Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT01890590

A Phase II Study of Cyberknife Radiosurgery for Renal Cell Carcinoma

Led by Beth Israel Deaconess Medical Center · Updated on 2024-08-15

46

Participants Needed

1

Research Sites

608 weeks

Total Duration

On this page

Sponsors

B

Beth Israel Deaconess Medical Center

Lead Sponsor

D

Dana-Farber Cancer Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

A Phase II Study of Cyberknife Radiosurgery for Renal Cell Carcinoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants 18 years or older
  • Histological or radiological evidence of Stage I (T1N0M0) renal cell carcinoma with tumor size no larger than 8 cm measured by MRI or CT scan
  • At least one gold fiducial marker placed in or around the tumor
  • No irreversible coagulopathies
  • ECOG Performance Status 0, 1, or 2
  • Life expectancy of at least 12 months
  • Ability to undergo CT and/or MRI imaging within 120 days prior to registration
  • No other cancer diagnosis in the previous 2 years except non-invasive skin cancers
  • Agreement to use effective contraception if of child-bearing potential during study participation
  • Ability to understand and sign informed consent
  • Laboratory values within specified limits (Serum Creatinine <3 mg/dl, INR <2, PTT <70 sec, AST and ALT ≤2.5 times upper limit normal)
Not Eligible

You will not qualify if you...

  • Irreversible coagulopathies preventing fiducial placement
  • Prior upper abdominal external beam radiation therapy
  • History of invasive malignancy within the last 2 years
  • Inability to deliver target radiation dose due to imaging or tissue constraints
  • Inability to undergo contrast CT or MRI for tumor volume definition
  • Low platelet count or anticoagulation issues precluding fiducial placement

AI-Screening

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Trial Site Locations

Total: 1 location

1

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Actively Recruiting

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Research Team

I

Irving D Kaplan, MD

CONTACT

K

Kaitlyn Scott-Haughey, M.Ed

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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