RECRUITING

Stereotactic Body Radiotherapy (SBRT) for Early Treatment of Oligometastatic Adenoid Cystic Carcinoma: the SOLAR Trial

Conditions

Adenoid Cystic Carcinoma Metastatic Adenoid Cystic Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The aim of this study is to learn whether the early initiation of a specialized and focused type of radiation called stereotactic body radiation therapy (SBRT) will impact the progression of advanced adenoid cystic carcinoma, quality of life, and overall survival. The name(s) of the study intervention involved in this study is: * Stereotactic Body Radiation Therapy (SBRT)

Official Title

Stereotactic Body Radiotherapy (SBRT) for Early Treatment of Oligometastatic Adenoid Cystic Carcinoma: the SOLAR Trial

Quick Facts

Study Start:2021-12-27

Study Completion:2030-06-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04883671

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Subject must have histologically confirmed adenoid cystic carcinoma (ACC) of any primary site with distant metastases detected clinically or on imaging (biopsy of metastatic disease preferred, but not required) * Cohort 1 * One to five detectable sites of metastatic disease at any organ or site (including bone and CNS involvement) * Maximum size of 3 cm for brain lesions. * Note: Measurable disease is not required * Note: Patients with isolated intracranial disease for whom SRS would be the preferred standard of care are not eligible. * Note: Patients may have additional sites of disease for which radiation is not feasible or indicated provided this disease is: 1) Less than 1 cm in maximum diameter on most recent imaging; or 2) Stable over the last 3 months as determined by the investigator * Cohort 2 * At least 1 site of non-osseous disease * Cohort 1 * All (up to 5) metastatic foci should be amenable to SBRT as per review by a radiation oncologist based on protocol specified dose / dose constraints (there is no prespecified minimum or maximum size) * Cohort 2 * At least one metastatic focus amenable to local ablative treatment with any of the following: radiation therapy; radiofrequency, microwave, or cryoablation; bland or chemoembolization * Cohort 1 * Primary tumor either controlled, or amenable for local treatment with SBRT * Defined as no evidence of progression at primary or local site of disease (if known) within 6 months prior to enrollment * Age 18 years or older * ECOG performance status of 0-2 * Prior systemic therapy is allowed but no therapy (cytotoxic or molecularly targeted agents) 2 weeks prior to the first fraction of radiotherapy, and until after the last fraction of SBRT. * Cohort 1 * For patients with metastases that have been previously treated (prior resection, radiotherapy, radiofrequency or cryoablation): * If the previously treated site is controlled based on imaging, the patient is eligible for this trial and does not need further treatment of the controlled site * If the previously treated site is not controlled based on imaging, the patient is eligible for this trial as long as the site is amenable to SBRT * Ability to understand and the willingness to sign a written informed consent document. * Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of (chemo)radiation therapy. * Men who are sexually active with WOCBP must agree to use any contraceptive method with a failure rate of less than 1% per year. Men who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 1 month after treatment. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception. See Appendix B for further guidance on contraception.	* Cohort 1 * Subject who has received systemic therapy for treatment of ACC within 2 weeks of enrollment. * Evidence of need for urgent surgical intervention for metastatic CNS or spine disease. * Cohort 1 * Alternative locally ablative therapies received (radiofrequency ablation, cryotherapy, or \[chemo\]embolization) for any metastatic foci planned for SBRT at the time of study enrollment that precludes administration of SBRT. * Bone metastasis in a femoral bone for which surgical stabilization is recommended. * Cohort 1 * Active disease \>1 cm that is progressing and not amenable to SBRT. * Pregnant or lactating women. * Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Has a known additional malignancy that is progressing or requires active treatment. Exceptions: include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer, and low-risk prostate adenocarcinoma being managed with active surveillance. A history of another separate malignancy in remission without evidence of active disease in the last 2 years is permitted.

