Reduced Radiotherapy With Pac/Cis vs Standard Radiotherapy With 5-FU/Cis in Locally Advanced Head and Neck Cancer (Paccis-RCT)

This study is ongoing, but not recruiting participants.
Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School Identifier:
First received: May 17, 2010
Last updated: October 22, 2015
Last verified: October 2015
Reduced RT with Pac/Cis vs. standard RCT with 5-FU/Cis

Condition Intervention Phase
Head and Neck Cancer
Drug: Paclitaxel/Cisplatin
Radiation: Reduced RT
Drug: 5-FU/Cisplatin
Radiation: Standard RT
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:
  • Disease free survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Distant metastasis free survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Local control [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Acute and Late Toxicity [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Life Quality [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • HPV/p16-Status [ Time Frame: End of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 542
Study Start Date: May 2010
Estimated Study Completion Date: June 2018
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Reduced RT + Pacitaxel/Cisplatin
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
Drug: Paclitaxel/Cisplatin
Experimental: 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,
Radiation: Reduced RT
Experimental: 63,6 Gy accelerated hyperfractionated radiotherapy
Active Comparator: Standard RT + 5-Fluorouracil/Cisplatin
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
Drug: 5-FU/Cisplatin
Active Comparator: 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
Radiation: Standard RT
Active Comparator: 70,6 Gy accelerated hyperfractionated radiotherapy

Detailed Description:

Standard treatment for patients with advanced, unresectable head and neck cancer is a platin-based simultaneous radiochemotherapy (RCT) (Pignon JP et al., Lancet 2000;355:949-955). However, irradiation dose is still debatable regarding local tumor control and late toxicity. Moreover, it is still unclear which combination of different drugs might be more effective.

In recent years, new drugs have been introduced in the field of head and neck cancer. The Taxanes, namely Docetaxel and Paclitaxel, have been investigated in several phase I/II-studies, and showed promising results concerning locoregional control rates and survival data. The RTOG 97-03 trial (Garden et al., J Clin Oncol 2004; 22:2856-64) compared a RCT either with Cisplatin/5-FU or Cisplatin/Paclitaxel. In this phase II-study an improvement of local tumor control and disease free survival of 15-20% in favour of the Cisplatin/Paclitaxel treatment arm was seen.

Therefore, our phase III-trial compares a standard RCT (70.6 Gy) with Cisplatin/5-FU to a RCT with Cisplatin/Paclitaxel and reduced irradiation dose (63.6 Gy). Primary endpoint is to proof superiority of the experimental Cisplatin/Paclitaxel treatment arm concerning disease-free-survival. Secondary endpoints are locoregional tumor control, overall survival and quality of life.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01126216

Klinikum Coburg, Strahlentherapie, DiaCura
Coburg, Germany, 96450
Universitätsklinikum Düsseldorf, Klinik und Poliklinik für Strahlentherapie und Radiologische Onkologie
Düsseldorf, Germany, 40225
Universitätsklinikum Erlangen, Strahlenklinik
Erlangen, Germany, 91054
Universitätsklinikum Frankfurt, Klinik für Strahlentherapie und Radioonkologie
Frankfurt/M., Germany, 60590
Klinikum am Eichert, Praxis für Strahlentherapie und Klinik für Radioonkologie
Göppingen, Germany, 73035
Universitätsklinikum des Saarlandes, Klinik für Strahlentherapie und Radioonkologie,
Homburg/Saar, Germany, 66421
Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Klinik und Poliklinik für Hals-Nasen- und Ohrenkranke
Lübeck, Germany, 23538
Kliniken Maria Hilf GmbH Mönchengladbach, Klinik für Strahlentherapie
Mönchengladbach, Germany, 41063
Klinikum München Pasing und Perlach, Klinik für HNO
München, Germany, 81241
Brüderkrankenhaus st. Josef Paderborn, Klinik für Strahlentherapie
Paderborn, Germany, 33098
Universitätsklinikum Regensburg, Klinik und Poliklinik für Strahlentherapie
Regensburg, Germany, 93053
Klinikum St. Elisabeth Straubing, Klinik für Hals-Nasen-Ohren-Heilkunde
Straubing, Germany, 94315
MVZ am Klinikum Mutterhaus der Borrmäerinnen, Strahlentherapie
Trier, Germany, 54290
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Deutsche Krebshilfe e.V., Bonn (Germany)
Study Director: Rainer Fietkau, MD Strahlenklinik, Universitätsklinikum Erlangen
  More Information

No publications provided

Responsible Party: University of Erlangen-Nürnberg Medical School Identifier: NCT01126216     History of Changes
Other Study ID Numbers: Paccis-RCT_2005, 2005-003484-23, 107028
Study First Received: May 17, 2010
Last Updated: October 22, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Erlangen-Nürnberg Medical School:
head and neck cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators processed this record on December 01, 2015