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

RT-PACE: A Pilot Study of Adjuvant Hypo-Fractionated Radiotherapy for Non-Metastatic Cervical and Endometrial Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Cervical Carcinoma; Endometrial Carcinoma
• Intervention / Treatment: Radiation: Hypofractionated Radiation Therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rachel Kingsford; Phone Number: 801-585-0115; Email: rachel.kingsford@hci.utah.edu

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Recruiting
      • Huntsman Cancer Institute/University of Utah
      • Contact: Gita Suneja; Phone Number: 801-585-0255; Email: Gita.suneja@hci.utah.edu
      • Principal Investigator: Gita Suneja

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment (hypo-fractionated radiotherapy); Patients undergo hypo-fractionated radiotherapy over 3 weeks in the absence of disease progression or unacceptable toxicity.	Radiation: Hypofractionated Radiation Therapy; Undergo hypofractionated radiation therapy; Other Names: Hypofractionated Radiotherapy; hypofractionation; Radiation, Hypofractionated; Hypofractionated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in toxicity	Will be measured with the bowel domain of the Expanded Prostate Cancer Index Composite (EPIC) instrument.	Baseline to week 3 of pelvic radiotherapy
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.	Up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in urinary domain of the Expanded Prostate Cancer Index Composite (EPIC) instrument	estimate impact on acute and 1 year urinary toxicity	Baseline to week 3 and 1 year
Change in gastrointestinal toxicities as collected through Patient-Reported Outcomes instruments (PRO-CTCAE)	estimate impact upon patient reported gastrointestinal toxicities	Baseline to week 3 and 1 year
Change in Functional Assessment of Cancer Therapy-Cervix (FACT-Cx)	To assess acute and 1 year quality of life following treatment.	Baseline to week 3 and 1 year
Change in COST-FACIT Measure of Financial Toxicity	To assess acute and 1 year quality of life following treatment	Baseline to week 3 and 1 year
Decision Regret Scale- summary score	To assess satisfaction with decision-making following treatment.	At week 3 and 1 year
Overall survival	Will use the Kaplan-Meier method to estimate overall survival throughout three years from the time of completing treatment.	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

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Gita Suneja, MD, Huntsman Cancer Institute/ University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2021
• Primary Completion (Estimated): November 15, 2025
• Study Completion (Estimated): November 15, 2027

Study Registration Dates

• First Submitted: November 18, 2021
• First Submitted That Met QC Criteria: November 18, 2021
• First Posted (Actual): December 1, 2021

Study Record Updates

• Last Update Posted (Estimated): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Carcinoma; Endometrial Neoplasms
• Other Study ID Numbers: HCI144462 (Other Identifier: Huntsman Cancer Institute/University of Utah); P30CA042014 (U.S. NIH Grant/Contract); NCI-2021-12258 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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