Clinical trial NCT01600040: 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
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Cancer
Cervical Cancer
Keywords: metastatic
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-05-16
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: Dosimetric Comparison of Proton Beam Treatment With 3-dimensional Conformal Radiation Therapy (3DCRT) and Intensity Modulated Radiation Therapy (IMRT)
timeFrame: 5 years
measure: Acute Radiation Side Effects
timeFrame: 10 weeks
measure: Delayed Radiation Complications
timeFrame: 5 years
Secondary outcomes:
measure: Quality of Life (QOL)
timeFrame: Baseline, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years
measure: Progression-free Survival (PFS)
timeFrame: 12 months, 24 months, 36 months, 48 months, and 60 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Andrea Russo, MD
role: PRINCIPAL_INVESTIGATOR
References: