Clinical trial NCT00158678: IMRT Plus Cisplatin Versus Conventional Radiotherapy Plus Cisplatin in Stage III-IV HNSCC
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Oral Cancer
Oropharynx Cancer
Hypopharynx Cancer
Keywords: oral cancer
oropharynx cancer
hypopharynx cancer
IMRT
Lead sponsor: Groupe Oncologie Radiotherapie Tete et Cou
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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).

Eligibility criteria: 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)

Primary outcomes:
measure: Loco regional control
timeFrame: 2 years
Secondary outcomes:
measure: Survival
timeFrame: 2 years
measure: Xerostomia at 2 years (evaluated by parotid gland scintigraphy)
timeFrame: 2 years
measure: Quality of life (EORTC-QLQ-H&N35)
timeFrame: 2 years
Other outcomes:
Locations:
city: Vandoeuvre les Nancy
country: France
facility: Centre Alexis Vautrin
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Jean Bourhis, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Alexis Vautrin
name: Michel Lapeyre, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tao Y, Auperin A, Blanchard P, Alfonsi M, Sun XS, Rives M, Pointreau Y, Castelli J, Graff P, Wong Hee Kam S, Thariat J, Veresezan O, Heymann S, Renard-Oldrini S, Lafond C, Cornely A, Casiraghi O, Boisselier P, Lapeyre M, Biau J, Bourhis J. Concurrent cisplatin and dose escalation with intensity-modulated radiotherapy (IMRT) versus conventional radiotherapy for locally advanced head and neck squamous cell carcinomas (HNSCC): GORTEC 2004-01 randomized phase III trial. Radiother Oncol. 2020 Sep;150:18-25. doi: 10.1016/j.radonc.2020.05.021. Epub 2020 May 15.