Carcinoma of the Vulva, Cervical Cancer, Uterine Cancer, Vaginal Cancer
Conditions
Keywords
Brachytherapy, Gynecological cancer
Brief summary
Standard therapy for gynecologic cancers involves the use of brachytherapy, also called internal radiation therapy or implant radiation. The treatment being studied consists of standard brachytherapy with the additional use of MRI to guide the insertion of radioactive applicators. The purpose of the study is to find out whether MRI-guided brachytherapy is practical and beneficial when compared to the standard CT-guided brachytherapy placement. The investigators are hoping that this MRI procedure will decrease the risk of giving too high a radiation dose to the bladder or bowel.
Detailed description
The insertion of the brachytherapy applicator will be administered in the Advanced Multimodality Image-Guided Operating (AMIGO) suite at Brigham and Women's Hospital. Subjects will undergo an MRI scan in the AMIGO suite ensuring proper placement of the applicator. Subjects may have an optional FMISO-PET scan. Subjects will have a follow-up visit including physical exam, pap smear, and MRI of the pelvis and/or PET scan 90 days after treatment. Subjects will have a follow-up visit including physical exam, pap smear, and MRI of the pelvis and/or PET scan 180 days after treatment.
Interventions
PROCEDUREImage-guided brachytherapy
MRI-guided application of brachytherapy
Assessing tumor proliferation in Gynecologic cancer
Sponsors
Dana-Farber Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed carcinoma of the cervix (Stage I-IVA), carcinoma of the uterus (Stage IIIB), carcinoma of the vagina (Stage I-IVA), or carcinoma of the vulva (stage I-IVA) * Life expectancy \> 6 months * MRI of the pelvis and/or PET-CT within 4 months prior to entering study
Exclusion criteria
* Uncontrolled intercurrent illness * Pacemaker, brain aneurysm clip, inner ear implant, neurostimulator, or metal fragments in the eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Doses Given | Measured while on treatment, up to 2 months. | Doses given to the tumor, rectum, and sigmoid obtained after AMIGO-guided placement. |
Countries
United States
Participant flow
Recruitment details
September 2011 to February 2016
Participants by arm
| Arm | Count |
|---|---|
| Image-Guided Brachytherapy Image-guided brachytherapy
Image-guided brachytherapy: MRI-guided application of brachytherapy
3'-Deoxy-3'-18f-Fluorothymidine: Assessing tumor proliferation in Gynecologic cancer | 93 |
| Total | 93 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Alternative therapy | 1 |
| Overall Study | Ineligible | 1 |
| Overall Study | Machine Technical Issue | 3 |
| Overall Study | No reason given | 1 |
Baseline characteristics
| Characteristic | Image-Guided Brachytherapy |
|---|---|
| Age, Continuous | 60 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 65 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 25 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 20 Participants |
| Race (NIH/OMB) White | 64 Participants |
| Sex: Female, Male Female | 93 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 86 / 93 |
| serious Total, serious adverse events | 0 / 93 |
Outcome results
Primary
Mean Doses Given
Doses given to the tumor, rectum, and sigmoid obtained after AMIGO-guided placement.
Time frame: Measured while on treatment, up to 2 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Image-Guided Brachytherapy | Mean Doses Given | Tumor | 93.9 Gy | Standard Deviation 8.59 |
| Image-Guided Brachytherapy | Mean Doses Given | Rectum | 63.2 Gy | Standard Deviation 9.04 |
| Image-Guided Brachytherapy | Mean Doses Given | Sigmoid | 58.63 Gy | Standard Deviation 12.05 |