Proton Beam Teletherapy for Post-Hysterectomy Cancers of the Uterus and Cervix

Description

Proton beam radiation therapy is known to spare surrounding normal tissues from radiation. Proton beam radiation delivers less radiation beyond the area of the target tissues. This may reduce side effects that patients would normally experience with standard (photon) radiation therapy which tends to unavoidably include more normal tissue along with tumor target tissue. In this research study, the investigators are looking to determine if proton beam radiation is effective in controlling your cancer growth. The investigators are also looking to see if proton beam radiation can reduce side effects when compared to standard radiation treatment (photon radiation).

Study Start Date

May 2013

Estimated Completion Date

May 2019

Interventions

  • Radiation: Proton beam therapy
  • Radiation: Proton radiation therapy

Specialties

  • Obstetrics & Gynecology: Gynecologic Oncology
  • Oncology: Gynecologic Oncology

MeSH Terms

  • Cervical Cancer
  • Proton beam therapy
  • Uterine Cancer

Study ID

Massachusetts General Hospital -- 10-269

Status

Unknown

Trial ID

NCT01600040

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

30

Sponsor

Massachusetts General Hospital

Inclusion Criteria

  • Histologically confirmed primary cancer of the uterus or cervix
  • Have undergone simple, modified radical, or radical abdominal hysterectomy or vaginal hysterectomy and lymphadenectomy by open or laparoscopic assisted technique
  • Life expectancy greater than 18 months
  • Adequate organ and bone marrow function

Exclusion Criteria

  • Prior therapeutic radiation exposure to target tissues for protocol radiation
  • Evidence of extra-abdominal cancer dissemination or hematogenous cancer dissemination
  • Evidence of measurable residual disease following hysterectomy and lymphadenectomy
  • History of a different malignancy except if disease-free for at least 5 years and are deemed by the investigator ro be at low risk for recurrence of that malignancy. Subjects with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (2)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles None None None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Karen De Amorim Bernstein MD None kbernstein2@partners.org

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