Clinical trial NCT04580836: MRI-Guided Radiation Therapy for the Treatment of Early-Stage Kidney Cancer, the MRI-MARK Trial
Official title: MRI-Guided Stereotactic Body Radiotherapy for the Treatment of Early Stage Kidney Cancer: A Single Arm Phase II Clinical Trial (MRI-MARK)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Renal Cell Carcinoma
Stage I Renal Cell Cancer AJCC v8
Stage II Renal Cell Cancer AJCC v8
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-10-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This phase II trial investigates how well MRI-guided stereotactic body radiation therapy works in treating patients with early-stage kidney cancer. Radiation therapy uses high energy radiation to kill tumor cells and shrink tumors. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. This method of radiation delivery is further refined through the incorporation of a MRI into the radiation machine to create a device known as a MRI linear accelerator. During treatment with MRI linear accelerator, continuous MRI images are obtained to allow for real-time treatment monitoring and the ability to adjust treatment plans if minor deviations in anatomy are noted. Giving MRI-guided stereotactic body radiation therapy may help treat patients with early-stage kidney cancer.

Detailed description: PRIMARY OBJECTIVE:

I. To evaluate local control following magnetic resonance imaging (MRI)-guided stereotactic body radiation therapy (SBRT) for primary kidney cancer as defined by no growth by imaging at 24 months following SBRT.

SECONDARY OBJECTIVES:

I. To estimate preservation of renal function and to determine frequency of grade 3+ adverse events following SBRT as per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

II. To characterize tumor and treated kidney changes by multiparametric MRI, including utility of diffusion and perfusion changes in renal cell carcinoma (RCC) prior to and after SBRT as biomarkers of treatment response.

III. To estimate the rate of pathologic complete response as determined by tumor biopsy at 24 months following SBRT.

IV. To estimate rate of no progression by Response Evaluation Criteria in Solid Tumors (RECIST) at 24 months (less than 20% growth in largest tumor dimension as measured by imaging).

V. To estimate the rates of overall survival and distant metastasis. VI. To evaluate economic strain following SBRT for primary kidney cancer. VII. Compare planned total doses to true total doses delivered to the target and adjacent normal structures, to correlate true delivered doses to normal structures to grade 3+ toxicity, and to determine the rate of cases in which the prescribed isodose line failed to cover 100% of the internal gross tumor volume (iGTV).

OUTLINE:

Patients undergo an MRI scan to check the status and location of the disease, including the motion of the tumor during breathing. Two weeks after MRI, patients undergo SBRT over 1-2 hours on 3 non-consecutive weekdays in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 3, 6, 12, 18, and 24 months, then every 6 months thereafter until the end of the study.

Eligibility criteria: Inclusion Criteria:

* Patients may enter the study if they are diagnosed with bilateral kidney cancer, multiple lesions in the same kidney, recurrent kidney cancer, or if they have previous or current history of a separate cancer, given all other inclusion criteria met
* Have a pathologically confirmed diagnosis of renal cell carcinoma (RCC) of any histology
* Be a suboptimal surgical or ablation candidate, as determined by patient's primary urologist at MD Anderson Cancer Center and by multi-disciplinary consensus. At or before the time of enrollment, a note documenting multidisciplinary consensus supporting active treatment will be recorded in the patient's chart
* Tumor stage of T1-T2a (i.e. 10cm or less in greatest dimension)
* Be technically and anatomically appropriate for MRI-guided SBRT, as determined by patient's primary radiation oncologist. Factors considered will include distance between tumor and bowel, tumor movement with respiration as assessed by 4-dimensional (4D) computed tomography (CT) scan, and prior radiotherapy
* Multi-disciplinary consensus that active treatment is warranted
* Have Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Have life expectancy of 2 years or more

Exclusion Criteria:

* An MRI contraindication (i.e. pacemaker, severe claustrophobia, or MRI-incompatible device)
* A pre-treatment estimated glomerular filtration rate \< 30 cc/min
* Visceral, nodal, or bony metastatic disease
* Is pregnant or expecting to conceive within the projected duration of the trial at the screening visit

  * Female subject of childbearing potential should have a negative urine or serum pregnancy within 6 weeks prior to study registration up to the first fraction of radiation
  * Note: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
* Has a diagnosis of active scleroderma, lupus, or other rheumatologic disease which in the opinion of the treating radiation oncologist precludes safe radiation therapy
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

Primary outcomes:
measure: Time to progression
timeFrame: at 24 months
Secondary outcomes:
measure: Preservation of renal function
timeFrame: Baseline to 24 months
measure: Treatment related toxicities
timeFrame: Up to 24 months after completion of SBRT
measure: Changes in the imaging of primary tumor and treated kidney
timeFrame: Baseline up to 24 months after completion of SBRT
measure: Pathologic response
timeFrame: At 24 months
measure: Progression free survival
timeFrame: At 24 months
measure: Distant metastasis-free survival
timeFrame: Up to 24 months
measure: Overall survival
timeFrame: Up to 24 months
measure: Economic strain of MRI-guided SBRT
timeFrame: Baseline to 24 months
measure: Planned doses
timeFrame: up to 1 month
measure: Correlation of normal tissue true delivered doses with grade 3+ toxicity
timeFrame: Up to 24 months after completion of SBRT
measure: Rate of cases in which the prescribed isodose line failed to cover 100% of the internal gross tumor volume (iGTV)
timeFrame: Up to 24 months after completion of SBRT
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Chad Tang
role: PRINCIPAL_INVESTIGATOR
References: