Pilot Study of Adjuvant Proton Beam Teletherapy for Post-Hysterectomy Cancers of the Uterus and Cervix With Metastases to Regional Lymph Nodes
18 Years
N/A
Female
Uterine Cancer, Cervical Cancer
Trial Information
Pilot Study of Adjuvant Proton Beam Teletherapy for Post-Hysterectomy Cancers of the Uterus and Cervix With Metastases to Regional Lymph Nodes
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)
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Magnitude of radiation dose reductions
Outcome Description:
In a population of women with cancers of the cervix or endometrium with pathologically proven spread to regional lymph nodes, to quantitate the magnitude of the normal tissue radiation dose reductions achieved by comparison of dose volume histograms achieved by scanning proton beam teletherapy with dose volume histograms of treatment plans for the same patients using 3-dimensional conformal radiation therapy (3DCRT) and intensity modulated radiation therapy (IMRT).
Outcome Time Frame:
5 years
Safety Issue:
Yes
Principal Investigator
Anthony H Russell, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Massachusetts General Hospital
Authority:
United States: Institutional Review Board
Study ID:
10-269
NCT ID:
NCT01600040
Start Date:
May 2013
Completion Date:
Related Keywords:
- Uterine Cancer
- Cervical Cancer
- metastatic
- Uterine Cervical Neoplasms
- Uterine Neoplasms
Name | Location |
|---|---|
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
