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Radiation
5-Day Preoperative Radiotherapy for Soft Tissue Sarcoma
Phase 2
Recruiting
Led By Anusha Kalbasi, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed soft tissue sarcoma of the extremity, trunk or retroperitoneum
Has been offered preoperative radiation and surgery as part of standard-of-care treatment
Must not have
History of prior radiation to the area to be treated
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 120 days after surgery
Awards & highlights
No Placebo-Only Group
Summary
This trial will examine a shorter course of radiation to treat soft tissue sarcomas. Instead of 25 days, it may only need 5.
Who is the study for?
This trial is for adults over 18 with confirmed soft tissue sarcoma in limbs, trunk, or retroperitoneum. Participants must have a life expectancy of at least 6 months and be fit enough for standard preoperative radiation and surgery. Women able to bear children need a negative pregnancy test. Those who've had prior radiation in the area or plan to use other cancer treatments like chemo alongside can't join.
What is being tested?
The study tests the safety and effectiveness of a short, 5-day course of preoperative external beam radiotherapy for soft tissue sarcoma patients compared to the usual longer treatment that takes about 25 days.
What are the potential side effects?
Potential side effects may include skin changes, fatigue, swelling in treated areas, pain or discomfort during treatment sessions. Long-term effects could involve changes to bone or muscle structure and function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is a type of sarcoma found in my limbs, trunk, or behind the abdomen.
Select...
I have been recommended radiation and surgery before other treatments.
Select...
I can take care of myself and perform daily activities.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had radiation therapy on the area that needs treatment now.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 120 days after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~120 days after surgery
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Post-operative Complication Rate
Secondary study objectives
Local Recurrence Rate
Side effects data
From 2018 Phase 1 trial • 51 Patients • NCT0278359953%
Nausea
47%
Fatigue
43%
Stomatitis
39%
Constipation
33%
Decreased appetite
31%
Alopecia
25%
Asthenia
24%
Vomiting
24%
Diarrhoea
22%
Anaemia
22%
Neutrophil count decreased
20%
Neutropenia
18%
Febrile neutropenia
18%
Pyrexia
18%
White blood cell count decreased
18%
Dizziness
16%
Myalgia
16%
Headache
14%
Abdominal pain
14%
Oropharyngeal pain
14%
Oedema peripheral
12%
Dyspepsia
12%
Insomnia
12%
Arthralgia
12%
Dysgeusia
10%
Abdominal pain upper
8%
Flatulence
8%
Procedural pain
8%
Chills
8%
Platelet count decreased
8%
Pain in extremity
8%
Tumour pain
6%
Anxiety
6%
Abdominal distension
6%
Hypoalbuminaemia
6%
Urinary tract infection
6%
Infusion related reaction
6%
Blood creatinine increased
6%
Hypokalaemia
6%
Catarrh
6%
Rash
6%
Cough
6%
Dyspnoea
4%
Sepsis
2%
Deep vein thrombosis
2%
Atrial fibrillation
2%
Gastrointestinal obstruction
2%
Anaphylactic reaction
2%
Device related infection
2%
Cardiopulmonary failure
2%
Bronchitis
2%
Influenza
2%
Guillain-barre syndrome
2%
Intestinal perforation
2%
Anal abscess
2%
Joint effusion
2%
Encephalopathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Olaratumab + Doxorubicin
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: External beam radiotherapyExperimental Treatment1 Intervention
Patients will receive treatment with external beam radiotherapy at a total of 30 Gy delivered over five fractions delivered daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
External Beam Radiotherapy
1995
Completed Phase 3
~440
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,491 Previous Clinical Trials
17,519,137 Total Patients Enrolled
Anusha Kalbasi, MDPrincipal InvestigatorStanford University
1 Previous Clinical Trials
24 Total Patients Enrolled