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Palliative radiation therapy for Cancer

N/A
Recruiting
Led By Shivani Sud, MD
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Written informed consent was obtained to participate in the study and HIPAA
Authorization for release of personal health information. Ability to understand and willingness to sign informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 month, 3 months, 6 months, 9 months, and 12 months
Awards & highlights

Summary

The purpose of this registry is to collect clinical data from participants attending UNC Hospitals who present with metastatic cancer and are evaluated to receive radiation therapy as part of their standard of care treatment. The goal of this study is to provide a foundation for studies designed to identify projects across the translational continuum related to metastatic cancer and radiation therapy treatment. The relevant clinical data will be linked to patient-reported outcomes (PROs) thus allowing for a unique and robust dataset. Ultimately, this registry will provide current and future studies with the ability to analyze the correlation of radiation therapy regimens with metastatic cancer outcomes.

Eligible Conditions
  • Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 month, 3 months, 6 months, 9 months, and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 month, 3 months, 6 months, 9 months, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical Data
Secondary outcome measures
Patient reported outcomes (PRO)

Side effects data

From 2013 Phase 3 trial • 397 Patients • NCT00004054
78%
Menopausal symptoms
60%
Urinary frequency
52%
Impotence
47%
Late RT Toxicity: Bladder: NOS
39%
Diarrhea NOS
27%
Late RT Toxicity: Bowel: NOS
26%
Fatigue
26%
Late RT Toxicity: Other GU: NOS
21%
Proctitis NOS
21%
Dysuria
14%
Libido decreased
14%
Dermatitis radiation NOS
12%
Late RT Toxicity: Other GI: NOS
12%
Late RT Toxicity: Other: NOS
12%
Hemoglobin decreased
12%
Alanine aminotransferase increased
9%
Gynaecomastia
8%
Urinary retention
7%
Pain-other
7%
Aspartate aminotransferase increased
6%
Rectal bleeding
6%
Constipation
6%
Leukopenia NOS
4%
Edema NOS
4%
Hematuria present
4%
Renal/GU-Other
3%
Arthralgia
3%
Blood creatinine increased
3%
Dyspnea NOS
3%
Dermatitis exfoliative NOS
2%
Nausea
2%
Hyperglycemia NOS
2%
Depression NEC
2%
Lymphopenia
2%
Myalgia
2%
Peripheral sensory neuropathy
1%
Platelet count decreased
1%
Stomatitis
1%
Blood albumin decreased
1%
Weight decreased
1%
Anorexia
1%
Hypocalcemia
1%
Hyponatremia
1%
Hematologic-Other
1%
Neutropenia
1%
Alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Hormones and RT
Hormones and RT Plus Chemotherapy

Trial Design

1Treatment groups
Experimental Treatment
Group I: Palliative radiation therapyExperimental Treatment1 Intervention
Subjects who are with metastatic cancer receive palliative radiation therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation therapy
2013
Completed Phase 3
~2850

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor
354 Previous Clinical Trials
89,458 Total Patients Enrolled
Shivani Sud, MDPrincipal InvestigatorUNC Lineberger Comprehensive Cancer Center
3 Previous Clinical Trials
297 Total Patients Enrolled
~1333 spots leftby May 2033