Clinical Trial: IMRT Plus Cisplatin Versus Conventional Radiotherapy Plus Cisplatin in Stage III-IV HNSCC

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Phase III Trial of Intensity-modulated Radiotherapy Plus Cisplatin Versus Conventional Radiotherapy Plus Cisplatin in Patients With Stage III-IV Head and Neck Squamous Cell Carcinoma

Brief Summary: This is a multicentric randomized phase III trial comparing intensity-modulated radiotherapy (75 Gy) plus cisplatin versus conventional radiotherapy (70 Gy) plus cisplatin in patients with stage III-IV squamous cell carcinoma of oral cavity, oropharynx or hypopharynx. The main end points are the rate of locoregional control and the rate of xerostomia at 2 years.

Detailed Summary:

This is a multicentric randomized phase III trial comparing intensity-modulated radiotherapy plus concomitant cisplatin versus conventional radiotherapy plus concomitant cisplatin in patients with stage III-IV squamous cell carcinoma of oral cavity, oropharynx or hypopharynx. The main end points are the rate of locoregional control and the rate of xerostomia at 2 years.

The IMRT total dose is 75 Gy (50 Gy to PTV1 and T0 + 25 Gy (10 fractions) to PTV2). The conventional radiotherapy total dose is 70 Gy (50 Gy to PTV1 + 20 Gy (10 fractions) to PTV2). In both arms, the cervical nodes will receive 50 Gy (65 Gy in case of Np) by conventional radiotherapy (IMRT is allowed in the IRMT arm). In the two arms, patients will receive concomitant cisplatin (100 mg/m² D1, D21, D42).


Sponsor: Groupe Oncologie Radiotherapie Tete et Cou

Current Primary Outcome: Loco regional control [ Time Frame: 2 years ]

Original Primary Outcome: Loco regional control

Current Secondary Outcome:

  • Survival [ Time Frame: 2 years ]
  • Xerostomia at 2 years (evaluated by parotid gland scintigraphy) [ Time Frame: 2 years ]
  • Quality of life (EORTC-QLQ-H&N35) [ Time Frame: 2 years ]


Original Secondary Outcome:

  • Survival
  • Xerostomia at 2 years (evaluated by parotid gland scintigraphy)
  • Quality of life (EORTC-QLQ-H&N35)


Information By: Groupe Oncologie Radiotherapie Tete et Cou

Dates:
Date Received: September 9, 2005
Date Started: September 2005
Date Completion: February 2018
Last Updated: March 23, 2015
Last Verified: March 2015