PacCis-RCT

Randomised phase-III-trial of simultaneous radiochemotherapy (RCT) of locally advanced head and neck cancer in the stages III and IV A-B: Comparing dose reduced RCT (63.6 Gy) with Paclitaxel/Cisplatin to standard RCT (70.2 Gy) with 5-Fluorouracil/Cisplatin - PacCis-RCT

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-003484-23-DE

Enrollment

542

Registered

2009-12-16

Start date

2010-04-14

Completion date

Unknown

Last updated

2019-04-30

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

Conditions

Head and Neck cancer, Stage III-IV A-B MedDRA version: 18.0 Level: LLT Classification code 10026518 Term: Malignant neoplasm of supraglottis stage III System Organ Class: 100000004864 MedDRA version: 18.0 Level: LLT Classification code 10026185 Term: Malignant neoplasm of oropharynx, unspecified System Organ Class: 100000004864

Interventions

Product Name: Paclitaxel Pharmaceutical Form: Solution for infusion INN or Proposed INN: PACLITAXEL CAS Number: 33069-62-4 Product Name

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically proven, locally advanced stage III-IV A-B (UICC 2002) primary squamous cell carcinoma of the oral cavity, the oropharynx, the hypopharynx, the supraglottic larynx 2. Age = 18 3. Written informed consent for the participation in the clinical trial 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 542 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 542

Exclusion criteria

Exclusion criteria: 1. Unadequate hepatic function: Bilirubin > 2,0 mg/dl, SGOT, SGPT, AP, Gamma-GT > 3 x ULN 2. Unadequate bone marrow function: Leukocytes 1,5 mg/dl, Creatinine-clearance 1 10. Reduced hearing function (especially higher frequencies) 11. Exsiccose 12. Neuropathy, caused by cisplatin 13. Concurrent malignancies, with exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma or the cervix 14. Prior radiotherapy of the neck or chemotherapy 15. Distant metastasis 16. Recurrent carcinoma in the head and neck region 17. Prior neck-dissection or surgical intervention exceeding an exploratory excision 18. Known intolerance to 5-Fluorouracil 19. Known deficite of Dihydropyrimidindehydrogenase (DPD) 20. Simultaneous therapy with Brivudin or other inhibitors of DPD 21. Known intolerance to Cisplatin or other substances that contain platin 22. Known intolerance to Paclitaxel or one of the included substances, especially to Poly(oxyethylen)-35-Rhizinusöl/Macrogolglycerolricinoleat

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): Overall survival Disease free survival Locoregional tumor control rate Acute and long term toxicity Quality of life Analysis of HPV/p16-status ;Timepoint(s) of evaluation of this end point: 4 years after end of RCT	—

Primary

Measure	Time frame
Main Objective: To investigate the superiority of dose reduced radiotherapy (63.6 Gy) with Paclitaxel/Cisplatin versus standard radiotherapy (70.2 Gy) with 5-FU/Cisplatin: NED-Survival ; Secondary Objective: Overall survival Locoregional tumor control rate Quality of life ;Primary end point(s): Disease-free survival;Timepoint(s) of evaluation of this end point: 4 years after end of RCT	—

Countries

Germany

Contacts

Public ContactStudiensekretariat

Universitätsklinikum Erlangen, Strahlenklinik

st-studiensekretariat@uk-erlangen.de++490913185-33968

Outcome results

None listed

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