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Evaluation of 3DCRT Versus IGRT and Analysis of Early Response in Head and Neck Cancer.

Randomised Clinical Phase III Study of Radiotherapy Dose, Volume Evaluation for 3DCRT Versus IGRT and Analysis of Early Response in Head and Neck Squamous Cell Carcinoma

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01124409
Enrollment
41
Registered
2010-05-17
Start date
2009-12-31
Completion date
2011-08-31
Last updated
2011-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CARCINOMA LARYNX, CARCINOMA OROPHARYNX, CARCINOMA PYRIFORM SINUS, HEAD AND NECK CANCER

Keywords

IGRT, 3DCRT, EPID, CBCT, HNSCC

Brief summary

This study aims to study the impact image guided radiotherapy with Cone beam CT will have on the outcomes(toxicities and response) of head and neck cancer when compared to 3D conformal radiotherapy without CBCT based setup error verification.Also,the various dosimetric variations in Adaptive RT will be studied.

Detailed description

Aims and Objectives 1. To assess the patient's radiation dose planning for GTV, CTV and PTV for primary and nodal regions and derive comparison between IGRT and 3D-CRT. 2. To assess the dosimetric variation in different phases of adaptive RT due to changes in tumor shape and volume during the course of entire treatment in IGRT arm in head and neck cancer patients. 3. To evaluate the optimal setup correction methodology using planar (EPID) and volumetric images (CBCT) in HNSCC between 3D-CRT and IGRT treatment delivery respectively. 4. To compare the early tumour response and acute and chronic radiation morbidities between IGRT and 3D-CRT.

Interventions

RADIATIONEPID Verification

Set up error verification and correction by EPID

RADIATIONCBCT verification

Setup error verification and correction by CBCT

Sponsors

All India Institute of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Histopathologically proven cases of Carcinoma Oropharynx,Larynx,Hypopharynx, stages T1-4 N0-2a M0 * Informed Consent * KPS score \> 70

Exclusion criteria

* Uncontrolled medical comorbidity * Not ready for follow up * Previous cancer directed therapy

Design outcomes

Primary

MeasureTime frameDescription
compare the early tumour response between 3DCRT and IGRT in head and neck cancer.Assessment at post RT week, 1 month after completion of RT and 6 month after completion of RT. Final assessment of last recruited patient is anticipated to be by AUGUST 2011The advent of CBCT has increased the verification of Radiation treatment delivery but whether it leads to significant change in tumour response or toxicities when compared to 3D Conformal Radiotherapy without CBCT verification is not known.This study will give insights into this question.

Secondary

MeasureTime frameDescription
To assess and compare early and late toxicities between 3DCRT and IGRT in head and neck cancerassessment of acute and chronic toxicities of the last recruited patient anticipated to be by March 2011Assessment will be done by RTOG scoring criteria
To find out the different doses received by target and organs at risk during the various phases of adaptive RT.last measurement by AUG 2011

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026