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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 120 days after surgery

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

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My cancer is a type of sarcoma found in my limbs, trunk, or behind the abdomen.

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I have been recommended radiation and surgery before other treatments.

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I can take care of myself and perform daily activities.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 120 days after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~120 days after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 120 days after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Post-operative Complication Rate

Secondary outcome measures

Local Recurrence Rate

Side effects data

From 2018 Phase 1 trial • 51 Patients • NCT02783599

53%

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%

Insomnia

12%

Dyspepsia

12%

Arthralgia

12%

Dysgeusia

10%

Abdominal pain upper

Flatulence

Procedural pain

Chills

Platelet count decreased

Pain in extremity

Tumour pain

Hypoalbuminaemia

Anxiety

Abdominal distension

Urinary tract infection

Infusion related reaction

Blood creatinine increased

Hypokalaemia

Catarrh

Rash

Cough

Dyspnoea

Sepsis

Anal abscess

Influenza

Guillain-barre syndrome

Joint effusion

Encephalopathy

Deep vein thrombosis

Gastrointestinal obstruction

Intestinal perforation

Cardiopulmonary failure

Anaphylactic reaction

Bronchitis

Device related infection

Atrial fibrillation

100%

80%

60%

40%

20%

Study treatment Arm

Olaratumab + Doxorubicin

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,395 Previous Clinical Trials

17,341,280 Total Patients Enrolled

Anusha Kalbasi, MDPrincipal InvestigatorStanford University

1 Previous Clinical Trials

24 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 available vacancies for participants in this research project?

"Affirmative. The information found on clinicaltrials.gov declares that this study is actively seeking participants; it was first listed on October 6th, 2023 and recently updated the 11th of the same month. 75 volunteers are required from a single location for enrollment into this trial."

Answered by AI

What adverse impacts could be experienced from External beam radiotherapy?

"External beam radiotherapy is believed to be moderately safe, as indicated by a rating of 2. This evaluation was reached due to the presence of some safety data but no efficacy studies yet conducted."

Answered by AI

How many participants are contributing to this clinical experiment?

"Affirmative. Per the details found on clinicaltrials.gov, this medical investigation is actively recruiting participants and was first posted on October 6th 2023 with its most recent update occurring 5 days later. The trial requires 75 patients from 1 centre to be recruited."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

5-Day Preoperative Radiation for Soft Tissue Sarcoma

2023. "5-Day Preoperative Radiation for Soft Tissue Sarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06087861.

All > Soft Tissue Sarcoma