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

NCT03206385 | Unknown

• 1 other identifier: CK Boost Pelvis
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvis Tumors

Outcome Measures

Primary Outcomes (1)

• 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 (3)

• Local clinical control rates

  follow up during 3 years after patient inclusion

• Extra pelvic dissemination rates

  follow up during 3 years after patient inclusion

• Ability of the multi leaf collimator to better cover the PTVs and to help shortening the delivery times

  follow up during 3 years after patient inclusion

Study Arms (1)

CK Boost pelvis

Radiation: Radiation treatment; Radiation: CK Boost Pelvis

Interventions

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.

CK Boost pelvis

CK Boost Pelvis 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

CK Boost pelvis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Francois Baclesse, Luxembourg: lead

Study Sites (1)

Centre Francois Baclesse

Esch-sur-Alzette, SUD, L-4240, Luxembourg

Location

MeSH Terms

Conditions

Pelvic Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 2, 2017
• Study Start: May 31, 2017
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 22, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

LU (1)