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).

Study Overview

• Status: Completed
• Conditions: Cervical Cancer; Uterine Cancer
• Intervention / Treatment: Radiation: Proton radiation therapy

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
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dosimetric Comparison of Proton Beam Treatment With 3-dimensional Conformal Radiation Therapy (3DCRT) and Intensity Modulated Radiation Therapy (IMRT)	In a population of women with cancers of the cervix or endometrium with pathologically proven spread to regional lymph nodes, dose volume histograms (DVH) were compared between scanning proton beam teletherapy, 3-dimensional conformal radiation therapy (3DCRT) and intensity modulated radiation therapy (IMRT). Structure sets contoured for the proton beam therapy delivered on study were used to plan alternative 3DCRT and IMRT plans by the the same medical physics team (3DCRT and IMRT were not used on study; actual dose for proton beam was compared to the doses that would have been delivered for 3DCRT or IMRT.) Median, 25th percentile, and 75th percentile doses are listed below by tissue volume irradiated (mL) or percentage irradiated (%) for each modality. Dose is measured in grays (Gy), which is defined as the absorption of one joule of radiation energy per kilogram of matter.	5 years
Acute Radiation Side Effects	Acute radiation side effects were prospectively assessed. Below are the treatment-related acute toxicities (adverse events possibly, probably, or definitely related to protocol treatment that started within 4 weeks of treatment completion) that occurred on study, along with the number of participants who experienced each event at a given severity (Grade 1/mild, Grade 2/moderate, Grade 3/severe) according to the CTCAE v 4.02 (Common terminology criteria for adverse events).	10 weeks
Delayed Radiation Complications	Delayed complications from radiation were prospectively assessed. Below are the treatment-related late toxicities (adverse events possibly, probably, or definitely related to protocol treatment that started 6 months or later after treatment completion) that occurred on study, along with the number of participants who experienced each event at a given severity (Grade 1/mild, Grade 2/moderate, Grade 3/severe) according to the CTCAE v 4.02 (Common terminology criteria for adverse events).	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life (QOL)	The total FACT-EN/Cx scale (Functional Assessment of Cancer Therapy - Endometrial/Cervical) score was assessed at baseline and timepoints of 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years to evaluate quality of life (QOL) before and after adjuvant scanning proton beam therapy. Unit = Scores on a scale. Subset scores are summed together to get a total score. Functional Assessment of Cancer Therapy - Endometrial - score range 0 - 172, with higher scores indicating a better outcome Functional Assessment of Cancer Therapy - Cervical - score range 0 - 168, with higher scores indicating a better outcome	Baseline, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years
Progression-free Survival (PFS)	PFS is defined as the duration of time from start of treatment to time of objective disease progression at any site as detected by symptomatic recurrence or routine surveillance follow-up physical examination/imaging, or death from any cause.	12 months, 24 months, 36 months, 48 months, and 60 months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Andrea Russo, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2013
• Primary Completion (Actual): October 19, 2022
• Study Completion (Actual): August 10, 2023

Study Registration Dates

• First Submitted: May 14, 2012
• First Submitted That Met QC Criteria: May 15, 2012
• First Posted (Estimated): May 16, 2012

Study Record Updates

• Last Update Posted (Actual): October 29, 2024
• Last Update Submitted That Met QC Criteria: October 26, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: metastatic
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Neoplasms
• Other Study ID Numbers: 10-269