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

All India Institute Of Medical Science (AIIMS)

Status and phase: Unknown; Phase 3

Conditions: CARCINOMA LARYNX; HEAD AND NECK CANCER; CARCINOMA OROPHARYNX; CARCINOMA PYRIFORM SINUS

Treatments: Radiation: EPID Verification; Radiation: CBCT verification

Study type: Interventional

Funder types: Other

Identifiers

NCT01124409

3DIGHNC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

3DCRT with EPID

Active Comparator group

Description:

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.

Treatment:

Radiation: EPID Verification

IGRT with CBCT

Active Comparator group

Description:

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.

Treatment:

Radiation: CBCT verification