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Phase I/II Study on Accelerated, Hyperfractionated Radiotherapy With Concomitant Cisplatin and Nimorazole for Patients With Stage III-IV p16 Negative Squamous Cell Cancer (SCC) of the Larynx, Pharynx and Oral Cavity


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
P16 Negative SCC Head and Neck Cancer of the Larynx, Pharynx and Oral Cavity

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Trial Information

Phase I/II Study on Accelerated, Hyperfractionated Radiotherapy With Concomitant Cisplatin and Nimorazole for Patients With Stage III-IV p16 Negative Squamous Cell Cancer (SCC) of the Larynx, Pharynx and Oral Cavity


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Compliance

Outcome Description:

Proportion of patients that receive radiotherapy in accordance to prescribed dose and treatment time

Outcome Time Frame:

End of radiotherapy (approximately 5.5 weeks after start of radiotherapy)

Safety Issue:

Yes

Principal Investigator

Jens Overgaard, DrMSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

Danish Head and Neck Cancer Group

Authority:

Denmark: Ethics Committee

Study ID:

DAHANCA 28A

NCT ID:

NCT01733823

Start Date:

January 2013

Completion Date:

March 2018

Related Keywords:

  • P16 Negative SCC Head and Neck Cancer of the Larynx, Pharynx and Oral Cavity
  • Laryngeal Neoplasms
  • Neoplasms, Squamous Cell
  • Head and Neck Neoplasms

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