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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from randomization to free of locoregional progression, assessed up to 5 years

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

Diarrhea

Anemia

Shortness of Breath

Abdominal pain

Kidney Injury and/or Infection

Pneumonia

Weight Loss

Dyspnea

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Atrial fibrillation with rapid ventricular response

Pleural effusion

colitis

Thrombocytopenia

Respiratory failure

Skin rash

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 13Eligibility criteria met