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Radiation Therapy
Palliative Radiation Therapy for Malignant Female Reproductive System Cancer
Phase 2
Recruiting
Led By Lauren Colbert
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically documented gynecologic cancer with prior or current evidence of metastatic disease
Measurable pelvic disease with any pain and/or bleeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial studies if one radiation treatment can improve symptoms of metastatic gynecologic cancers and help patients live more comfortably. It also looks at the effects of one vs multiple treatments.
Who is the study for?
This trial is for women with metastatic gynecologic cancers experiencing pain or bleeding. Participants must have a life expectancy over 3 months, be able to consent, and use contraception if of childbearing potential. Exclusions include prior pelvic radiation, active participation in other interventional radiation trials within 30 days, psychiatric disorders affecting trial compliance, pregnancy or breastfeeding through 120 days post-treatment.Check my eligibility
What is being tested?
The study compares single-session palliative radiation therapy's effectiveness against multiple sessions (standard care) for symptom relief in metastatic gynecologic cancer patients. It also examines the impact on the immune system and quality of life using various advanced radiation techniques.See study design
What are the potential side effects?
Potential side effects from the radiation therapy may include skin irritation at the treatment site, fatigue, mild swelling or discomfort in treated areas. Long-term risks can involve changes to bowel or bladder habits and rare cases of secondary cancers.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My gynecologic cancer has spread, confirmed by tests.
Select...
I have pelvic disease causing pain or bleeding that can be measured.
Select...
I can take care of myself but may not be able to do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Absolute change in index value of EuroQol 5 Dimensions - 5 Levels (EQ-5D-5L) score
Secondary outcome measures
>= 6 point increase in EuroQol-Visual Analogue Scale
Absolute change in activity
Anxiety
+5 moreOther outcome measures
Financial burden
Gut microbiome
T-cell repertoire
+1 moreSide effects data
From 2022 Phase 3 trial • 87 Patients • NCT0206618173%
Fatigue
71%
Palmar-plantar erythrodysesthesia syndrome
63%
Hypertension
61%
Papulopustular rash
55%
Diarrhea
51%
Nausea
39%
Myalgia
37%
Alopecia
35%
Arthralgia
33%
Abdominal pain
31%
Anorexia
27%
Vomiting
22%
Mucositis oral
22%
Constipation
18%
Anemia
18%
Alanine aminotransferase increased
16%
Platelet count decreased
14%
Pruritus
14%
Hyperglycemia
14%
Rash maculo-papular
14%
Skin and subcutaneous tissue disorders - Other, specify
12%
Aspartate aminotransferase increased
12%
Rash acneiform
12%
Peripheral sensory neuropathy
10%
Investigations - Other, specify
10%
Dry skin
10%
Neutrophil count decreased
10%
Blood bilirubin increased
8%
Back pain
8%
Headache
8%
Nervous system disorders - Other, specify
8%
Pain in extremity
6%
General disorders and administration site conditions - Other, specify
6%
Skin infection
6%
White blood cell decreased
6%
Hypercalcemia
6%
Hypokalemia
6%
Musculoskeletal and connective tissue disorder - Other, specify
6%
Dizziness
6%
Respiratory, thoracic and mediastinal disorders - Other, specify
6%
Eye disorders - Other, specify
6%
Hyperkalemia
6%
Pain
6%
Alkaline phosphatase increased
6%
Hypocalcemia
6%
Cough
4%
Flushing
4%
Tinnitus
4%
Dental caries
4%
Gastrointestinal disorders - Other, specify
4%
Hemoglobin increased
4%
Weight loss
4%
Metabolism and nutrition disorders - Other, specify
4%
Dysgeusia
4%
Anxiety
4%
Irregular menstruation
4%
Menorrhagia
4%
Sore throat
4%
Lymphocyte count decreased
4%
Hyperuricemia
4%
Non-cardiac chest pain
4%
Infections and infestations - Other, specify
4%
Hypernatremia
4%
Hypoglycemia
4%
Scalp pain
4%
Dry mouth
2%
Acute kidney injury
2%
Blurred vision
2%
Hemorrhoids
2%
Hypothyroidism
2%
Urticaria
2%
Palpitations
2%
Leukocytosis
2%
Myocardial infarction
2%
Vertigo
2%
Anal hemorrhage
2%
Dysphagia
2%
Esophageal pain
2%
Periodontal disease
2%
Fever
2%
Sinusitis
2%
Urinary tract infection
2%
Bruising
2%
Dermatitis radiation
2%
Cholesterol high
2%
Creatinine increased
2%
Neck pain
2%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
2%
Concentration impairment
2%
Memory impairment
2%
Spasticity
2%
Depression
2%
Insomnia
2%
Allergic rhinitis
2%
Productive cough
2%
Sleep apnea
2%
Pregnancy, puerperium and perinatal conditions - Other, specify
2%
Dry eye
2%
Lymphedema
2%
Chest pain - cardiac
2%
Heart failure
2%
Gastric perforation
2%
Hypertriglyceridemia
2%
Dyspnea
2%
Cardiac disorders - Other, specify
2%
Gastroesophageal reflux disease
2%
Oral dysesthesia
2%
Chills
2%
Hypophosphatemia
2%
Chest wall pain
2%
Psychiatric disorders - Other, specify
2%
Hematuria
2%
Urinary tract obstruction
2%
Dysmenorrhea
2%
Skin hypopigmentation
2%
Unintended pregnancy
2%
Flu like symptoms
2%
Nail infection
2%
Pancreatitis
2%
Blood and lymphatic system disorders - Other, specify
2%
Oral pain
2%
Fall
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Sorafenib Tosylate)
Arm II (Placebo)
Crossover Group
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (radiation therapy)Experimental Treatment5 Interventions
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.
Group II: Arm B (radiation therapy)Active Control5 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Volume Modulated Arc Therapy
2017
Completed Early Phase 1
~30
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
3-Dimensional Conformal Radiation Therapy
2010
Completed Phase 3
~7230
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,666 Previous Clinical Trials
40,925,897 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,238 Total Patients Enrolled
Lauren ColbertPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have another cancer that needs treatment, as decided by my doctor.I haven't had systemic therapy in the last 21 days before my first radiation dose.My gynecologic cancer has spread, confirmed by tests.My doctor thinks previous radiation in my pelvis makes treatment risky.I have pelvic disease causing pain or bleeding that can be measured.I can take care of myself but may not be able to do heavy physical work.I agree to use birth control during and up to 120 days after the study.My treatment plan has passed quality checks for a one-time radiation dose.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (radiation therapy)
- Group 2: Arm A (radiation therapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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