DAHANCA 28A: Phase I/II Study on Accelerated, Hyperfractionated Radiotherapy With Concomitant Cisplatin and Nimorazole

Danish Head and Neck Cancer Group

Status and phase: Completed; Phase 2; Phase 1

Conditions: HNSCC,Larynx, Pharynx and Oral Cavity

Treatments: Radiation: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01733823

DAHANCA 28A

Details and patient eligibility

About

P16 negative cancers continue to have a dismal prognosis despite advances in the treatment of head and neck cancer. Acceleration, dose-escalation, hyperfractionation, chemotherapy and nimorazole has been shown to improve local control. The purpose of the study i to investigate the level of co-morbidity and performance status (PS) that allows the combination of all of the above means of treatment intensification

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Squamous Cell Carcinoma head and neck cancer of the pharynx, larynx and oral cavity
• P16 negative
• T1-4
• N1-3
• M0
• Organ function and performance status allowing radical chemo-radiotherapy

Exclusion criteria

• None

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 4 patient groups

Group A

Experimental group

Description:

Performance scale 0-1, Charlson co-morbidity score=0 Treatment: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole

Treatment:

Radiation: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole

Group B

Experimental group

Description:

PS 0-1 Charlson=1 Treatment: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole

Treatment:

Radiation: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole

Group C

Experimental group

Description:

PS 0-1 Charlson \>=2 Will start inclusion after Group A and B Treatment: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole

Treatment:

Radiation: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole

Group D

Experimental group

Description:

PS 2, Charlson: Any Will start inclusion after Group C Treatment: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole

Treatment:

Radiation: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole