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

NCT ID: NCT01124409

Last Updated: 2011-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-08-31

Brief Summary

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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

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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.

Conditions

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HEAD AND NECK CANCER CARCINOMA OROPHARYNX CARCINOMA PYRIFORM SINUS CARCINOMA LARYNX

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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3DCRT with EPID

this patients randomised to this arm will be planned by 3DCRT and during treatment setup error will be identified and corrected by weekly EPID if error \>3mm.Weekly CBCT will be done for this arm to note the setup error but will not be corrected.

Group Type ACTIVE_COMPARATOR

EPID Verification

Intervention Type RADIATION

Set up error verification and correction by EPID

IGRT with CBCT

The patients randomised to this arm will be planned by 3DCRT and set up error during RT will be verified by CBCT and error corrected if \>3mm.Weekly EPID will be done for setup error documentation but no correction based on EPID in this arm.

Group Type ACTIVE_COMPARATOR

CBCT verification

Intervention Type RADIATION

Setup error verification and correction by CBCT

Interventions

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EPID Verification

Set up error verification and correction by EPID

Intervention Type RADIATION

CBCT verification

Setup error verification and correction by CBCT

Intervention Type RADIATION

Other Intervention Names

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EPID 3DCRT HNSCC CBCT IGRT HNSCC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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All India Institute of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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ALL INDIA INSTITUTE OF MEDICAL SCIENCES

Principal Investigators

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BIDHU K MOHANTI, MD

Role: STUDY_CHAIR

All India Institute of Medical Sciences

Locations

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All India Institute of Medical Sciences

New Delhi, New Delhi, India

Site Status

Countries

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India

Other Identifiers

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3DIGHNC

Identifier Type: -

Identifier Source: org_study_id

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