Proton Beam Radiation Therapy in Treating Patients with Uterine or Cervical Cancer with Regional Lymph Node Metastases

Inclusion Criteria

• Participants must have histologically confirmed primary cancer of the uterus or cervix with histologically confirmed metastasis to one or more parametrial, pelvic, or para-aortic nodes prior to enrollment; participants diagnosed at other institutions must have pathology reviewed and confirmed at Massachusetts General Hospital (MGH) or another Dana-Farber (DF)/Harvard Cancer Center (HCC) institution
• Uterine cancer participants will be International Federation of Gynecology and Obstetrics (FIGO) stage IIIC and may have endometrioid cancer, clear cell cancer, uterine papillary serous cancer, carcinosarcoma, or endometrial stromal sarcoma
• Cervical cancer participants will be American Joint Cancer Commission (AJCC) stages pT1 ,2, N1, M0 with squamous carcinoma, adenocarcinoma, adenosquamous carcinoma, or glassy cell carcinoma histology
• Participants must have undergone simple, modified radical, or radical abdominal hysterectomy or vaginal hysterectomy and lymphadenectomy (pelvic nodes, para-aortic nodes, or both nodal basins) by open or laparoscopic assisted technique
• Participants may have undergone prior chemotherapy for their uterine malignancy or may undergo chemotherapy in conjunction with adjuvant proton therapy per discretion of treating physicians; the agents, doses, routes and schedule of administration will be determined by their attending gynecologic oncologist or medical oncologist; for participants who have undergone prior chemotherapy, protocol radiation may commence no sooner than 21 days after the last chemotherapy treatment
• Participants with cervical cancer may undergo chemotherapy in conjunction with adjuvant proton therapy; the agents, doses, routes and schedule of administration will be determined by their attending gynecologic oncologist or medical oncologist
• Prior therapeutic radiation exposure to tissues for which protocol irradiation is anticipated is an exclusion criterion
• There will be no upper age limit for eligibility; elderly patients will be eligible for participation provided they are competent to provide informed consent, or written consent can be provided by their duly appointed healthcare proxy
• Life expectancy of greater than 18 months
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
• Baseline hematology laboratories will be performed prior to registration, the patient can be enrolled in the trial if laboratory values are deemed clinically acceptable by treating physician
• Participants must have no clinical, radiographic, or laboratory evidence of cancer dissemination to the peritoneal cavity, chest cavity, or spread via hematogenous dissemination; computed tomography (CT) or positron emission tomography (PET)/CT of the chest, abdomen and pelvis must have been obtained within 10 weeks of study entry; there must be no measurable (macroscopic) disease within the radiation target volume following hysterectomy and lymphadenectomy
• Participants must have the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

• Inability to sign informed consent document
• Evidence of extra-abdominal cancer dissemination or hematogenous cancer dissemination
• Evidence of measurable (macroscopic) residual disease following hysterectomy and lymphadenectomy
• Prior therapeutic radiation to target tissues for protocol radiation
• Individuals with a history of a different malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years or are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals 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