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Simultaneous Integrated Boost (SIB)- IMRT

Primary Purpose

Carcinoma, Squamous Cell

Status

Completed

Phase

Phase 2

Locations

Belgium

Study Type

Interventional

Intervention

Radiotherapy

About this trial

This is an interventional treatment trial for Carcinoma, Squamous Cell

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cliniques Universitaires Saint Luc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group 1 Patients

Group 2

Arm Description

Radiotherapy Patients

Outcomes

Primary Outcome Measures

acute toxicity

Secondary Outcome Measures

composite endpoint

composite including loco-regional control, disease-free survival, survival and late toxicity

Full Information

NCT ID

NCT00389727

First Posted

October 18, 2006

Last Updated

July 10, 2019

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Collaborators

Centre Georges Francois Leclerc

1. Study Identification

Unique Protocol Identification Number

NCT00389727

Brief Title

Simultaneous Integrated Boost (SIB)- IMRT

Official Title

A Dose Escalation Study With Intensity Modulated Radiation Therapy (IMRT) in Moderately Advanced (T2N0, T2N1, T3N0) Squamous Cell Carcinomas (SCC) of the Oropharynx, Larynx and Hypopharynx Using a Simultaneous Integrated Boost (SIB) Approach.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

September 24, 2004 (Actual)

Primary Completion Date

May 26, 2008 (Actual)

Study Completion Date

May 26, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Collaborators

Centre Georges Francois Leclerc

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Squamous Cell

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1 Patients

Arm Type

Experimental

Arm Description

Radiotherapy Patients

Arm Title

Group 2

Arm Type

No Intervention

Intervention Type

Drug

Intervention Name(s)

Radiotherapy

Intervention Description

Radiotherapy

Primary Outcome Measure Information:

Title

acute toxicity

Description

acute toxicity

Time Frame

during treatment and during the first 3 months following the completion of radiotherapy

Secondary Outcome Measure Information:

Title

composite endpoint

Description

composite including loco-regional control, disease-free survival, survival and late toxicity

Time Frame

from ratiotherapy until 2 years after completion of radiotherapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials: