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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


Phase 3
18 Years
65 Years
Open (Enrolling)
Both
HEAD AND NECK CANCER, CARCINOMA OROPHARYNX, CARCINOMA PYRIFORM SINUS, CARCINOMA LARYNX

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

compare the early tumour response between 3DCRT and IGRT in head and neck cancer.

Outcome Description:

The 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.

Outcome Time Frame:

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 2011

Safety Issue:

No

Principal Investigator

BIDHU K MOHANTI, MD

Investigator Role:

Study Chair

Investigator Affiliation:

All India Institute of Medical Sciences, New Delhi

Authority:

India: Institutional Review Board

Study ID:

3DIGHNC

NCT ID:

NCT01124409

Start Date:

December 2009

Completion Date:

August 2011

Related Keywords:

  • Head and Neck Cancer
  • CARCINOMA OROPHARYNX
  • CARCINOMA PYRIFORM SINUS
  • CARCINOMA LARYNX
  • IGRT
  • 3DCRT
  • EPID
  • CBCT
  • HNSCC
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Laryngeal Neoplasms

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