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

Oral Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00158678
• Other study ID #: GORTEC 2004-01
• Status: Completed
• Phase: Phase 3
• Start date: September 27, 2005
• Est. completion date: March 22, 2020

Study information

• Verified date: April 2020
• Source: Groupe Oncologie Radiotherapie Tete et Cou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: March 22, 2020
• Est. primary completion date: March 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• squamous cell carcinoma of oral cavity, oropharynx or hypopharynx

• Stage III - IV (T1-T4, N0-N2)(UICC 2002)

• Not resected

• Indication of radiotherapy to bilateral cervical nodes at dose>= 50 Gy

• Delineation of target volumes done before randomization

• Scintigraphy of parotid gland done before radiotherapy start

• Quality of life questionnaires (EORTC-C30 and EORTC-H&N35) filled in by the patient

• Informed consent signed

Exclusion Criteria:

• N3 (UICC 2002)

• Distant metastasis

• Contra-indication to concomitant cisplatin

• History of cancer within the last 5 years

• History of head and neck radiotherapy

• Administration of drugs for treatment or prophylaxis of xerostomia (pilocarpine, ethyol)

Related Conditions & MeSH terms

• Hypopharynx Cancer
• Mouth Neoplasms
• Oral Cancer
• Oropharyngeal Neoplasms
• Oropharynx Cancer

Intervention

Procedure:
• IMRT 75 Gy
50 Gy in PTV1 and 25 Gy in 10 fractions in PTV2
• Conventional radiotherapy 70 Gy
50 Gy in PTV1 and 20 Gy in PTV2

Drug:
• concomitant cisplatin
100 mg/m2 D1, D22, D43

Locations

Country	Name	City	State
France	Centre Alexis Vautrin	Vandoeuvre les Nancy
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Oncologie Radiotherapie Tete et Cou

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Loco regional control		2 years
Secondary	Survival		2 years
Secondary	Xerostomia at 2 years (evaluated by parotid gland scintigraphy)		2 years
Secondary	Quality of life (EORTC-QLQ-H&N35)		2 years

External Links

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