Trial Comparing Stereotactic Body Radiation Therapy to Radiofrequency Ablation for Renal Cell Carcinoma

NCT02138578 | Terminated Results DMC

• 2 other identifiers: UMCC 2013.069HUM00076618
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess whether Stereotactic Body Radiation Therapy (SBRT) can provide comparable local control, with similar or improved toxicity rates compared to Radio Frequency Ablation (RFA) when treating small renal cell carcinomas.

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• Proportion of Patients With Local Control of Disease

  On imaging, local control will be defined as when the treated lesion shows no enhancement.

  12 months

• Cumulative Incidence of Grade 2 and Greater Toxicities

  The number of patients reporting grade 2 and greater toxicities (for this trial the Common Terminology Criteria for Adverse Events or CTCAE was used).

  up to 30 days after the last study treatment

Secondary Outcomes (5)

• Difference in Quality of Life (QOL) Scores Between SBRT and RFA Treatment Arms

  Pre-study, last day of treatment; 1, 3, 6, 12, 18, 24 and 36 months post treatment

• Difference in Patient Time Away (Measured in Days) Between SBRT and RFA Treatment Arms

  Pre-study, last day of treatment; 1, 3, 6, 12, 18, 24 and 36 months post treatment

• Metastasis Free Survival Time

  36 months post treatment

• Overall Survival Time

  36 months post treatment

• Difference in Incidence of Treatment Related Pain Between SBRT and RFA Treatment Arms

  Pre-study, last day of treatment; 1, 3, 6, 12, 18, 24 and 36 months post treatment

Study Arms (3)

Randomized SBRT

EXPERIMENTAL

Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Stereotactic Body Radiation Therapy (SBRT) will receive SBRT delivered in fractions of 20 Gy, approximately every other day, for a total of three treatments. If the target is deemed too close to organs at risk, 5 fractions of up to 10 Gy per fraction will be prescribed.

Radiation: SBRT

Randomized RFA

ACTIVE COMPARATOR

Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Radiofrequency Ablation (RFA) will receive RFA.

Radiation: RFA

Non-Randomized SBRT

ACTIVE COMPARATOR

Patients with renal cell carcinoma's greater than or equal to 4 cm in diameter, and up to 8 cm in diameter, may be placed in the non-randomized stereotactic body radiation therapy arm. Patients with tumors not amenable to RFA, those with metastatic disease, and those who elect a noninvasive means of treatment will also be eligible to receive treatment in the non-randomized SBRT cohort.

Radiation: SBRT

Interventions

SBRT RADIATION

Also known as: Stereotactic Body Radiation Therapy

Non-Randomized SBRT; Randomized SBRT

RFA RADIATION

Also known as: Radiofrequency Ablation

Randomized RFA

Eligibility Criteria

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

You may qualify if:

• Patients with renal cell carcinoma less than 4 cm in maximum diameter, who are poor surgical candidates are eligible for randomization between SBRT and RFA (Renal cell carcinoma must be pathologically proven).
• The primary tumor must be in a location amendable to RFA within the kidney.
• Patients must be appropriate candidates for RFA, with platelets ≥50,000/mm3 and an international normalized ratio of 1.5.
• Patients must have an ECOG (a measurement of general well being and activities of daily living; scores range from 0 to 5 where 0 represents perfect health) score ≤ 3.
• There is no required minimum renal function (patients will be counseled about the possible need for dialysis, if applicable, just as would be the case for radical or partial nephrectomy).
• Patients must sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of the University of Michigan Medical Center indicating that they are aware of the investigational aspects of the treatment and the potential risks.
• Ability to understand and the willingness to sign a written informed consent.
• If a patient is randomized to the RFA arm, but is deemed not to be an anesthesia candidate, he/she will be placed in the non-randomized SBRT cohort.
• Patients with renal cell carcinoma less than 8 cm in maximum diameter, patients with metastatic RCC who require local palliation or are progressing through systemic disease, patients who are poor surgical candidates and have tumor location not amenable to RFA, or patients who would prefer a noninvasive means of treatment are eligible for the non-randomized SBRT cohort (Renal cell carcinoma must be pathologically proven).
• There are no limitations based on location of the primary tumor within the kidney.
• Patients must have an ECOG score ≤ 3.
• There is no required minimum renal function (patients will be counseled about the possible need for dialysis, if applicable, just as would be the case for radical or partial nephrectomy).
• Patients must sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of the University of Michigan Medical Center indicating that they are aware of the investigational aspects of the treatment and the potential risks.
• Ability to understand and the willingness to sign a written informed consent.

You may not qualify if:

• Patients younger than 18 or pregnant women.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Radiosurgery; Radiofrequency Ablation

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; Radiofrequency Therapy; Ablation Techniques

Results Point of Contact

• Title: Dr. Daniel Spratt, M.D.
• Organization: University of Michigan Comprehensive Cancer Center

sprattda@med.umich.edu

734-936-4300

Study Officials

• Daniel Spratt, M.D.

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2014
• First Posted: May 14, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: February 1, 2017
• Last Updated: November 7, 2017
• Results First Posted: November 7, 2017

Record last verified: 2017-10

Locations

US (1)