Clinical trial · Observational
IMRT Followed by CyberKnife Boost Focused on the Gross Residual Pelvic Tumor Volume
Intensity Modulated Radiation Treatments Followed by A Stereotactic CyberKnife Boost Focused on the Gross Residual Pelvic Tumor Volume
NCT03206385CI-TRIAL-00059217Boost_PelvisunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The present register has been designed to confirm the hypothesis that while using high quality Intensity Modulated Radiation Techniques (IMRT) and a reduced external beam stereotactic boost component it would be possible to maintain the late severe toxicity rates under the 5 % level in situations where brachytherapy could not be proposed as a boost.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pelvis Tumors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CK Boost Pelvis | Radiation | — | UNRESOLVED |
| Radiation treatment | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- CK Boost pelvis
- interventionNames
- Radiation: Radiation treatment
- Radiation: CK Boost Pelvis
Primary outcomes (1)
- measure
- Severe toxicity
- timeFrame
- follow up during 3 years after patient inclusion
- description
- The objective is to confirm an expected toxicity level of severe toxicity \< 5%
Secondary outcomes (3)
- measure
- Local clinical control rates
- timeFrame
- follow up during 3 years after patient inclusion
- description
- Ths objective is to study the local control rates defined by a study panel board including at least a radiologist specially trained to review the imaging data after high radiation doses per fraction and the coordinator of the register, using PET Scanner, MRI and clinical data
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * any kind of locally advanced pelvic tumor, non-operable for any reason * signed informed consent * concomitant chemotherapy or hormonotherapy unless gemcitabine will not be contraindicated during the treatment Exclusion Criteria: * possibility to easily offer the patient a brachytherapy boost * extra pelvic tumor dissemination above the L3 vertebra * collagenoses * any bowel tumor when the digestive tract is not definitely and locally bypassed * any biologic targeted therapy or anti angiogenic therapy within the 6 weeks preceding the initiation of the radiation treatment, for the first 20 patients. This point will be revisited afterwards and will conduct to an amendment in case of protocol modification * gemcitabine chemotherapy within the 6 weeks preceding the initiation of the radiation treatment or during the treatment * hip prostheses
References
Publications (0)
Data not yet available
No reference posted for this study.