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

Status: Recruiting
Phase: N/A
Diagnosis: GYN: Endometrial/Uterine Cancer, GYN: Cervical Cancer
NCT ID: NCT01600040 (View complete trial on
DFCI Protocol ID: 10-269


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).


Conducting Institutions:
Massachusetts General Hospital

Overall PI:
Anthony Russell, MD, Massachusetts General Hospital

Site-responsible Investigators:

Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

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
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