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

NCT ID: NCT03206385

Last Updated: 2022-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-31
• Study Completion Date: 2023-12-31

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.

Conditions

Pelvis Tumors

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

CK Boost pelvis

Radiation treatment

Intervention Type: 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.

CK Boost Pelvis

Intervention Type: RADIATION

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 OAR

Interventions

Radiation treatment

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.

Intervention Type: RADIATION

CK Boost Pelvis

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 OAR

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Francois Baclesse, Luxembourg

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Francois Baclesse

Esch-sur-Alzette, SUD, Luxembourg

Countries

Luxembourg

Other Identifiers

CK Boost Pelvis

Identifier Type: -

Identifier Source: org_study_id