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

Not Applicable

Completed

Conditions: Cervical Cancer
Uterine Cancer

Interventions: Radiation: Proton radiation therapy

Registration Number: NCT01600040

Lead Sponsor: Massachusetts General Hospital

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)

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 22

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Proton Radiation Therapy	Proton radiation therapy	This is a single arm study; all participants will receive proton radiation therapy.

Primary Outcome Measures

Name	Time	Method
Dosimetric Comparison of Proton Beam Treatment With 3-dimensional Conformal Radiation Therapy (3DCRT) and Intensity Modulated Radiation Therapy (IMRT)	5 years	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.
Acute Radiation Side Effects	10 weeks	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).
Delayed Radiation Complications	5 years	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).

Secondary Outcome Measures

Name	Time	Method
Quality of Life (QOL)	Baseline, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years	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
Progression-free Survival (PFS)	12 months, 24 months, 36 months, 48 months, and 60 months	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.