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

NCT ID: NCT01600040

Last Updated: 2024-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2023-08-10

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).

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)

Conditions

Uterine Cancer; Cervical Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Proton Radiation Therapy

This is a single arm study; all participants will receive proton radiation therapy.

Group Type: OTHER

Proton radiation therapy

Intervention Type: RADIATION

5 days per week (Mon-Fri) for 5-6 weeks

Interventions

Proton radiation therapy

5 days per week (Mon-Fri) for 5-6 weeks

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Andrea Russo, MD

Director, Gynecologic Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Russo, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

10-269

Identifier Type: -

Identifier Source: org_study_id