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

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 with histologically
confirmed metastasis to one or more parametrial, pelvic or paraaortic nodes prior to
enrollment. Subjects diagnosed at other institutions must have pathology reviewed and
confirmed at MGH or another DF/HCC institution

- 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

- Uterine cancer subjects will be FIGO stage IIIC and may have endometrioid cancer,
clear cell cancer, uterine papillary serous cancer, carcinosarcoma, or endometrial
stromal sarcoma

- Cervical cancer subjects will be AJCC stages pT1,2,N1,M0 with squamous carcinoma,
adenocarcinoma, adenosquamous carcinoma, or glassy cell carcinoma histology

- ECOG performance status ≤ 2 or Karnofsky performance status ≥ 60%

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