Trial Outcomes & Findings for Magnetic Resonance Imaging-Based Radiation Therapy and Cisplatin in Patients With Stage I, Stage II, Stage III, or Stage IV Cervical Cancer (NCT NCT01016561)
NCT ID: NCT01016561
Last Updated: 2021-05-05
Results Overview
Feasibility will be defined if no greater than 10% of patients experience one of the following events: a) patient is unable to tolerate 50% of MRI-based brachytherapy treatments and b) patient experiences any grade 4 acute ("early") non-hematologic toxicity attributed to brachytherapy. Acute toxicity occurs within 60 days of therapy.
TERMINATED
NA
12 participants
Completion of study
2021-05-05
Participant Flow
Participant milestones
| Measure |
Arm I
Patients undergo external beam radiotherapy (3-dimensional conformal OR intensity-modulated) and 4-6 insertions of MRI-guided intracavitary brachytherapy over 8 weeks. Patients also receive cisplatin IV over 30-60 minutes for 5-6 weeks during radiotherapy.
intracavitary balloon brachytherapy
external beam radiation therapy
intensity-modulated radiation therapy
radiation therapy treatment planning/simulation
3-dimensional conformal radiation therapy
Cisplatin
|
|---|---|
|
Overall Study
STARTED
|
0
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Magnetic Resonance Imaging-Based Radiation Therapy and Cisplatin in Patients With Stage I, Stage II, Stage III, or Stage IV Cervical Cancer
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Completion of studyPopulation: he study was terminated and the PI has left the institution. Despite all possible efforts to contact the PI/study team members, no data are available to be reported
Feasibility will be defined if no greater than 10% of patients experience one of the following events: a) patient is unable to tolerate 50% of MRI-based brachytherapy treatments and b) patient experiences any grade 4 acute ("early") non-hematologic toxicity attributed to brachytherapy. Acute toxicity occurs within 60 days of therapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 days post treatmentPopulation: he study was terminated and the PI has left the institution. Despite all possible efforts to contact the PI/study team members, no data are available to be reported
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time to local recurrencePopulation: he study was terminated and the PI has left the institution. Despite all possible efforts to contact the PI/study team members, no data are available to be reported
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time to loco-regional recurrencePopulation: he study was terminated and the PI has left the institution. Despite all possible efforts to contact the PI/study team members, no data are available to be reported
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time to recurrencePopulation: he study was terminated and the PI has left the institution. Despite all possible efforts to contact the PI/study team members, no data are available to be reported
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time to deathPopulation: Not enough patients were accrued to the study for analysis.
Outcome measures
Outcome data not reported
Adverse Events
Arm I
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place