Metastatic Malignant Female Reproductive System NeoplasmPhase 2NCT04516135
Single Fraction or Multi-fraction Palliative Radiation Therapy for the Improvement of Quality of Life in Patients With Metastatic Gynecologic Cancers
A Phase 2 study testing 3-Dimensional Conformal Radiation Therapy, Intensity-Modulated Radiation Therapy and Quality-of-Life Assessment in people with Metastatic Malignant Female Reproductive System Neoplasm, run by M.D. Anderson Cancer Center at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Malignant Female Reproductive System Neoplasm
- What is being tested?
- 3-Dimensional Conformal Radiation Therapy, Intensity-Modulated Radiation Therapy and Quality-of-Life Assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Jan 2021to 31 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cooper Hospital University
Camden, New Jersey, 08103
OhioHealth
Columbus, Ohio, 43215
M D Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Randomized Phase II Trial of Palliative Pelvic Radiation Therapy to Improve Health Related Quality of Life in Gynecologic Malignancies
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine whether single fraction palliative radiation therapy (SFRT) improves the proportion of patients with improved Health-Related Quality of Life (HR-QOL) over multi-fraction palliative radiotherapy (MFRT).
SECONDARY OBJECTIVES:
- To determine whether single fraction palliative radiation therapy (SFRT) improves overall health related quality of life (HR-QOL) over multi fraction palliative radiation therapy (MFRT).
II. To determine whether SFRT improves individual domains of HR-QOL over MFRT.
III. To determine whether SFRT increases clinically meaningful HR-QOL improvement over MFRT.
IV. To determine whether SFRT provides non-inferior symptom burden improvement (SBI) to MFRT.
EXPLORATORY OBJECTIVES:
- 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.
- To describe financial burden of patients undergoing palliative pelvic radiation with SFRT and 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.
- Being tested
- 3-Dimensional Conformal Radiation Therapy, Intensity-Modulated Radiation Therapy, Quality-of-Life Assessment, Questionnaire Administration, Volume Modulated Arc Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-Dimensional Conformal Radiation TherapyRadiation
Also called 3-dimensional radiation therapy, 3D CONFORMAL RADIATION THERAPY, 3D CRT, 3D-CRT
Undergo 3D CRT
Intensity-Modulated Radiation TherapyRadiation
Also called IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy, Radiation, Intensity-Modulated Radiotherapy
Undergo IMRT
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Volume Modulated Arc TherapyRadiation
Also called VMAT
Undergo VMAT
| Study group | Role | What they receive |
|---|---|---|
| Arm A (radiation therapy) | Experimental | Patients undergo standard of care radiation therapy in the form of 3D CRT, IMRT, or VMAT at the physician's discretion for 1 fraction in the absence of disease progression or unacceptable toxicity. Patients with < 30% decrease in the SIS may receive an additional fraction on day 21 at the physician's discretion. Receives: Radiation: 3-Dimensional Conformal Radiation Therapy; Radiation: Intensity-Modulated Radiation Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Volume Modulated Arc Therapy |
| Arm B (radiation therapy) | Active comparator | 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. Receives: Radiation: 3-Dimensional Conformal Radiation Therapy; Radiation: Intensity-Modulated Radiation Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Volume Modulated Arc Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in index value of EuroQol 5 Dimensions - 5 Levels (EQ-5D-5L) score
An index value will be calculated for each participant according to page 13 of the user guide. Scores will be summarized using descriptive statistics. Will use a 2-sample t-test to compare the change scores between the single fraction palliative radiation therapy (SFRT) and multi-fraction palliative radiation therapy (MFRT) groups.
Measured: Baseline up to 21 days post-radiation therapy
Secondary outcomes (8)
Absolute change in mobility
Each dimension is rated on a scale from 1 to 5 where 1 represents no problem present or patient can care for self and 5 represents extreme problems present or unable to care for self. Improvement within each dimension will be assessed by the absolute change of heath state. A decrease in the raw score by 1 or more points denotes improvement within the dimension.
Measured: Baseline up to 21 days post-radiation therapy
Absolute change in self-care
Each dimension is rated on a scale from 1 to 5 where 1 represents no problem present or patient can care for self and 5 represents extreme problems present or unable to care for self. Improvement within each dimension will be assessed by the absolute change of heath state. A decrease in the raw score by 1 or more points denotes improvement within the dimension.
Measured: Baseline up to 21 days post-radiation therapy
Absolute change in activity
Each dimension is rated on a scale from 1 to 5 where 1 represents no problem present or patient can care for self and 5 represents extreme problems present or unable to care for self. Improvement within each dimension will be assessed by the absolute change of heath state. A decrease in the raw score by 1 or more points denotes improvement within the dimension.
Measured: Baseline up to 21 days post-radiation therapy
Absolute change in pain
Each dimension is rated on a scale from 1 to 5 where 1 represents no problem present or patient can care for self and 5 represents extreme problems present or unable to care for self. Improvement within each dimension will be assessed by the absolute change of heath state. A decrease in the raw score by 1 or more points denotes improvement within the dimension.
Measured: Baseline up to 21 days post-radiation therapy
Absolute change in anxiety
Each dimension is rated on a scale from 1 to 5 where 1 represents no problem present or patient can care for self and 5 represents extreme problems present or unable to care for self. Improvement within each dimension will be assessed by the absolute change of heath state. A decrease in the raw score by 1 or more points denotes improvement within the dimension.
Measured: Baseline up to 21 days post-radiation therapy
>= 6 point increase in EuroQol-Visual Analogue Scale
Will summarize the number of patients with clinical meaningful health-related (HR)-quality of life (QOL) improvement using frequencies and proportions. The proportion of patients with clinically meaningful HR-QOL improvement will be compared between SFRT and MFRT using a chi-squared test.
