NCT01600040

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
RADIATION	Proton radiation therapy	5 days per week (Mon-Fri) for 5-6 weeks

Timeline

• Start date: 2013-08-01
• Primary completion: 2022-10-19
• Completion: 2023-08-10
• First posted: 2012-05-16
• Last updated: 2024-10-29
• Results posted: 2024-10-29

Locations

1 site across 1 country: United States