Trial record 2 of 363 for:    Open Studies | "Uterine Neoplasms"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Massachusetts General Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Karen De Amorim Bernstein, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01600040
First received: May 14, 2012
Last updated: October 8, 2013
Last verified: October 2013
  Purpose

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 Intervention
Uterine Cancer
Cervical Cancer
Radiation: Proton radiation therapy

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Magnitude of radiation dose reductions [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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:
  • QOL [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    To determine the progression-free survival and patterns of recurrence with this treatment.


Estimated Enrollment: 30
Study Start Date: May 2013
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed primary cancer of the uterus or cervix
  • 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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01600040

Contacts
Contact: Karen De Amorim Bernstein, MD kbernstein2@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Karen De Amorim Bernstein, MD       kbernstein2@partners.org   
Principal Investigator: Karen De Amorim Bernstein, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Karen De Amorim Bernstein, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Karen De Amorim Bernstein, MD, Radiation Oncologist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01600040     History of Changes
Other Study ID Numbers: 10-269
Study First Received: May 14, 2012
Last Updated: October 8, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Massachusetts General Hospital:
metastatic

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

ClinicalTrials.gov processed this record on August 28, 2014