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

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Brief Title

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

Official Title

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

Brief Summary

      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)
    

Detailed Description

      This is a randomized phase II, open-label and non-blinded two-arm study aimed to investigate
      the potential benefit of treating oligometastatic adenoid cystic carcinoma (ACC) with early
      initiation of stereotactic body radiotherapy (SBRT).

      This research study is investigating how the specialized and focused stereotactic body
      radiation therapy (SBRT) impacts disease progression, quality of life, and overall survival
      in patients with a limited number of metastases (one to three) from their adenoid cystic
      carcinoma cancer. The use of SBRT to treat all areas of disease after early spread of ACC is
      investigational. SBRT is a more focused form of radiation compared to the palliative
      radiation typically received per standard of care treatment. Recent retrospective studies
      conducted suggest that patients with adenoid cystic carcinoma cancer may benefit from early
      initiation of a targeted radiation therapy.

      The research study procedures include screening for eligibility and study treatment including
      evaluations and follow up visits. After enrollment participants wil be randomized into two
      groups: Standard of Care or Stereotactic body radiotherapy (SBRT). All participants in the
      study, regardless of treatment regimen, will be followed for up to 10 years.

      It is expected that about 66 people will take part in this research study.

      Two organizations, Gateway for Cancer Research and the Adenoid Cystic Carcinoma Research
      Foundation (ACCRF), are supporting this research study by providing funding.
    


Study Type

Interventional


Primary Outcome

Progression Free Survival (PFS)

Secondary Outcome

 Overall Survival (OS)

Condition

Adenoid Cystic Carcinoma

Intervention

Standard of Care

Study Arms / Comparison Groups

 Standard of Care
Description:  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).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

66

Start Date

October 2021

Completion Date

June 1, 2030

Primary Completion Date

June 1, 2028

Eligibility Criteria

        Inclusion 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)

          -  One to three 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.

          -  All (up to 3) 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)

          -  Controlled primary tumor

          -  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 (see Appendix A)

          -  Prior systemic therapy is allowed but no therapy (cytotoxic or molecularly targeted
             agents) 4 weeks prior to the first fraction of radiotherapy, and until after the last
             fraction of SBRT.

          -  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 was treated by surgery only (not RFA
                  or RT) and if 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.

        "Women of childbearing potential (WOCBP)" is defined as any female who has experienced
        menarche and who has not undergone surgical sterilization (hysterectomy or bilateral
        oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of
        amenorrhea in a woman over 45 in the absence of other biological or physiological causes.
        In addition, women under the age of 55 must have a documented serum follicle stimulating
        hormone (FSH) level less than 40 mIU/mL.

          -  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.

        Exclusion Criteria:

          -  Subject who has received systemic therapy for treatment of ACC within 4 weeks of
             enrollment.

          -  Evidence of need for urgent surgical intervention for metastatic CNS or spine disease.

          -  Alternative locally ablative therapies received (radiofrequency ablation, cryotherapy,
             or [chemo]embolization) for any metastatic foci planned for SBRT at the time of study
             enrollment.

          -  Bone metastasis in a femoral bone for which surgical stabilization is recommended.

          -  Malignant pleural effusion.

          -  Inability to treat all sites of active disease.

          -  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.

          -  Inability to treat all sites of active disease.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jonathan D Schoenfeld, M.D., M.P.H., 617.632.5296, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04883671

Organization ID

21-171


Responsible Party

Principal Investigator

Study Sponsor

Dana-Farber Cancer Institute

Collaborators

 Adenoid Cystic Carcinoma Research Foundation

Study Sponsor

Jonathan D Schoenfeld, M.D., M.P.H., Principal Investigator, Brigham and Women's Hospital


Verification Date

June 2021