity
Will be measured with the bowel domain of the Expanded Prostate Cancer Index Composite (EPIC) instrument.
Ability to administer clinical trial to evaluate hypofractionated radiotherapy
Will be measured by percent of eligible patients who begin treatment that complete baseline visit and 3-week EPIC bowel domain questionnaire.

Secondary Outcome Measures

Change in urinary domain of the Expanded Prostate Cancer Index Composite (EPIC) instrument
estimate impact on acute and 1 year urinary toxicity
Change in gastrointestinal toxicities as collected through Patient-Reported Outcomes instruments (PRO-CTCAE)
estimate impact upon patient reported gastrointestinal toxicities
Change in Functional Assessment of Cancer Therapy-Cervix (FACT-Cx)
To assess acute and 1 year quality of life following treatment.
Change in COST-FACIT Measure of Financial Toxicity
To assess acute and 1 year quality of life following treatment
Decision Regret Scale- summary score
To assess satisfaction with decision-making following treatment.
Overall survival
Will use the Kaplan-Meier method to estimate overall survival throughout three years from the time of completing treatment.

Full Information

First Posted
November 18, 2021
Last Updated
August 2, 2023
Sponsor
University of Utah
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05139368
Brief Title
Hypofractionated Radiotherapy for the Treatment of Cervical or Endometrial Cancer
Acronym
RT-PACE
Official Title
RT-PACE: A Pilot Study of Adjuvant Hypo-Fractionated Radiotherapy for Non-Metastatic Cervical and Endometrial Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 11, 2021 (Actual)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
November 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Utah
Collaborators
National Cancer Institute (NCI)

4. Oversight

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

5. Study Description

Brief Summary
This clinical trial studies the feasibility of using hypo-fractionated radiotherapy for the treatment of cervical or endometrial cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.
Detailed Description
PRIMARY OBJECTIVE: I. To establish the trial as feasible and to assess the impact upon acute gastrointestinal toxicity in the third week of pelvic radiotherapy following a hypo-fractionated schedule. SECODARY OBJECTIVES: I. To estimate impact upon acute urinary toxicity. II. To estimate impact upon patient reported gastrointestional toxicity. III. To assess acute quality of life following treatment. IV. To quantify acute financial toxicity following treatment. V. To assess satisfaction with decision-making following treatment. VI. To assess the overall survival throughout 3 years of post-treatment follow-up. OUTLINE: Patients undergo hypo-fractionated radiotherapy over 3 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 1, 3, and 6 months and then at 1, 2, and 3 years.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (hypo-fractionated radiotherapy)
Arm Type
Experimental
Arm Description
Patients undergo hypo-fractionated radiotherapy over 3 weeks in the absence of disease progression or unacceptable toxicity.
Intervention Type
Radiation
Intervention Name(s)
Hypofractionated Radiation Therapy
Other Intervention Name(s)
Hypofractionated, Hypofractionated Radiotherapy, hypofractionation, Radiation, Hypofractionated
Intervention Description
Undergo hypofractionated radiation therapy
Primary Outcome Measure Information:
Title
Change in toxicity
Description
Will be measured with the bowel domain of the Expanded Prostate Cancer Index Composite (EPIC) instrument.
Time Frame
Baseline to week 3 of pelvic radiotherapy
Title
Ability to administer clinical trial to evaluate hypofractionated radiotherapy
Description
Will be measured by percent of eligible patients who begin treatment that complete baseline visit and 3-week EPIC bowel domain questionnaire.
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Change in urinary domain of the Expanded Prostate Cancer Index Composite (EPIC) instrument
Description
estimate impact on acute and 1 year urinary toxicity
Time Frame
Baseline to week 3 and 1 year
Title
Change in gastrointestinal toxicities as collected through Patient-Reported Outcomes instruments (PRO-CTCAE)
Description
estimate impact upon patient reported gastrointestinal toxicities
Time Frame
Baseline to week 3 and 1 year
Title
Change in Functional Assessment of Cancer Therapy-Cervix (FACT-Cx)
Description
To assess acute and 1 year quality of life following treatment.
Time Frame
Baseline to week 3 and 1 year
Title
Change in COST-FACIT Measure of Financial Toxicity
Description
To assess acute and 1 year quality of life following treatment
Time Frame
Baseline to week 3 and 1 year
Title
Decision Regret Scale- summary score
Description
To assess satisfaction with decision-making following treatment.
Time Frame
At week 3 and 1 year
Title
Overall survival
Description
Will use the Kaplan-Meier method to estimate overall survival throughout three years from the time of completing treatment.
Time Frame
Time to the earliest of all-cause mortality (event), end of study follow-up (censoring criteria), or loss to follow-up (censoring criteria), assessed up to 3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects aged >= 18 years Pathologically confirmed malignancy of the cervix or endometrium. Non-epithelial histologies are permitted. Adenocarcinoma in situ is also permitted Patients must be status post hysterectomy for initial management of cervix or endometrial cancer Subject must have non-metastatic disease as determined by clinical exam or computed tomography (CT) or positron emission tomography (PET)/CT imaging Eastern Cooperative Oncology Group (ECOG) performance status =< 2 Recovery to baseline or =< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 from toxicities related to any prior cancer therapy, unless considered clinically not significant by the treating investigator Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines Life expectancy of > 2 years Chemotherapy can be administered at discretion of the treating radiation, medical, or gynecologic oncologist. Sequential therapy (radiation followed by chemotherapy) is preferred but not required Exclusion Criteria: Prior abdominal or pelvic irradiation Interval between the hysterectomy and planned start of radiotherapy exceeding 16 weeks, unless chemotherapy is administered prior to RT. If chemotherapy is administered prior to RT, consult with PI regarding acceptable time frame. Prior history of inflammatory bowel disease The diagnosis of another malignancy within =< 2 years before study enrollment, except for those considered to be adequately treated with no evidence of disease or symptoms and/or will not require therapy during the study duration (i.e., basal cell or squamous cell skin cancer, carcinoma in situ of the breast, or bladder or of the cervix) Medical, psychiatric, cognitive, or other conditions in the opinion of the investigator that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel Kingsford
Phone
801-585-0115
Email
rachel.kingsford@hci.utah.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gita Suneja, MD
Organizational Affiliation
Huntsman Cancer Institute/ University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huntsman Cancer Institute/University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gita Suneja
Phone
801-585-0255
Email
Gita.suneja@hci.utah.edu
First Name & Middle Initial & Last Name & Degree
Gita Suneja

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Hypofractionated Radiotherapy for the Treatment of Cervical or Endometrial Cancer

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