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

Conditions

Hypopharynx Cancer, Oral Cancer, Oropharynx Cancer

Keywords

oral cancer, oropharynx cancer, hypopharynx cancer, IMRT

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).

Yungan Tao, Anne Aupérin, Pierre Blanchard, M. Alfonsi, Xu-Shan Sun et al. (21 authors)

Radiotherapy and Oncology2020-05-1529 citations

10.1016/j.radonc.2020.05.021

Concurrent cisplatin and dose escalation with intensity-modulated radiotherapy (IMRT) versus conventional chemo-radiotherapy for locally advanced (LA) head and neck squamous cell carcinomas (HNSCC): GORTEC 2004-01 randomized phase III trial

Yungan Tao, A. Aupérin, Pierre Blanchard, M. Alfonsi, X.S. Sun et al. (16 authors)

Annals of Oncology2018-10-01

10.1093/annonc/mdy287.010

Dose escalation of radiotherapy (RT) for locally advanced head and neck carcinomas treated with concomitant chemotherapy (CT) and RT: Results of the GORTEC 2004-01 randomized trial.

Jean Bourhis, Anne Aupérin, M. Alfonsi, Xu Sun, Michel Rives et al. (11 authors)

Journal of Clinical Oncology2017-05-209 citations

10.1200/jco.2017.35.15_suppl.6015

Interventions

PROCEDUREIMRT 75 Gy

50 Gy in PTV1 and 25 Gy in 10 fractions in PTV2

PROCEDUREConventional radiotherapy 70 Gy

50 Gy in PTV1 and 20 Gy in PTV2

DRUGconcomitant cisplatin

100 mg/m2 D1, D22, D43

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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)

Design outcomes

Primary

Measure	Time frame
Loco regional control	2 years

Secondary

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

Countries

France

Outcome results

None listed