Inclusion Criteria

Exclusion Criteria

* Subject must have histologically confirmed adenoid cystic carcinoma (ACC) of any primary site with distant metastases detected clinically or on imaging (biopsy of metastatic disease preferred, but not required)
* Cohort 1
* One to five detectable sites of metastatic disease at any organ or site (including bone and CNS involvement)
* Maximum size of 3 cm for brain lesions.
* Note: Measurable disease is not required
* Note: Patients with isolated intracranial disease for whom SRS would be the preferred standard of care are not eligible.
* Note: Patients may have additional sites of disease for which radiation is not feasible or indicated provided this disease is: 1) Less than 1 cm in maximum diameter on most recent imaging; or 2) Stable over the last 3 months as determined by the investigator
* Cohort 2
* At least 1 site of non-osseous disease
* Cohort 1
* All (up to 5) metastatic foci should be amenable to SBRT as per review by a radiation oncologist based on protocol specified dose / dose constraints (there is no prespecified minimum or maximum size)
* Cohort 2
* At least one metastatic focus amenable to local ablative treatment with any of the following: radiation therapy; radiofrequency, microwave, or cryoablation; bland or chemoembolization
* Cohort 1
* Primary tumor either controlled, or amenable for local treatment with SBRT
* Defined as no evidence of progression at primary or local site of disease (if known) within 6 months prior to enrollment
* Age 18 years or older
* ECOG performance status of 0-2
* Prior systemic therapy is allowed but no therapy (cytotoxic or molecularly targeted agents) 2 weeks prior to the first fraction of radiotherapy, and until after the last fraction of SBRT.
* Cohort 1
* For patients with metastases that have been previously treated (prior resection, radiotherapy, radiofrequency or cryoablation):
* If the previously treated site is controlled based on imaging, the patient is eligible for this trial and does not need further treatment of the controlled site
* If the previously treated site is not controlled based on imaging, the patient is eligible for this trial as long as the site is amenable to SBRT
* Ability to understand and the willingness to sign a written informed consent document.
* Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of (chemo)radiation therapy.
* Men who are sexually active with WOCBP must agree to use any contraceptive method with a failure rate of less than 1% per year. Men who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 1 month after treatment. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception. See Appendix B for further guidance on contraception.

* Cohort 1
* Subject who has received systemic therapy for treatment of ACC within 2 weeks of enrollment.
* Evidence of need for urgent surgical intervention for metastatic CNS or spine disease.
* Cohort 1
* Alternative locally ablative therapies received (radiofrequency ablation, cryotherapy, or \[chemo\]embolization) for any metastatic foci planned for SBRT at the time of study enrollment that precludes administration of SBRT.
* Bone metastasis in a femoral bone for which surgical stabilization is recommended.
* Cohort 1
* Active disease \>1 cm that is progressing and not amenable to SBRT.
* Pregnant or lactating women.
* Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Has a known additional malignancy that is progressing or requires active treatment. Exceptions: include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer, and low-risk prostate adenocarcinoma being managed with active surveillance. A history of another separate malignancy in remission without evidence of active disease in the last 2 years is permitted.

Contacts and Locations

Study Contact

Jonathan D Schoenfeld, MD, MPH

CONTACT

617-632-5296

jonathan_schoenfeld@dfci.harvard.edu

Glenn J Hanna, MD

CONTACT

617-632-3090

glenn_hanna@dfci.harvard.edu

Principal Investigator

Jonathan D Schoenfeld, MD, MPH

PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Study Locations (Sites)

University of California, San Francisco

San Francisco, California, 94158

United States

University of Chicago

Chicago, Illinois, 60637

United States

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

Jonathan D Schoenfeld, MD, MPH, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-27

Study Completion Date2030-06-01

Study Record Updates

Study Start Date2021-12-27

Study Completion Date2030-06-01

Terms related to this study

Keywords Provided by Researchers

Adenoid Cystic Carcinoma
Metastatic Adenoid Cystic Carcinoma

Additional Relevant MeSH Terms

Adenoid Cystic Carcinoma
Metastatic Adenoid Cystic Carcinoma