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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01600040
Recruitment Status : Recruiting
First Posted : May 16, 2012
Last Update Posted : May 7, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Karen De Amorim Bernstein, MD, Massachusetts General Hospital

May 14, 2012
May 16, 2012
May 7, 2018
May 2013
May 2019   (Final data collection date for primary outcome measure)
  • Magnitude of radiation dose reductions [ Time Frame: 5 years ]
    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).
  • Radiation side effects and delayed complications [ Time Frame: 5 years ]
    To prospectively assess acute radiation side effects and delayed complications in proton treated patients and to compare toxicity outcomes (acute side effects and delayed complications) with patients historically treated with photon teletherapy using institutional historical controls. (Retrospective outcomes comparison study.)
Same as current
Complete list of historical versions of study NCT01600040 on Archive Site
  • QOL [ Time Frame: 5 years ]
    To prospectively collect data on quality of life (QOL) before and after adjuvant scanning proton beam therapy employing contemporary, validated instruments tailored for women treated for gynecologic cancer.
  • Progression-free survival [ Time Frame: 5 years ]
    To determine the progression-free survival and patterns of recurrence with this treatment.
Same as current
Not Provided
Not Provided
Proton Beam Teletherapy for Post-Hysterectomy Cancers of the Uterus and Cervix
Pilot Study of Adjuvant Proton Beam Teletherapy for Post-Hysterectomy Cancers of the Uterus and Cervix With Metastases to Regional Lymph Nodes

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).

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)
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Uterine Cancer
  • Cervical Cancer
Radiation: Proton radiation therapy
5 days per week (Mon-Fri) for 5-6 weeks
Proton Radiation Therapy
This is a single arm study; all participants will receive proton radiation therapy.
Intervention: Radiation: Proton radiation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
May 2021
May 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact: Karen De Amorim Bernstein, MD
United States
Not Provided
Not Provided
Karen De Amorim Bernstein, MD, Massachusetts General Hospital
Massachusetts General Hospital
National Cancer Institute (NCI)
Principal Investigator: Karen De Amorim Bernstein, MD Massachusetts General Hospital
Massachusetts General Hospital
May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP