A randomized multicenter study of radiotherapy with or without nimorazole in the treatment of squamous cell carcinoma of the head and neck

A randomized multicenter study of accelerated fractionated radiotherapy with or without the hypoxic radiosensitizer nimorazole in the treatment of squamous cell carcinoma of the head and neck - IAEA-HypoX

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000528-17-EE

Enrollment

600

Registered

2012-06-14

Start date

2012-06-26

Completion date

Unknown

Last updated

2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Squamous cell carcinoma of the head and neck

Interventions

Trade Name: Nimoral Product Name: Nimoral Pharmaceutical Form: Tablet Trade Name: Nimoral Product Name: Nimoral Pharmaceutical Form: Oral powder

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Tumor classified as stage I-IV located in oropharynx, hypopharynx, larynx (not glottic stage I-II), or oral cavity according to the TNM classification. (2) Histopathological diagnosis of invasive squamous cell carcinoma in the primary tumor. (3) Age > 18 years. (4) Informed consent according to the Helsinki declaration and local regula-tions. (5) The patient must be candidate for external beam radical radiotherapy, and must be expected to accomplish the treatment. (6) Performance status 0-2 according to WHO criteria. (7) The patient should not have symptoms of peripheral neuropathy assessed by clinical examination. (8) Normal function of liver and kidney by routine laboratory examinations. (9) The patient must not be pregnant. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: (1) Distant metastases. (2) The patient should not be in a state or condition that could be expected to influence the outcome of treatment, or complicate the assessment or the treatment follow-up, or (apart from the present disease) reduce the life expectancy. (3) Surgical excision (except biopsy), prior or planned (including elective neck dissection). (4) The existence of synchronous multiple malignancies (not leukoplakia).

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of the study is to determine the possible therapeutic gain of using nimorazole given as a hypoxic radiosensitizer in conjunction with accelerated fractionated radiotherapy of invasive squamous cell carcinoma of the larynx, pharynx and oral cavity;Secondary Objective: Evaluate the tolerance, compliance and toxicity of using nimorazole;Primary end point(s): primary tumor control in T and N position ;Timepoint(s) of evaluation of this end point: 3 years	—

Measure

Time frame

Main Objective: The aim of the study is to determine the possible therapeutic gain of using nimorazole given as a hypoxic radiosensitizer in conjunction with accelerated fractionated radiotherapy of invasive squamous cell carcinoma of the larynx, pharynx and oral cavity;Secondary Objective: Evaluate the tolerance, compliance and toxicity of using nimorazole;Primary end point(s): primary tumor control in T and N position ;Timepoint(s) of evaluation of this end point: 3 years

—

Secondary

Measure	Time frame
Secondary end point(s): - disease specific and overall survival - disease free survival - treatment related acute and late morbidity;Timepoint(s) of evaluation of this end point: 3 years	—

Countries

Estonia, India, Pakistan, Poland, Slovenia

Contacts

Public ContactMaire Kuddu

North Estonia Medical Centre Foundation

maire.kuddu@regionaalhaigla.ee+3726172462

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026