CLINICAL TRIAL / NCT04883671
Stereotactic Body Radiotherapy (SBRT) for Early Treatment of Oligometastatic Adenoid Cystic Carcinoma: The SOLAR Trial
- Interventional
- Recruiting
- NCT04883671
Contact Information
Stereotactic Body Radiotherapy (SBRT) for Early Treatment of Oligometastatic Adenoid Cystic Carcinoma: The SOLAR Trial
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)
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). Given the overall
uncertainty about the role of local therapy in the treatment of ACC, there is also a
prospective observational cohort that will investigate outcomes following local ablative
treatments in patients with advanced or metastatic ACC.
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 five) 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 will 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.
Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers
No
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)
- 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.
"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:
- 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.
- Malignant pleural effusion.
- 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.