Clinical trial NCT03206385: IMRT Followed by CyberKnife Boost Focused on the Gross Residual Pelvic Tumor Volume
Official title: Intensity Modulated Radiation Treatments Followed by A Stereotactic CyberKnife Boost Focused on the Gross Residual Pelvic Tumor Volume
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvis Tumors
Lead sponsor: Centre Francois Baclesse, Luxembourg
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with any kind of non-resected pelvic cancer for which a brachytherapy Gross Tumor Volume (GTV) boost is non indicated

Brief summary: 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.

Detailed description: This register concerned patients with any kind of non-resected pelvic cancer for which a brachytherapy Gross Tumor Volume (GTV) boost is non indicated.

1. Placement of fiducials First of all, fiducials will be placed near or inside the Gross Tumor Volume (GTV).
2. Radiation treatment The radiation treatment will be delivered by Varian Rapid ARC accelerators. 50 Gy will be delivered in the Planning Tumor Volume (PTV) 1 and 60 Gy in the PTV 2 simultaneously in 28 fractions (5 fractions a week) in no more than 40 days. Anytime, 95% of the prescribed dose will have to cover at least 90% of the PTV 1 and PTV 2.
3. CK Boost pelvis In the following 14 days after the external beam treatment, two high CyberKnife dose sessions will deliver a pelvic boost of 6.5 Gy each to the initial GTV or eventually to the residual GTV in case of too close vicinity of the organs at risk (OAR). This boost will be planned according to a recent paper, using a new CT scan and MRI scan for planimetric purposes. 95% of the prescribed dose will have to cover at least 90% of the PTV. The maximal CyberKnife tolerated doses to the OAR for a 6.5 Gy dose will be 5 Gy to 2cc of the bladder, rectum or sigmoid structures and 2.5 Gy to 5 cc of the small bowel. The protocol will not require a dose summation of the different steps of the treatment. The total duration of the whole treatment will have to be inferior to 55 days.

4 Follow-up The clinical follow up will be planed weekly during the radiation treatments, and at 2, 4 and 6 months thereafter. The patients will be then followed up every 4 months during the first 2 years and twice yearly thereafter.

A medical imaging using PET Scanner and MRI when possible will be performed at least at 6 months intervals during the first 2 years.

Eligibility criteria: 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

Primary outcomes:
measure: Severe toxicity
timeFrame: follow up during 3 years after patient inclusion
Secondary outcomes:
measure: Local clinical control rates
timeFrame: follow up during 3 years after patient inclusion
measure: Extra pelvic dissemination rates
timeFrame: follow up during 3 years after patient inclusion
measure: Ability of the multi leaf collimator to better cover the PTVs and to help shortening the delivery times
timeFrame: follow up during 3 years after patient inclusion
Other outcomes:
Locations:
city: Esch-sur-Alzette
country: Luxembourg
facility: Centre Francois Baclesse
state: SUD
Study officials:
References: