Hypofractionated Radiotherapy for Soft Tissue Sarcoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Soft Tissue SarcomaHypofractionated Radiotherapy - Radiation
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial uses a shorter, more intense course of radiation to treat soft tissue sarcomas. The hope is that it will allow patients to be treated more quickly with similar rates of controlling the cancer.

Eligible Conditions
  • Soft Tissue Sarcoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Approximately 2 years

Approximately 2 years
Local control rate
Measure of late functional side effects
Measure of late skin side effects
Measure of late subcutaneous side effects
Post- Operative Complication rate
Approximately 90 days
Measurement of acute dermatitis

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Erlotinib and Radiotherapy
71%Rash
53%Death
41%Fatigue
41%Diarrhea
35%Bilirubin Increased
29%Nausea
24%Elevated Hemoglobin
18%Pain
18%Esophagitis
18%Dry skin
18%Glucose, serum-high
18%Dyspnea
18%Creatinine increased
12%Hypokalemia
12%Pneumonitis
12%Sodium, serum-low
12%Lymphopenia
12%Constipation
12%Dermatitis
12%Dysphagia
12%Dry eye
12%Myositis
12%Tremor
12%Edema
12%Anorexia
12%Dyspnea w/ADL
6%Renal failure
6%Hyperkalemia
6%Platelets
6%Mucositis/Stomatitis
6%Elevated Glucose
6%Alkaline Phosphatase
6%Alopecia
6%Blepharitis
6%Decreased hearing in left ear
6%Dyspepsia
6%Dehydration
6%Dizziness
6%Headache
6%Mucositis
6%Hypoxia
6%Elevated Heart Rate
6%Hypocalcemia
6%Vaginal Infection
6%Peripheral neuropathy
6%Magnesium
6%Upper respiratory infection
6%Pruritis
6%Cough
6%Vaginal dryness and irritation
6%White Blood Cells in Urine
6%Weight loss
6%Blurred vision
6%Severe pain (back)
6%Dysgeusia
6%Muscle weakness, generalized
6%dysmorphic nail bed
6%Hyponatremia
6%Joint pain
6%Vomiting
6%Fever
This histogram enumerates side effects from a completed 2012 Phase 2 trial (NCT00983307) in the Erlotinib and Radiotherapy ARM group. Side effects include: Rash with 71%, Death with 53%, Fatigue with 41%, Diarrhea with 41%, Bilirubin Increased with 35%.

Trial Design

1 Treatment Group

Hypofractionated Radiotherapy
1 of 1

Experimental Treatment

40 Total Participants · 1 Treatment Group

Primary Treatment: Hypofractionated Radiotherapy · No Placebo Group · Phase 2

Hypofractionated Radiotherapy
Radiation
Experimental Group · 1 Intervention: Hypofractionated Radiotherapy · Intervention Types: Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypofractionated Radiotherapy
2009
Completed Phase 2
~60

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 2 years

Who is running the clinical trial?

Vanderbilt-Ingram Cancer CenterLead Sponsor
202 Previous Clinical Trials
65,461 Total Patients Enrolled
Eric Shinohara, MD5.02 ReviewsPrincipal Investigator - Vanderbilt Medical Center
Vanderbilt-Ingram Cancer Center
5Patient Review
Dr. Shinohara was very patient with me as we discussed the pros and cons of various treatment options for my prostate cancer. In the end, he recommended a course of action that he thought would be best for me. I would definitely recommend him to others.

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you: