A Phase II Study of Cyberknife Radiosurgery for Renal Cell Carcinoma

NCT01890590 | Recruiting DMC

• 1 other identifier: 12-235
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

CyberKnife Based Radiosurgery is a way to deliver large doses of radiation very accurately to a tumor. The ability of this technology to minimize radiation dose to organs adjacent to the target tumor allows a high dose to be delivered to the tumor, thus potentially increasing the efficacy of radiation treatment. Currently, radiosurgery is commonly used for brain metastases, Stage I lung cancer, spine tumors, and localized prostate cancer. The purpose of this protocol is to evaluate the role of Radiosurgery for the treatment of clinically localized primary renal cell carcinoma.

Conditions

Renal Cell Carcinoma

Keywords

Renal Cell Carcinoma; Cyberknife

Outcome Measures

Primary Outcomes (1)

• To determine the freedom from local tumor progression in patients treated with CyberKnife radiosurgery for primary renal tumors at 6 months

  To determine the freedom from local tumor progression in patients treated with CyberKnife radiosurgery for primary renal tumors at 6 months

  2 Years

Secondary Outcomes (2)

• To determine impact of therapy on quality of life.

  2 Years

• To evaluate adverse events.

  2 years

Study Arms (1)

Cyberknife

EXPERIMENTAL

You will receive a series of Cyberknife Radiosurgery treatments, with the amount of radiation dosing adjusted for the size of your tumor. The treatment will ideally take place over the course of 3-4 days, but not more than 14 days overall. (3 or 4 fractions of radiation therapy delivered by cyberknife)

Device: CyberKnife

Interventions

CyberKnife DEVICE

Stereotactic Body Radiation Therapy. 3 or 4 fractions of radiotherapy delivered by Cyberknife.

Also known as: SBRT

Cyberknife

Eligibility Criteria

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

You may qualify if:

• Participants must meet the following criteria on screening examination to be eligible to participate in the study:
• Participants must have histologically or radiological evidence of Stage I (T1N0M0) renal cell carcinoma with a size no larger than 8 cm in greatest dimension measured by MRI or CT Scan
• At least one (usually up to 3) gold fiducial placed in or around tumor, can be performed on the same day - after signing research informed consent.
• No irreversible coagulopathies
• Age ≥ 18 years old because no dosing or adverse event data are currently available on the use of Cyberknife Radiosurgery radiation in participants \<18 years of age, children are excluded from this study but will be eligible for future pediatric Phase II trials.
• ECOG Performance Status ≤2 (Appendix A).
• At least 12 month life expectancy
• Ability to have CT and/or MRI imaging with or without contrast and must be performed within 120 days prior to registration.
• No other cancer in previous 2 years with the exception of non-invasive skin cancers
• All subjects meeting eligibility criteria irrespective of gender, minority or other underrepresented status will be eligible for enrollment into the study.
• The effects of Cyberknife Radiosurgery on the developing human fetus are unknown. For this reason and because Radiation is known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Ability to understand and the willingness to sign a written informed consent document and study specific consent form prior to study entry.
• Labs: Serum Creatinin \<3 mg/dl, Urinalysis, INR \<2, PTT \<70 sec, AST, ALT ≤2.5x ULN, Abnormalities on urinalysis (i.e. proteinuria) will not exclude patients from participation on study.

You may not qualify if:

• Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
• Irreversible coagulopathies that preclude fiducial placement
• Prior upper abdominal external beam irradiation
• Prior history of invasive malignancy within the last 2 years
• Inability to deliver target dose with CyberKnife due to inability to image fiducials
• Inability to deliver target dose with CyberKnife due to normal tissue dose constraints
• Inability to have contrast CT or MRI to help define tumor volume for radiation planning
• Decreased platelet count and / or anticoagulation parameters that would preclude transcutaneous placement of fiducials

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Dana-Farber Cancer Institute: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

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

• Irving D Kaplan, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irving D Kaplan, MD

CONTACT

617-667-2345; ikaplan@caregroup.harvard.edu

Kaitlyn Scott-Haughey, M.Ed

CONTACT

617-975-7408; kmscotth@bidmc.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Cyberknife treatment

Study Record Dates

• First Submitted: June 27, 2013
• First Posted: July 2, 2013
• Study Start: July 1, 2013
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)