Measured: Baseline up to 21 days post-radiation therapy
Decrease in Symptom Inventory (SIS)
Will be calculated as the average of the worst pain, least pain, pain on average, pain right now and scores from the vaginal bleeding questions. The change in SIS score from baseline to 21 days post radiation therapy will be calculated for each patient and evaluated between the SFRT and MFRT groups using a t-test. Will be calculated as the average of the worst pain, least pain, pain on average, pain right now and scores from the vaginal bleeding questions. The change in SIS score from baseline to 21 days post radiation therapy will be calculated for each patient and evaluated between the SFRT and MFRT groups using a t-test.
Measured: At 21 days post-radiation therapy
Incidence of adverse events
Assessed per Common Terminology Criteria for Adverse Events version 5.0. Radiation related toxicity event rates within 21 days and within one year for patients receiving SFRT and MFRT will be summarized using frequencies and proportions. Proportions between SFRT and MFRT will be compared using a chi-squared or Fisher's exact test.
Measured: Within 21 days and up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start11 Jan 2021
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Malignant Female Reproductive System NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lauren Colbert, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516135
- Sponsor's protocol ID
- 2020-0517
- Other IDs
- NCI-2020-05684, 2020-0517
- Status last verified
- Oct 2026
- First submitted
- 13 Aug 2020
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial of Palliative Pelvic Radiation Therapy to Improve Health Related Quality of Life in Gynecologic Malignancies
- ClinicalTrials.gov ID
- NCT04516135
- Acronym / sponsor ID
- 2020-0517
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 18 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine whether single fraction palliative radiation therapy (SFRT) improves the proportion of patients with improved Health-Related Quality of Life (HR-QOL) over multi-fraction palliative radiotherapy (MFRT).
SECONDARY OBJECTIVES:
- To determine whether single fraction palliative radiation therapy (SFRT) improves overall health related quality of life (HR-QOL) over multi fraction palliative radiation therapy (MFRT).
II. To determine whether SFRT improves individual domains of HR-QOL over MFRT.
III. To determine whether SFRT increases clinically meaningful HR-QOL improvement over MFRT.
IV. To determine whether SFRT provides non-inferior symptom burden improvement (SBI) to MFRT.
EXPLORATORY OBJECTIVES:
- 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.
- To describe financial burden of patients undergoing palliative pelvic radiation with SFRT and 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (radiation therapy) | Experimental | Radiation: 3-Dimensional Conformal Radiation Therapy, Radiation: Intensity-Modulated Radiation Therapy, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Radiation: Volume Modulated Arc TherapyPatients undergo standard of care radiation therapy in the form of 3D CRT, IMRT, or VMAT at the physician's discretion for 1 fraction in the absence of disease progression or unacceptable toxicity. Patients with < 30% decrease in the SIS may receive an additional fraction on day 21 at the physician's discretion. |
| Arm B (radiation therapy) | Active comparator | Radiation: 3-Dimensional Conformal Radiation Therapy, Radiation: Intensity-Modulated Radiation Therapy, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Radiation: Volume Modulated Arc TherapyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3-Dimensional Conformal Radiation TherapyAlso: 3-dimensional radiation therapy, 3D CONFORMAL RADIATION THERAPY, 3D CRT, 3D-CRTUndergo 3D CRT | Radiation | Arm A (radiation therapy), Arm B (radiation therapy) |
| Intensity-Modulated Radiation TherapyAlso: IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy, Radiation, Intensity-Modulated RadiotherapyUndergo IMRT | Radiation | Arm A (radiation therapy), Arm B (radiation therapy) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm A (radiation therapy), Arm B (radiation therapy) |
| Questionnaire AdministrationAncillary studies | Other | Arm A (radiation therapy), Arm B (radiation therapy) |
| Volume Modulated Arc TherapyAlso: VMATUndergo VMAT | Radiation | Arm A (radiation therapy), Arm B (radiation therapy) |
Primary outcome
Absolute change in index value of EuroQol 5 Dimensions - 5 Levels (EQ-5D-5L) score
Time frame: Baseline up to 21 days post-radiation therapy
An index value will be calculated for each participant according to page 13 of the user guide. Scores will be summarized using descriptive statistics. Will use a 2-sample t-test to compare the change scores between the single fraction palliative radiation therapy (SFRT) and multi-fraction palliative radiation therapy (MFRT) groups.
8 secondary outcomes
Absolute change in mobility
Time frame: Baseline up to 21 days post-radiation therapy
Absolute change in self-care
Time frame: Baseline up to 21 days post-radiation therapy
Absolute change in activity
Time frame: Baseline up to 21 days post-radiation therapy
Absolute change in pain
Time frame: Baseline up to 21 days post-radiation therapy
Absolute change in anxiety
Time frame: Baseline up to 21 days post-radiation therapy
>= 6 point increase in EuroQol-Visual Analogue Scale
Time frame: Baseline up to 21 days post-radiation therapy
Decrease in Symptom Inventory (SIS)
Time frame: At 21 days post-radiation therapy
Incidence of adverse events
Time frame: Within 21 days and up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
Related trials for Metastatic Malignant Female Reproductive System Neoplasm
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Active, not recruitingPhase 2
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
RecruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren Colbert principal investigator
M.D. Anderson Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 3-Dimensional Conformal Radiation Therapy, Intensity-Modulated Radiation Therapy and Quality-of-Life Assessment in people with Metastatic Malignant Female Reproductive System Neoplasm, run by M.D. Anderson Cancer Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change in index value of EuroQol 5 Dimensions - 5 Levels (EQ-5D-5L) score (time frame: Baseline up to 21 days post-radiation therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.