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Radiation Therapy

SBRT for Adenoid Cystic Carcinoma

N/A
Recruiting
Led By Jonathan D Schoenfeld, M.D., M.P.H.
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status of 0-2 (see Appendix A)
Age 18 years or older
Must not have
Evidence of need for urgent surgical intervention for metastatic CNS or spine disease
Bone metastasis in a femoral bone for which surgical stabilization is recommended
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from randomization to free of locoregional progression, assessed up to 5 years
Awards & highlights

Summary

This trial is studying how well SBRT works in treating patients with adenoid cystic carcinoma.

Who is the study for?
This trial is for adults with adenoid cystic carcinoma that has spread to other parts of the body. Participants should have 1-5 metastatic sites, a stable primary tumor, and an ECOG performance status of 0-2. Women must not be pregnant and agree to contraception measures. No recent systemic therapy (4 weeks before radiotherapy) is allowed.
What is being tested?
The SOLAR Trial is testing if starting stereotactic body radiation therapy (SBRT) early can affect the progression of advanced adenoid cystic carcinoma, improve quality of life, or increase survival compared to standard care.
What are the potential side effects?
Potential side effects from SBRT may include skin reactions at the treatment site, fatigue, temporary swelling or pain around treated areas, and less commonly changes in blood counts or lung inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of the day.
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I am 18 years old or older.
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I have 1 to 5 areas where cancer has spread, including in bones or brain.
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All my cancer spots can be treated with targeted radiation, as confirmed by a specialist.
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I haven't had cancer drugs or targeted therapy in the last 4 weeks.
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I have adenoid cystic carcinoma with distant metastases.
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My brain lesion is 3 cm or smaller.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need urgent surgery for cancer spread to my brain or spine.
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I have cancer spread to my thigh bone and need surgery to stabilize it.
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I have fluid buildup due to cancer in the lining of my lung.
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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
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I've had treatments like ablation or embolization for cancer spread and am now set for SBRT.
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All my cancer sites cannot be treated.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from randomization to free of locoregional progression, assessed up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and time from randomization to free of locoregional progression, assessed up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Local Control Rate (Cohort 2)
Progression Free Survival (PFS) (Cohort 1)
Secondary study objectives
Local Disease Control Rate
Overall Survival (OS)
Quality of Life (QOL) assessments by FACT-G
+3 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Diarrhea
9%
Anemia
9%
Shortness of Breath
9%
Abdominal pain
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Weight Loss
7%
Dyspnea
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Atrial fibrillation with rapid ventricular response
4%
Pleural effusion
2%
colitis
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Stereotactic Body Radiotherapy (SBRT) 1-5 Metastatic Sites (Cohort 1)Experimental Treatment1 Intervention
Participants will be randomly assigned and receive SBRT to 1-5 sites of metastatic disease over the course of 1-8 business days to each area of cancer. After SBRT is completed participant may go on to receive systemic therapy (like chemotherapy, immunotherapy, or targeted therapies) per discretion of their treating physician.
Group II: Standard of Care (Cohort 1)Active Control1 Intervention
Participants will be randomly assigned and receive standard of care as determined by their physician and may include: palliative radiation and/or a systemic therapy (like chemotherapy, immunotherapy, or targeted therapies).
Group III: Local Ablative Therapy (Cohort 2)Active Control1 Intervention
Participants embarking on standard of care local ablative therapy (not limited to radiofrequency, microwave, or cryoablation, bland or chemoembolization, palliative radiotherapy, or surgical metastasectomy) not eligible for cohort 1 will be enrolled and followed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SBRT
2014
Completed Phase 2
~1060

Find a Location

Who is running the clinical trial?

Adenoid Cystic Carcinoma Research FoundationUNKNOWN
6 Previous Clinical Trials
153 Total Patients Enrolled
Gateway for Cancer ResearchOTHER
45 Previous Clinical Trials
2,450 Total Patients Enrolled
Dana-Farber Cancer InstituteLead Sponsor
1,100 Previous Clinical Trials
353,031 Total Patients Enrolled

Media Library

SBRT (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04883671 — N/A
Adenoid Cystic Carcinoma Research Study Groups: Standard of Care (Cohort 1), Stereotactic Body Radiotherapy (SBRT) 1-5 Metastatic Sites (Cohort 1), Local Ablative Therapy (Cohort 2)
Adenoid Cystic Carcinoma Clinical Trial 2023: SBRT Highlights & Side Effects. Trial Name: NCT04883671 — N/A
SBRT (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04883671 — N/A
~38 spots leftby Jun 2028
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