Clinical trial NCT04516135: Single Fraction or Multi-fraction Palliative Radiation Therapy for the Improvement of Quality of Life in Patients With Metastatic Gynecologic Cancers
Official title: A Randomized Phase II Trial of Palliative Pelvic Radiation Therapy to Improve Health Related Quality of Life in Gynecologic Malignancies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Metastatic Malignant Female Reproductive System Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-08-18
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This phase II trial studies if a single session of palliative radiation therapy can help improve symptoms of gynecologic cancers that have spread to other places in the body (metastatic) and that affect quality of life as well or more so than multiple sessions (which is the standard of care). Palliative radiation therapy may help patients with metastatic gynecologic cancers live more comfortably. Researchers also want to learn how radiation affects the immune system and to compare the effects of giving one radiation treatment to giving multiple radiation treatments.

Detailed description: PRIMARY OBJECTIVE:

I. To determine whether single fraction palliative radiation therapy (SFRT) improves health-related quality of life (HR-QOL) over multi-fraction palliative radiotherapy (MFRT).

SECONDARY OBJECTIVES:

I. To determine whether single fraction palliative radiation therapy (SFRT) improves individual domains of health-related quality of life (HR-QOL) over multi-fraction palliative radiotherapy (MFRT).

II. To determine whether SFRT increases clinically meaningful HR-QOL improvement over MFRT.

III. To determine whether SFRT provides non-inferior symptom burden improvement to MFRT.

IV. To describe radiation related toxicity rates within 21 days and within year for patients receiving SFRT and MFRT.

EXPLORATORY OBJECTIVES:

I. To describe T-cell repertoire of patients receiving SFRT and MFRT. II. To describe vaginal microbiome of patients receiving SFRT and MFRT. III. To describe gut microbiome of patients receiving SFRT and MFRT. IV. To describe financial burden of patients undergoing palliative pelvic radiation with either SFRT or MFRT.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients undergo standard of care radiation therapy in the form of 3-dimensional conformal radiation therapy (3D CRT), intensity-modulated radiation therapy (IMRT), or volume modulated arc therapy (VMAT) at the physician's discretion for 1 fraction in the absence of disease progression or unacceptable toxicity. Patients with \< 30% decrease in the Symptom Inventory Scale (SIS) may receive an additional fraction on day 21 at the physician's discretion.

ARM B: Patients undergo standard of care radiation therapy in the form of 3D CRT, IMRT, or VMAT at the physician's discretion over 2 weeks for 10 fractions in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for up to 1 year.

Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically documented gynecologic cancer with prior or current evidence of metastatic disease
* Measurable pelvic disease with any pain and/or bleeding
* Eastern Cooperative Oncology Group (ECOG) performance status of =\< 3
* Estimated life expectancy \> 3 months at discretion of treating physician
* Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication
* Patient able to provide properly obtained written informed consent
* Gynecologic Section Radiation Oncology Quality Assurance (QA) for eligibility for single fraction radiation treatment

Exclusion Criteria:

* Prior pelvic radiation therapy that would make treatment unsafe at the discretion of the treating physician
* Systemic therapy concurrently or within 21 days of first dose of radiation
* Concurrent participation in another interventional radiation therapy trial concurrently or within 30 days of study consent. Note: Patients who are participating in systemic clinical trials and non-interventional clinical trials (e.g., QOL, imaging, observational, follow-up studies, etc.) are eligible, regardless of the timing of participation
* Known second malignancy that requires active treatment (at the discretion of the primary investigator)
* Documented psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
* Pregnant or breastfeeding at any point starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment

Primary outcomes:
measure: Absolute change in index value of EuroQol 5 Dimensions - 5 Levels (EQ-5D-5L) score
timeFrame: Baseline up to 21 days post-radiation therapy
Secondary outcomes:
measure: Absolute change in mobility
timeFrame: Baseline up to 21 days post-radiation therapy
measure: Absolute change in self-care
timeFrame: Baseline up to 21 days post-radiation therapy
measure: Absolute change in activity
timeFrame: Baseline up to 21 days post-radiation therapy
measure: Absolute change in pain
timeFrame: Baseline up to 21 days post-radiation therapy
measure: Absolute change in anxiety
timeFrame: Baseline up to 21 days post-radiation therapy
measure: >= 6 point increase in EuroQol-Visual Analogue Scale
timeFrame: Baseline up to 21 days post-radiation therapy
measure: Decrease in Symptom Inventory (SIS)
timeFrame: At 21 days post-radiation therapy
measure: Incidence of adverse events
timeFrame: Within 21 days and up to 1 year
Other outcomes:
measure: T-cell repertoire
timeFrame: Up to 1 year
measure: Vaginal microbiome
timeFrame: Up to 1 year
measure: Gut microbiome
timeFrame: Up to 1 year
measure: Financial burden
timeFrame: Up to 21 days
Locations:
city: Camden
country: United States
facility: Cooper Hospital University
state: New Jersey
city: Columbus
country: United States
facility: OhioHealth
state: Ohio
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Lauren Colbert
role: PRINCIPAL_INVESTIGATOR
References: