TriangleNCT00331760 · OUTCOME
Reproducibility of Radiation Technique (Number of Unacceptable Deviations in Central IMRT Quality Assurance Review)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- IMRT planning and dosing data is centrally reviewed for quality assurance after treatment delivery.
What was measured
Central quality assurance review of the IMRT planning and dosing categorized unacceptable deviations (UD) from protocol compliance with the delineation of planning target volume for the vagina and pelvic lymph nodes. Each arm of this study is considered independently, they are not compared to each other. The study was designed such that, for each arm, 5 or more of 42 subjects scored as unacceptable would determine the respective treatment technique as not reproducible. For each arm this design provides 90% power with a 0.05 type I error to reject the null hypothesis that the true probability of concluding the given technique to be reproducible is \<= 80%. The alternative hypothesis is that the true probability is \>= 95%. For \[vagina / pelvic lymph nodes\]: UD is defined as: The 90% isodose surface covers \< 95% of \[internal target volume (ITV)/ planned target volume (PTV)\] 50.4 or \> 5% of the \[ITV/PTV\] 50.4 receives over 115%.
Analysis population: All eligible patients.
Groups in this outcome
Endometrial Cancer: IMRT
Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
| Group | Source count |
|---|---|
| Endometrial Cancer: IMRT | 43 |
| Cervical Cancer: IMRT + Chemotherapy (Cisplatin) | 40 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Endometrial Cancer: IMRT | 1 | Not reported | Not reported | Not reported | Not reported |
| Cervical Cancer: IMRT + Chemotherapy (Cisplatin) | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 43
- group Id
- OG001
- value
- 40
- units
- Participants
- description
- Central quality assurance review of the IMRT planning and dosing categorized unacceptable deviations (UD) from protocol compliance with the delineation of planning target volume for the vagina and pelvic lymph nodes. Each arm of this study is considered independently, they are not compared to each other. The study was designed such that, for each arm, 5 or more of 42 subjects scored as unacceptable would determine the respective treatment technique as not reproducible. For each arm this design provides 90% power with a 0.05 type I error to reject the null hypothesis that the true probability of concluding the given technique to be reproducible is \<= 80%. The alternative hypothesis is that the true probability is \>= 95%. For \[vagina / pelvic lymph nodes\]: UD is defined as: The 90% isodose surface covers \< 95% of \[internal target volume (ITV)/ planned target volume (PTV)\] 50.4 or \> 5% of the \[ITV/PTV\] 50.4 receives over 115%.
- groups
- description
- Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
- id
- OG000
- title
- Endometrial Cancer: IMRT
- description
- Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
- id
- OG001
- title
- Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
- param Type
- NUMBER
- population Description
- All eligible patients.
- reporting Status
- POSTED
- time Frame
- IMRT planning and dosing data is centrally reviewed for quality assurance after treatment delivery.
- title
- Reproducibility of Radiation Technique (Number of Unacceptable Deviations in Central IMRT Quality Assurance Review)
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice