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Radiation Therapy
Reduced-Dose IMRT for Soft Tissue Sarcoma
Phase 2
Recruiting
Led By Kaled Alektiar, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing if a lower dose of radiation can still be effective in treating soft tissue sarcomas and if it has fewer side effects than the standard dose.
Who is the study for?
This trial is for adults over 18 with a confirmed diagnosis of soft tissue sarcoma in the arms or legs, who've had successful tumor removal surgery. They must start radiation within 3 months post-surgery or chemo and agree to use contraception if applicable. It's not for those with positive surgical margins, certain types of myxofibrosarcoma, multifocal disease, prior radiotherapy in the area, active treatment for another invasive cancer, or conditions making them unsuitable as per investigator judgment.
What is being tested?
The study tests whether a reduced dose and targeted area of postoperative radiation therapy are as effective as standard doses/volumes in controlling soft tissue sarcoma after surgery. The goal is also to see if this method results in fewer severe long-term side effects compared to the traditional approach.
What are the potential side effects?
While specific side effects aren't listed here, generally intensity-modulated radiation therapy (IMRT) can cause skin changes like redness and irritation at the treatment site, fatigue during treatment periods and sometimes mild swelling or scarring of treated tissues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Assessment of local control at 2 years.
Secondary study objectives
overall survival
Side effects data
From 2021 Phase 2 trial • 38 Patients • NCT0452985068%
Lymphopenia
51%
Nausea
41%
Leukopenia
38%
Anaemia
27%
Constipation
27%
Neutropenia
24%
Hypomagnesamia
24%
Decreased Appetite
22%
Dysphagia
22%
Hypokalaemia
22%
Vomiting
19%
Pyrexia
19%
Diarrhoea
19%
Asthenia
19%
Dermatitis
19%
Radiation Skin Injury
19%
Hypotension
16%
Dyspepsia
16%
Thrombocytopenia
14%
Weight Decreased
14%
Oral Pain
14%
Dry Mouth
11%
Oral Candidiasis
8%
Pneumonia
5%
COVID 19
3%
Dehydration
3%
Tumor Haemorrhage
3%
Renal Failure
3%
Oropharyngeal Pain
3%
Device Related Infection
3%
Stoma Site Infection
3%
Febrile Neutropenia
3%
Leuokopenia
3%
Colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Open Label Active Arm
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: extremity soft tissue sarcoma (STS)Experimental Treatment1 Intervention
Postoperative radiation therapy to the primary site with a reduction in radiation dose and volume. Specifically, the tumor bed plus a margin of 2cm craniocaudally and 1.5cm radially will be utilized to create the clinical target volume. The total dose will consist of 50 Gy in 25 fractions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intensity-modulated radiation therapy (IMRT)
2020
Completed Phase 2
~140
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,972 Previous Clinical Trials
597,668 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,817 Previous Clinical Trials
8,161,699 Total Patients Enrolled
Kaled Alektiar, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not receiving treatment for another type of invasive cancer.My sarcoma diagnosis in my arm or leg has been confirmed by a specialist.I am a woman who can have children and have a recent negative pregnancy test.My surgery for cancer left some cancer cells, as confirmed by a pathology review.I am 18 years old or older.My cancer surgery removed all visible cancer, confirmed by a pathology review.I can start radiation therapy within 3 months after my surgery.I have been diagnosed with a specific type of soft tissue cancer that is difficult to define on an MRI.I have multiple tumors in one of my limbs.I have had radiation therapy on or near where my cancer started.I will start radiation therapy within 3 months after finishing chemotherapy.My treatment may include chemotherapy, as decided by my healthcare team.I agree to use effective birth control if I can have children.
Research Study Groups:
This trial has the following groups:- Group 1: extremity soft tissue sarcoma (STS)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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