Proton Beam Teletherapy for Post-Hysterectomy Cancers of the Uterus and Cervix
Conditions
Uterine Cancer - Cervical Cancer
Conditions: official terms
Uterine Cervical Neoplasms - Uterine Neoplasms
Conditions: Keywords
metastatic
Study Type
Interventional
Study Phase
N/A
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Proton radiation therapy
Type: Radiation
Overall Status
Recruiting
Summary
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).
Detailed Description
Subjects will receive proton beam radiation treatment as an outpatient at the Francis H. Burr Proton Center at Massachusetts General Hospital, 5 days per week (Mon-Fri) over 5-6 weeks depending on the type of cancer.

Tests and procedures during study treatment (weekly):

- Questions about health and current medications

- Physical exam, includes height, weight and vital signs

- Performance status

- Blood test for complete blood counts and blood clotting (2 tsps). Repeated twice weekly for uterine cancer subjects and once weekly for cervix cancer subjects

- Pelvic exam (at week 6 only)

- Quality of life questionnaires

After completion of proton beam radiation treatment, subjects will be followed for 5 years. Follow-up visits will occur every 3 months for 2 years; every 4 months to year 3 and every 6 months thereafter. At each visit subjects will receive:

- A medical history

- Physical exam

- Performance status

- Pelvic exam

- CT scan of the chest, abdomen and pelvis every 6 months to year 3

- Quality of life questionnaires (6, 12, 24, 36, 48, and 60 months)
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: 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
Location
Massachusetts General Hospital
Boston, Massachusetts, United States
Status: Recruiting
Contact: Karen De Amorim Bernstein, MD - kbernstein2@partners.org
Start Date
May 2013
Sponsors
Massachusetts General Hospital
Source
Massachusetts General Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page