Clinical trial NCT05139368: Hypofractionated Radiotherapy for the Treatment of Cervical or Endometrial Cancer
Official title: RT-PACE: A Pilot Study of Adjuvant Hypo-Fractionated Radiotherapy for Non-Metastatic Cervical and Endometrial Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cervical Carcinoma
Endometrial Carcinoma
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-12-01
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in toxicity
timeFrame: Baseline to week 3 of pelvic radiotherapy
measure: Ability to administer clinical trial to evaluate hypofractionated radiotherapy
timeFrame: Up to 3 years
Secondary outcomes:
measure: Change in urinary domain of the Expanded Prostate Cancer Index Composite (EPIC) instrument
timeFrame: Baseline to week 3 and 1 year
measure: Change in gastrointestinal toxicities as collected through Patient-Reported Outcomes instruments (PRO-CTCAE)
timeFrame: Baseline to week 3 and 1 year
measure: Change in Functional Assessment of Cancer Therapy-Cervix (FACT-Cx)
timeFrame: Baseline to week 3 and 1 year
measure: Change in COST-FACIT Measure of Financial Toxicity
timeFrame: Baseline to week 3 and 1 year
measure: Decision Regret Scale- summary score
timeFrame: At week 3 and 1 year
measure: Overall survival
timeFrame: 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
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute/University of Utah
state: Utah
Study officials:
affiliation: Huntsman Cancer Institute/ University of Utah
name: Gita Suneja, MD
role: PRINCIPAL_INVESTIGATOR
References: