To Evaluate Stereotactic Body Radiotherapy for Treatment of Primary Renal Cell Carcinoma Tumors

NCT02410174 | Terminated Phase 1

• 1 other identifier: 100-11
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of the use of stereotactic body radiotherapy (SBRT) for the treatment of the primary tumor in renal cell carcinoma (RCC) in medically inoperable patients and/or patients who refuse surgery. Standard treatment of RCC is surgery. A number of non-surgical treatments of RCC are also available, but are highly invasive and are associated with significant side effects. SBRT is a non-invasive, non-surgical treatment that requires tumor immobilization and image guidance in order to deliver a very precise, high-dose treatment. This trial will assess the use of SBRT to treat primary renal tumors by determining the maximum tolerated dose and toxicity. Subjects enrolled in this study will then be followed and evaluated for toxicity, serum chemistry, complete blood count, and urinalysis. In addition, they will undergo renal scans to assess the functionality of their renal tissue.

Conditions

Primary Tumor; Renal Cell Carcinoma

Keywords

Renal Cell Carcinoma; RCC; Stereotactic Body Radiotherapy; SBRT

Outcome Measures

Primary Outcomes (1)

• Local Failure

  A ≥20% increase in the sum of the diameters of the tumor with a minimum increase in the sum of 5 mm (RECIST criteria) or any areas of enhancement on follow up imaging studies is categorized as progression. Time to failure will be from the last date of SBRT to date of local failure or last follow-up. * Local failure will be classified as in field if it occurs within the treated volume or marginal if it occurs at the edge of the treated volume. * Development of a new renal tumor elsewhere in the kidney. This will not be considered a local failure. Time to development of a new tumor elsewhere in the kidney will be from the last date of SBRT to date of the event or last follow-up.

  up to 10 years

Secondary Outcomes (6)

• Regional Nodal Failure

  up to 10 years

• Metastases

  up to 10 years

• Overall survival

  up to 10 years

• Serum Creatinine Level

  1 year

• 24 Hour Creatinine Clearance

  1 year

Study Arms (1)

Stereotactic Body Radiotherapy (SBRT)

EXPERIMENTAL

Starting dose of 48Gy in 3 fractions, will escalate dose by 2 Gy per fraction (a 6Gy total dose) to a maximum dose of 20Gy x 3 fractions (TD 60 Gy in 3 fractions).

Radiation: Stereotactic Body Radiotherapy (SBRT)

Interventions

Stereotactic Body Radiotherapy (SBRT) RADIATION

Stereotactic Body Radiotherapy (SBRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient with a primary renal cell carcinoma (RCC) tumor who is inoperable for technical (i.e surgical) or medical reasons
• Patient must be screened by a urologic surgeon to verify eligibility on the above basis
• Biopsy proof of RCC is preferred; however, in current practice the diagnosis is often clinical based on characteristic imaging. If there are compelling clinical reasons not to proceed with biopsy, the clinical diagnosis will suffice.
• Patient with metastases are eligible if in the opinion of the treating physicians the patient could benefit from treatment of the primary renal tumor.
• ECOG performance status 0-2
• Age ≥18 years
• Signed informed consent

You may not qualify if:

• Inadequate renal function, as measured by creatinine clearance calculated from 24 hour urine collection. Creatinine clearance values of at least 50 ml/min are required
• Prior attempt at curative treatment of this primary kidney tumor
• Inability to lie still for approximately 1 hour in immobilization device
• Presence of a connective tissue disorder other than rheumatoid arthritis.
• Pregnancy
• Inability to develop a radiation treatment plan that adheres to the dose constraints described below in Radiotherapy Treatment Planning section.

Sponsors & Collaborators

• Beth Israel Medical Center: lead

Study Sites (2)

Mount Sinai Beth Israel Hospital

New York, New York, 10003, United States

Location

Mount Sinai Roosevelt Hospital

New York, New York, 10014, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ronald D Ennis, MD

  Mount Sinai Beth Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2015
• First Posted: April 7, 2015
• Study Start: May 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 9, 2017

Record last verified: 2016-04

Locations

US (2)