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Trial record 1 of 1 for:    PacCis-RCT
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Reduced Radiotherapy With Pac/Cis vs Standard Radiotherapy With 5-FU/Cis in Locally Advanced Head and Neck Cancer (Paccis-RCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01126216
Recruitment Status : Terminated (

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.

)
First Posted : May 19, 2010
Last Update Posted : May 4, 2021
Sponsor:
Collaborator:
Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

Study Description
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Brief Summary:
Reduced RT with Pac/Cis vs. standard RCT with 5-FU/Cis

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

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 221 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : June 2010
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Disease free survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 3 years ]
  2. Distant metastasis free survival [ Time Frame: 3 years ]
  3. Local control [ Time Frame: 3 years ]
  4. Acute and Late Toxicity [ Time Frame: 4 years ]
  5. Life Quality [ Time Frame: 4 years ]
  6. HPV/p16-Status [ Time Frame: End of study ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01126216


Locations
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Germany
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)
Investigators
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Study Director: Rainer Fietkau, MD Strahlenklinik, Universitätsklinikum Erlangen
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT01126216    
Other Study ID Numbers: Paccis-RCT_2005
2005-003484-23 ( EudraCT Number )
107028 ( Other Grant/Funding Number: Deutsche Krebshilfe e. V. )
First Posted: May 19, 2010    Key Record Dates
Last Update Posted: May 4, 2021
Last Verified: August 2017
Keywords provided by University of Erlangen-Nürnberg Medical School:
Radiochemotherapy
head and neck cancer
Paclitaxel
Cisplatin
5-FU
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Paclitaxel
Cisplatin
Antineoplastic Agents, Phytogenic
 Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action