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Radiation Therapy

SBRT for Adenoid Cystic Carcinoma

N/A
Recruiting
Led By Jonathan D Schoenfeld, MD, MPH
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from randomization to free of locoregional progression, assessed up to 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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My primary cancer has not worsened in the last 6 months.
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All my cancer spots can be treated with targeted radiation, as confirmed by a specialist.
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I have a cancer spot that can be treated with targeted therapy like radiation or ablation.
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I haven't had cancer drugs or targeted therapy in the last 4 weeks.
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I have at least one cancer site that's not in the bones.
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I have adenoid cystic carcinoma with distant metastases.
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I have confirmed I am not pregnant and will use effective birth control during and after treatment.
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My treated cancer spread is under control or can be treated with SBRT if not controlled.
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My brain lesion is 3 cm or smaller.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Local Control Rate (Cohort 2)
Progression Free Survival (PFS) (Cohort 1)
Secondary outcome measures
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%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
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
Dana-Farber Cancer InstituteLead Sponsor
1,077 Previous Clinical Trials
340,677 Total Patients Enrolled
Gateway for Cancer ResearchOTHER
45 Previous Clinical Trials
2,504 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What objectives is this research project seeking to accomplish?

"The main goal of the research, which will be monitored over a 5 year period from randomization to local progression or death, is to assess Local Control Rate (Cohort 2). Secondary objectives include gauging Overall Survival using RECIST v1.1 and Kaplan-Meier techniques, determining Toxicity Rates with Common Terminology Criteria for Adverse Events version 5.0 and Quality of Life evaluations through FACT-G descriptive statistic methods."

Answered by AI

Is this medical investigation currently recruiting participants?

"Affirmative. According to clinicaltrials.gov, recruitment for this trial is still open after it was first posted on December 27th 2021 and last updated September 20th 2022. 66 applicants are needed at 3 separate sites."

Answered by AI

What is the participant count for this investigation?

"Affirmative. According to records on clinicaltrials.gov, this trial is presently recruiting volunteers and has been since December 27th 2021. 66 individuals are needed from 3 different medical centers for the current iteration of the study that was last updated in September 2022."

Answered by AI
~43 spots leftby Jun 2028