IMRT Followed by CyberKnife Boost Focused on the Gross Re... | NCT03206385

Studies
IMRT Followed by CyberKnife Boost Focused on the Gross Residual Pelvic Tumor Volume

NCT03206385

Sponsor

Centre Francois Baclesse, Luxembourg

Status

Unknown status

Last Update Posted

Jun 22, 2022Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Pelvis Tumors

Interventions

Radiation treatment
CK Boost Pelvis

Countries

Luxembourg

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 31, 2017Actual

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Jun 30, 2017

First Submission Date that Met QC Criteria

Jun 30, 2017

First Posted Date

Jul 2, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2022

Last Update Posted Date

Jun 22, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Placement of fiducials First of all, fiducials will be placed near or inside the Gross Tumor Volume (GTV).
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.
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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CK Boost pelvis			Radiation: Radiation treatment Radiation: CK Boost Pelvis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Radiation treatment	Radiation	50 Gy will be delivered in the 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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Severe toxicity	The objective is to confirm an expected toxicity level of severe toxicity < 5%	follow up during 3 years after patient inclusion

Secondary Outcomes

Measure	Description	Time Frame
Local clinical control rates	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	follow up during 3 years after patient inclusion

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with any kind of non-resected pelvic cancer for which a brachytherapy Gross Tumor Volume (GTV) boost is non indicated

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Centre Francois Baclesse		Esch-sur-Alzette	SUD	L-4240	Luxembourg

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms