Clinical trial · Interventional
Reduced Radiotherapy With Pac/Cis vs Standard Radiotherapy With 5-FU/Cis in Locally Advanced Head and Neck Cancer
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 Radiotherapy (63,6 Gy) With Paclitaxel/Cisplatin to Standard Radiotherapy (70,2 Gy) With 5-Fluorouracil/Cisplatin
NCT01126216CI-TRIAL-00051595Paccis-RCTterminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): After an Interims analysis the Data Safety Monitoring board recommended this because no significant difference between the two arms was seen and was not expected with an reasonable recruitment of patients. No interruptions of the trial were made.
Summary
Brief summary (as posted)
Reduced RT with Pac/Cis vs. standard RCT with 5-FU/Cis
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU/Cisplatin | Drug | — | UNRESOLVED |
| Paclitaxel/Cisplatin | Drug | — | UNRESOLVED |
| Reduced RT | Radiation | — | UNRESOLVED |
| Standard RT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Reduced RT + Pacitaxel/Cisplatin
- description
- 63,6 Gy accelerated hyperfractionated radiotherapy with Paclitaxel (20mg/m\^2/d) on days 2, 5, 8, 11 and 25, 30, 33, 36) and Cisplatin (20mg/m\^2/d) on days 1-4 and 29-32, followed by a salvage operation or neck dissection if there is persisting tumor
- interventionNames
- Drug: Paclitaxel/Cisplatin
- Radiation: Reduced RT
- type
- ACTIVE_COMPARATOR
- label
- Standard RT + 5-Fluorouracil/Cisplatin
- description
- 70,6 Gy accelerated hyperfractionated radiotherapy with 5-Fluorouracil(600mg/m\^2/d) on days 1-5 and 29-33) and Cisplatin (20mg/m\^2/d) on days 1-5 and 29-33, followed by a salvage operation or neck dissection if there is persisting tumor
- interventionNames
- Drug: 5-FU/Cisplatin
- Radiation: Standard RT
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * Age ≥ 18 * Written informed consent for the participation in the clinical trial Exclusion Criteria: * Inadequate hepatic function: Bilirubin \> 2,0 mg/dl, SGOT, SGPT, AP, Gamma-GT \> 3 x ULN * Inadequate bone marrow function: leukocytes \< 3,5 x 10\^9/l, platelets \< 100 x 10\^9/l or neutrophils \< 1,5 x 10\^9/l * Serum creatinine \> 1,5 mg/dl, creatinine clearance \< 60ml/min * Uncontrolled severe somatic or psychological disease: e.g. unstable angina pectoris; myocardial infarction during the last 6 months; significant cardial rhythm disorders; apoplexy; high grade stenosis of the carotis; neurological or psychiatric disorders including convulsive disorders; dementia; psychosis; active uncontrolled infection or sepsis; liver cirrhosis; Child stage B,C; severe liver function disorders; marginal changes in the blood count; severe kidney damage; HIV-infection * Acute infections * Fertile women without adequate contraception during and up to 6 months after therapy (the method of contraception has to be high effective as described in the Note for guidance on non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals (CPMP/ICH/286/95 mod) and it has to be discussed with the investigator) * Pregnant or breast feeding women * Men, who are not willing to use adequate contraception during and up to 6 months after therapy, that is discussed with the investigator * ECOG-Status \> 1 * Reduced hearing function (especially higher frequencies) * Exsiccosis * Neuropathy, caused by cisplatin * Concurrent malignancies, with exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma or the cervix * Prior radiotherapy of the neck or chemotherapy * Distant metastasis * Recurrent carcinoma in the head and neck region * Prior neck-dissection or surgical intervention exceeding an exploratory excision * Known intolerance to 5-Fluorouracil * Known deficit of Dihydropyrimidine dehydrogenase (DPD) * Simultaneous therapy with Brivudin or other inhibitors of DPD * Known intolerance to Cisplatin or other substances that contain platin * Known intolerance to Paclitaxel or one of the included substances, especially to Poly(oxyethylene)Rhizinusöl/Macrogolglycerol ricinoleate
References
Publications (1)
- DERIVEDFietkau R, Hecht M, Hofner B, Lubgan D, Iro H, Gefeller O, Rodel C, Hautmann MG, Kolbl O, Salay A, Rube C, Melchior P, Breinl P, Krings W, Gripp S, Wollenberg B, Keerl R, Schreck U, Siekmeyer B, Grabenbauer GG, Balermpas P; PacCis-Study Group. Randomized phase-III-trial of concurrent chemoradiation for locally advanced head and neck cancer comparing dose reduced radiotherapy with paclitaxel/cisplatin to standard radiotherapy with fluorouracil/cisplatin: The PacCis-trial. Radiother Oncol. 2020 Mar;144:209-217. doi: 10.1016/j.radonc.2020.01.016. Epub 2020 Feb 7. PMID 32044419