A Phase II Trial of Stereotactic Ablative Body Radiation Therapy (SABR) for patients with primary Renal Cancer (RCC)
- Clements University Hospital
The study population for this trial is patients with biopsy proven primary RCC (Renal Cell Cancer)that are candidates for active surveillance (aS). Keeping patient safety in perspective, it is reasonable to offer an experimental treatment such as this to a patient population that would have otherwise been put in aS. at any sign of progression, the patients that have undergone SBRT (Stereotactic Body Radiation Therapy) in this trial will be offered the standard of care (SoC) of partial nephrectomy or ablation[?]which is same as what would have been offered to them had they been in aS (active surveillance).
9.1 Study Design/Study endpoints
This is an open label single-arm phase ii non-randomized prospective single arm study that treats a single SRM (Small Renal Mass) with SaBR (Stereotactic ablative Radiation Therapy). The primary objective is local control of the SRMs (Small Renal Masses) .Local control is defined as less than 4mm increase in the longest diameter of tumor measured using either MRi or contrast enhanced CT scan and with no radiographic or pathologic evidence of viable tumor. The endpoint will be measured at a minimum follow up of one year and a median of 2 years. Secondary objections and endpoints explore the safety, toxicity, growth, growth rate, local failure, iDR, immune response and progression of the SRMs (Small Renal Masses) after SaBR (Stereotactic ablative Radiation Therapy).
The stopping rules for this study include any treatment-related [Greater Than]grade 3 toxicity. if there are any treatment related grade 3 acute toxicity in [Greater Than]30% of enrolled patients after enrollment of at least 6 patients, the study will be suspended until permitted by a safety review.
1. Age >= 18 years.
2. Renal mass <= 3cm
The treating renal mass must be <= 3cm. Other renal masses (cysts etc.) >3cm will not make the subject ineligible
3. Biopsy proven Renal neoplasm
3.1 All histology of renal cancers are included including oncocytoma
4. Growth of renal mass >4mm in radiographic scans must be demonstrated within a one year period
5. Ability to understand and the willingness to sign a written informed consent.
7. Subjects is able to undergo either an MRI or administration of contrast agent for CT.