Simultaneous Integrated Boost (SIB)- IMRT | NCT00389727

Studies
Simultaneous Integrated Boost (SIB)- IMRT

NCT00389727

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status

Completed

Last Update Posted

Jul 15, 2019Actual

Enrollment

22Actual

Phase

Phase 2

Conditions

Carcinoma, Squamous Cell

Interventions

Radiotherapy

Countries

Belgium

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

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 24, 2004Actual

Primary Completion Date

May 26, 2008Actual

Completion Date

May 26, 2008Actual

First Submitted Date

Oct 18, 2006

First Submission Date that Met QC Criteria

Oct 18, 2006

First Posted Date

Oct 19, 2006Estimated

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

Jul 10, 2019

Last Update Posted Date

Jul 15, 2019Actual

Name	Class
Centre Georges Francois Leclerc	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 objective of the study is to assess the feasibility of increasing dose of irradiation with IMRT using a SIB approach over 6 weeks.

The primary endpoint of the study will be acute toxicity assessed during treatment and during the first 3 months following the completion of radiotherapy The secondary endpoint will include loco-regional control, disease-free survival, survival and late toxicity at 2 years after completion of radiotherapy

Detailed Description

Loco-regional failures remain a major concern following irradiation of locally advanced head and neck cancers. This has led radiation oncologists to investigate novel approaches offering better therapeutic indexes. Modification of dose fractionation schedules can improve the therapeutic outcome by using accelerated or hyperfractionated regimes -Ang, 1990; Ang, 1998; Fu, 2000; Gwozdz, 1997-. Intensity Modulated Radiation Therapy (IMRT) technique allows the planning and irradiation of different targets at different dose levels in a single treatment session, instead of successive treatment plans. With conventional 2D radiotherapy, both normal tissues and tumors are irradiated with a similar dose per fraction of 1.8-2 Gy, whereas with IMRT dose gradients are introduced in such a manner that normal tissues receive a much lower dose per fraction.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1 Patients	Experimental	Radiotherapy Patients	Drug: Radiotherapy
Group 2	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Radiotherapy	Drug	Radiotherapy	Group 1 Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
acute toxicity	acute toxicity	during treatment and during the first 3 months following the completion of radiotherapy

Secondary Outcomes

Measure	Description	Time Frame
composite endpoint	composite including loco-regional control, disease-free survival, survival and late toxicity	from ratiotherapy until 2 years after completion of radiotherapy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients older than 18 years
Patients with squamous cell carcinoma of the oropharynx, hypopharynx and larynx
Stage T2-N0-M0, T2-N1-M0 or T3-N0-M0
World Health Organization (WHO) Performance Status of 0 or 1 or Karnofsky performance status ≥ 70.
Provision of written informed consent

Exclusion Criteria:

Second primary tumor at the time of diagnosis
Previous history of malignant tumor in the last five years except basal cell carcinoma and carcinoma in situ of the cervix
Previous treatment with surgery, radiotherapy or chemotherapy for head and neck malignancy
Any evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, cardiac, hepatic or renal disease), or psychological disorder
Pregnant or lactating women

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vincent Gregoire, MD, PhD	Cliniques universitaires Saint Luc Brussels Belgium	Study Chair
Philippe Maingon, MD, PhD	Centre George-François Leclerc Dijon, France	Study Chair
Sandra Nuyts, MD	University hospital Gasthuisberg, Katholiek universiteit van Leuven	Principal Investigator
Gilles Calais, MD, PhD	CHU de Tours, Bretonneau	Principal Investigator
Antoine Serre, MD	centre Val d'Aurelle, Montpellier	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cliniques Universitaires Saint Luc		Brussels		1200	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D002294	Carcinoma, Squamous Cell

Ancestor Terms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided