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

Brief Summary:

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).

Condition or disease Intervention/treatment Phase
Uterine Cancer Cervical Cancer Radiation: Proton radiation therapy Not Applicable

Detailed Description:

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)

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Adjuvant Proton Beam Teletherapy for Post-Hysterectomy Cancers of the Uterus and Cervix With Metastases to Regional Lymph Nodes
Study Start Date : May 2013
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Proton Radiation Therapy
This is a single arm study; all participants will receive proton radiation therapy.
Radiation: Proton radiation therapy
5 days per week (Mon-Fri) for 5-6 weeks

Primary Outcome Measures :
  1. 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).

  2. 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.)

Secondary Outcome Measures :
  1. 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.

  2. Progression-free survival [ Time Frame: 5 years ]
    To determine the progression-free survival and patterns of recurrence with this treatment.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01600040

Contact: Karen De Amorim Bernstein, MD

United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Karen De Amorim Bernstein, MD   
Principal Investigator: Karen De Amorim Bernstein, MD         
Sponsors and Collaborators
Massachusetts General Hospital
National Cancer Institute (NCI)
Principal Investigator: Karen De Amorim Bernstein, MD Massachusetts General Hospital

Responsible Party: Karen De Amorim Bernstein, MD, Radiation Oncologist, Massachusetts General Hospital Identifier: NCT01600040     History of Changes
Other Study ID Numbers: 10-269
First Posted: May 16, 2012    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018

Keywords provided by Karen De Amorim Bernstein, MD, Massachusetts General Hospital:

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female