Definitive Chemo-Radiotherapy for Regionally Advanced Head and Neck Cancer With or Without Up-front Neck Dissection

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

October 31, 2016

Primary Completion Date

November 30, 2023

Study Completion Date

May 31, 2025

Conditions
Head and Neck Neoplasms
Interventions
PROCEDURE

up-front neck dissection

RADIATION

radiotherapy

70 Gy in 35 fractions to the macroscopic disease 50 Gy in 25 fractions (if sequential boost) or 56 Gy in 35 fractions (if simultaneous integrated boost) to the elective volumes 66 Gy in 35 fractions to the post-operative region with lymphatic extracapsular extension (Arm B only)

DRUG

Chemotherapy (Cisplatin)

"100 mg/m2 every three weeks during radiotherapy~In Arm B, chemotherapy can be omitted in case of a cT1-2 primary and a surgical downstaged pN0-1 neck without lymphatic extracapsular extension."

PROCEDURE

Early Salvage Neck Dissection in case of less than cCR (Arm A only)

"Early salvage neck dissection in case of residual lymph node disease will be performed based on the response evaluation by MRI and PET/CT performed 3 and 4 months after the end of (chemo)radiotherapy, respectively (and additional diagnostic modalities if clinically indicated by the physician) and not more than 3 weeks after this post-radiotherapy evaluation.~In Arm A, a successful early salvage neck dissection without the operation of the primary tumor in case of less than clinical complete response (cCR) will be considered a component of the multimodality treatment and not as a failure."

Trial Locations (2)

1205

University Hospital of Geneva, Geneva

3010

Inselspital Bern, Bern

All Listed Sponsors
collaborator

University of Bern

OTHER

lead

Insel Gruppe AG, University Hospital Bern

OTHER