Quality-of-Life Assessment for Fallopian Tube Carcinoma
Sutter Cancer Centers Radiation Oncology Services-Vacaville, Vacaville, CA
Targeting 33 different conditionsQuality-of-Life Assessment +7 morePhase 3Waitlist AvailableLed by David AlbertsResearch Sponsored by Gynecologic Oncology GroupEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to 9 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Study Summary
This trial is testing whether changes in diet and physical activity can help patients with ovarian, fallopian tube, or primary peritoneal cancer live longer without their cancer returning.
Eligible Conditions
- Fallopian Tube Carcinoma
- Ovarian Cancer
- Fallopian Tube Cancer
- Endometrioid Adenocarcinoma
- Fallopian Tube Adenocarcinoma
- Ovarian Carcinoma
- Ovarian Adenocarcinoma
- Peritoneal Serous Adenocarcinoma
- Peritoneal Cancer
- Ovarian Brenner Tumor
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 9 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 9 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival
Secondary outcome measures
Change in irritable bowel syndrome-specific symptoms measured using GSRS-IBS
Change in self-reported quality of life measured using RAND-36
Other outcome measures
Change in sleep quality measured using Pittsburgh Sleep Quality Index
Change in telomere length
Changes in visceral adiposity using CT scan
+7 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%
Constipation
22%
Mucositis oral
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%
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%
Flushing
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%
Palpitations
2%
Acute kidney injury
2%
Leukocytosis
2%
Myocardial infarction
2%
Vertigo
2%
Hypothyroidism
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%
Hemorrhoids
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%
Urticaria
2%
Unintended pregnancy
2%
Flu like symptoms
2%
Nail infection
2%
Pancreatitis
2%
Blood and lymphatic system disorders - Other, specify
2%
Blurred vision
2%
Oral pain
2%
Fall
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Sorafenib Tosylate)
Arm II (Placebo)
Crossover Group
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group I (lifestyle intervention)Experimental Treatment8 Interventions
Participants receive a dietary intervention designed to promote increased levels of plasma carotenoids, control weight, and to ensure adequacy of micronutrient intake. Participants also undergo a physical activity intervention comprising a moderately low aerobic regimen to raise the usual activity level. Participants also undergo face-to-face counseling, receive educational materials and counseling focused on how to read food labels to estimate grams of fat per serving and serving size, and undergo telephone counseling by a lifestyle intervention counselor twice a week for 4 weeks, then weekly for 2 weeks, twice a month for 5 months, monthly for the subsequent 6 months, and then once every other month for 12 months. Participants complete daily fat gram and step diaries at least three times per week.
Group II: Group II (observation)Active Control3 Interventions
Participants receive a study notebook containing general study-related information. Participants are not asked to record diet or physical activity but are provided a single sample diary in their study notebook. Participants receive telephone contact on a sliding scale similar to the intervention group, but at less frequent intervals (22 versus 33 calls over the course of the intervention).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Behavioral Dietary Intervention
2016
N/A
~70
Compliance Monitoring
2005
N/A
~840
Exercise Intervention
2017
Completed Phase 4
~1810
Find a site
Who is running the clinical trial?
Gynecologic Oncology GroupLead Sponsor
250 Previous Clinical Trials
69,853 Total Patients Enrolled
12 Trials studying Fallopian Tube Carcinoma
5,260 Patients Enrolled for Fallopian Tube Carcinoma
National Cancer Institute (NCI)NIH
13,402 Previous Clinical Trials
41,224,271 Total Patients Enrolled
21 Trials studying Fallopian Tube Carcinoma
6,393 Patients Enrolled for Fallopian Tube Carcinoma
David AlbertsPrincipal Investigator
NRG Oncology2 Previous Clinical Trials
77 Total Patients Enrolled
Media Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How risky is Quality-of-Life Assessment for patients?
"There is some efficacy data as well as multiple rounds of safety data, so our team gave Quality-of-Life Assessment a 3."
Answered by AI
In how many different medical clinics is this research study being conducted currently?
"There are 100 patients enrolling at clinical trial sites such as Sanford Broadway Medical Center in Fargo, Riverside Methodist Hospital in Columbus, and Sanford Cancer Center Oncology Clinic in Sioux Falls."
Answered by AI
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