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

Primary Purpose

Uterine Cancer, Cervical Cancer

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Proton radiation therapy

About this trial

This is an interventional treatment trial for Uterine Cancer focused on measuring metastatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Proton Radiation Therapy

Arm Description

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

Outcomes

Primary Outcome Measures

Magnitude of radiation dose reductions

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

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

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

To determine the progression-free survival and patterns of recurrence with this treatment.

Full Information

NCT ID

NCT01600040

First Posted

May 14, 2012

Last Updated

January 12, 2021

Sponsor

Massachusetts General Hospital

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT01600040

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Unknown status

Study Start Date

May 2013 (undefined)

Primary Completion Date

September 2023 (Anticipated)

Study Completion Date

September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Uterine Cancer, Cervical Cancer

Keywords

metastatic

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Proton Radiation Therapy

Arm Type

Other

Arm Description

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

Intervention Type

Radiation

Intervention Name(s)

Proton radiation therapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Magnitude of radiation dose reductions

Description

Time Frame

5 years

Title

Radiation side effects and delayed complications

Description

Time Frame

5 years

Secondary Outcome Measure Information:

Title

QOL

Description

Time Frame

5 years

Title

Progression-free survival

Description

To determine the progression-free survival and patterns of recurrence with this treatment.

Time Frame

5 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrea Russo, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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