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Brachytherapy

MRI-Guided Internal Radiation for Cervical and Vaginal Cancer

Phase 1
Recruiting
Led By Ann H Klopp
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
Women with stage 1B2-IVA cervical cancer recommended to receive definitive chemoradiation including brachytherapy
Women with stage II-IVA vaginal cancer recommended to receive definitive chemoradiation including brachytherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

Study Summary

This trial uses MRI-guided brachytherapy to treat cervical or vaginal cancer in patients with HPV. MRI guidance during brachytherapy applicator placement may improve treatment planning.

Who is the study for?
This trial is for women with stage IB2-IVA cervical cancer or stage II-IVA vaginal cancer, recommended to receive chemoradiation including brachytherapy. It's not suitable for those with non-MRI-compatible anatomy, pacemakers, defibrillators, or conditions that prevent MRI use.Check my eligibility
What is being tested?
The study tests if using MRI guidance to place the internal radiation therapy device (brachytherapy) can improve treatment planning and outcomes in participants with HPV-associated cervical or vaginal cancers.See study design
What are the potential side effects?
Potential side effects of MRI-guided brachytherapy may include discomfort at the applicator site, localized tissue damage, fatigue from radiation exposure, and possible short-term changes in bowel and bladder habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Women with advanced stage cervical cancer who are recommended to receive a specific type of treatment called chemoradiation, including brachytherapy.
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Women with a specific stage of vaginal cancer who are advised to undergo a specific type of treatment involving chemotherapy and radiation therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent of patients achieving high-risk clinical target volume (HR-CTV) dose to 90% (D90)
Secondary outcome measures
Biomarker measurements (tumor viability and tumor T cell profile) from tumor samples
Cost difference associated with the MRI-guided versus the standard process
Diffusion weighted imaging (DWI) outcomes
+4 more

Side effects data

From 2016 Phase 2 trial • 60 Patients • NCT00369122
69%
White blood cell decreased
58%
Fatigue
54%
Anemia
54%
Nausea
51%
Diarrhea
44%
Platelet count decreased
42%
Vaginal hemorrhage
39%
Hypomagnesemia
29%
Constipation
29%
Lymphocyte count decreased
29%
Neutrophil count decreased
29%
Hyperglycemia
29%
Hypokalemia
27%
Hyponatremia
25%
Vomiting
24%
Hot flashes
22%
Hypoalbuminemia
20%
Headache
19%
Pelvic pain
19%
Vaginal discharge
19%
Hypocalcemia
19%
Abdominal pain
19%
Anorexia
14%
Depression
14%
Anxiety
14%
Insomnia
14%
Weight loss
14%
Urinary frequency
14%
Alanine aminotransferase increased
12%
Hypercalcemia
10%
Vaginal obstruction
10%
Dermatitis radiation
10%
Hypertension
10%
Back pain
8%
Rectal pain
8%
Peripheral sensory neuropathy
8%
Voice alteration
8%
Creatinine increased
8%
Hypotension
8%
Dysgeusia
8%
Vaginal inflammation
8%
Arthralgia
8%
Dizziness
8%
Rash maculo-papular
8%
Rectal hemorrhage
8%
Alkaline phosphatase increased
8%
Aspartate aminotransferase increased
8%
Cystitis noninfective
8%
Dyspnea
7%
Chills
7%
Edema limbs
7%
Dyspepsia
7%
Infections and infestations - Other
7%
Tinnitus
7%
Vaginal pain
7%
Fever
7%
Pain
7%
Urinary tract pain
7%
Irregular menstruation
7%
Proctitis
5%
Investigations - Other
5%
Urinary tract infection
5%
Dehydration
5%
Perineal pain
5%
Nervous system disorders - Other
5%
Weight gain
5%
Vaginal infection
5%
Renal and urinary disorders - Other
5%
Urinary incontinence
5%
Hemorrhoids
5%
Cough
5%
Epistaxis
3%
Hyperuricemia
3%
Hyperhidrosis
3%
Uterine pain
3%
Dry skin
3%
Skin induration
3%
Telangiectasia
3%
Skin and subcutaneous tissue disorders - Other
3%
Acidosis
3%
Hyperkalemia
3%
Hypoglycemia
3%
Hypophosphatemia
3%
Myalgia
3%
Hemoglobinuria
3%
Pruritus
3%
Vascular disorders - Other
3%
Dysphagia
3%
Gastrointestinal disorders - Other
3%
Mucositis oral
3%
Activated partial thromboplastin time prolonged
3%
Alopecia
2%
Peripheral motor neuropathy
2%
Vaginal dryness
2%
Colitis
2%
Sinusitis
2%
Uterine obstruction
2%
Vaginal fistula
2%
Flashing lights
2%
Uterine hemorrhage
2%
Thromboembolic event
2%
Hearing impaired
2%
Bladder infection
2%
Catheter related infection
2%
Vascular access complication
2%
Anal fistula
2%
Skin ulceration
2%
Ureteric anastomotic leak
2%
Neck pain
2%
Anal pain
2%
Pain in extremity
2%
Agitation
2%
Skin hypopigmentation
2%
Cholesterol high
2%
Extraocular muscle paresis
2%
Lung infection
2%
Allergic reaction
2%
Lactation disorder
2%
GGT increased
2%
Abdominal distension
2%
Facial nerve disorder
2%
Reproductive system and breast disorders - Other
2%
Blurred vision
2%
Dry mouth
2%
Soft tissue infection
2%
Flushing
2%
Febrile neutropenia
2%
Syncope
2%
Urinary tract obstruction
2%
Bronchopulmonary hemorrhage
2%
General disorders and administration site conditions - Other
2%
Non-cardiac chest pain
2%
Hypernatremia
2%
Bone pain
2%
Joint range of motion decreased
2%
Musculoskeletal and connective tissue disorder - Other
2%
Bladder spasm
2%
Proteinuria
2%
Urinary retention
2%
Rash acneiform
2%
Esophagitis
2%
Gastritis
2%
Blood bilirubin increased
2%
Chronic kidney disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Radiation Therapy, Bevacizumab, Cisplatin)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (MRI, internal radiation therapy)Experimental Treatment2 Interventions
Participants undergo MRI scan during internal radiation therapy applicator placement.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1310
Internal Radiation Therapy
2006
Completed Phase 3
~290

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,586 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,389 Total Patients Enrolled
Ann H KloppPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
22 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies for volunteers in this experiment?

"Affirmative. According to the clinicaltrials.gov information, this research project is still recruiting participants; it was first announced on August 3rd 2018 and modified most recently on September 22nd 2022. There are 60 spots open at a solitary medical centre."

Answered by AI

Could you provide a figure for the current participant count in this trial?

"Confirmed. The records kept on clinicaltrials.gov indicate that this medical trial is currently seeking volunteers, after the initial posting date of August 3rd 2018 and most recent update made on September 22nd 2022. 60 individuals from one location are required for enrollment into this study."

Answered by AI

What safety measures should be taken when administering Internal Radiation Therapy to patients?

"With limited data present on Internal Radiation Therapy's efficacy and safety, this medical trial was assigned a score of 1."

Answered by AI
~9 spots leftby Mar 2025