Hyperfractionated accelerated radiotherapy (HART) with concurrent mitomycin C / 5-FU versus cisplatin / 5-FU in locally advanced head and neck squamous cell carcinoma (ARO 04-01/AHMO)

Hyperfractionated accelerated radiotherapy (HART) with concurrent mitomycin C / 5-FU versus cisplatin / 5-FU in locally advanced head and neck squamous cell carcinoma (ARO 04-01/AHMO) - ARO 04-01 / AHMO

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

DRKS

Registry ID

DRKS00040575

Enrollment

360

Registered

2026-06-11

Start date

2004-01-01

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

Squamous cell carcinoma of oropharynx (ICD-10: C09, C10) and hypopharynx (ICD-10: C12, C13)

Interventions

Group 1: Arm A (Mitomycin C / 5-FU): Hyperfractionated accelerated radiotherapy (HART): 72 Gy total / 6 weeks, concomitant boost (30 Gy at 2 Gy/day + 42 Gy as 2 × 1.4 Gy/day) 5-Fluorouracil: 600 mg/m²

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed squamous cell carcinoma of the oropharynx or hypopharynx 2. Primarily inoperable tumours stage III/IV (UICC 6th edition), M0 3. Age 18–70 years 4. WHO performance status 0–2 5. Start of treatment possible within 3 weeks after randomisation 6. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Synchronous/metachronous secondary tumours (except controlled skin carcinoma or CIS cervix uteri) 2. Haematogenous metastases 3. Prior surgery (beyond diagnostic excision/biopsy) 4. Prior radiotherapy to the head and neck region 5. Prior chemotherapy 6. Age > 70 years 7. Lymphoepithelial carcinoma (Schmincke tumour), tumours of the oral cavity/nasopharynx/larynx 8. Severe atherosclerotic comorbidities (e.g., stroke, myocardial infarction, high-grade carotid stenoses) 9. Diastolic hypertension > 100 mm Hg 10. Insulin-dependent diabetes mellitus 11. Severe liver cirrhosis or renal insufficiency 12. Haemoglobin < 10 g/dl within 10 days prior to randomisation 13. HIV infection 14. Inadequate dental status 15. Pregnancy/lactation

Design outcomes

Primary

Measure	Time frame
Overall survival (OS) WHAT: Time from randomization to death from any cause WHEN: Continuous monitoring, analysis after study completion HOW: Vital status from medical records, registry offices, and direct follow-up	—

Secondary

Measure	Time frame
1. Progression-free survival (PFS) 2. Metastasis-free survival (MFS) 3. Locoregional control (LRC) 4. Local control (LC) 5. Regional control (RC) 6. Acute toxicity (CTC v3.0) 7. Late morbidity (RTOG/EORTC) 8. Quality of life	—

Countries

Austria, Germany

Contacts

Public ContactDavid Kaul

Klinik für Radioonkologie und Strahlentherapie, Charité – Universitätsmedizin Berlin

david.kaul@charite.de+49 30 450 527 000

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 29, 2026