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

NCT ID: NCT01733823

Last Updated: 2017-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2016-03-31

Brief Summary

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

Conditions

HNSCC,Larynx, Pharynx and Oral Cavity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

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

Group Type: EXPERIMENTAL

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

Intervention Type: RADIATION

Group B

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

Group Type: EXPERIMENTAL

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

Intervention Type: RADIATION

Group C

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

Group Type: EXPERIMENTAL

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

Intervention Type: RADIATION

Group D

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

Group Type: EXPERIMENTAL

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

Intervention Type: RADIATION

Interventions

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

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Danish Head and Neck Cancer Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jens Overgaard, MD, DMSc

Role: PRINCIPAL_INVESTIGATOR

Danish Head and Neck Cancer Group

Locations

Aarhus

Aarhus, Aarhus C, Denmark

Odense

Odense, Odense C, Denmark

Aalborg

Aalborg, , Denmark

Herlev

Herlev, , Denmark

Countries

Denmark

Other Identifiers

DAHANCA 28A

Identifier Type: -

Identifier Source: org_study_id