Dose Reduced Radiotherapy (63,3 Gy) With Paclitaxel/Cisplatin Versus Standard Radiotherapy (70,2 Gy) With 5-Fluorouracil/Cisplatin in Locally Advanced Head and Neck Cancer (Stages III and IV A-B) (Paccis-RCT)
This study is currently recruiting participants.
Verified April 2013 by University of Erlangen-Nürnberg Medical School
Sponsor:
University of Erlangen-Nürnberg Medical School
Collaborator:
Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT01126216
First received: May 17, 2010
Last updated: April 2, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Locally Advanced Head and Neck Cancer Stages III and IV A-B |
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 ]
| Estimated Enrollment: | 542 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | June 2018 |
| Estimated Primary Completion Date: | June 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
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
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
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
70,6 Gy accelerated hyperfractionated radiotherapy
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01126216
Contacts
| Contact: Rainer Fietkau, MD | ++49(0)9131-85-33968 | st-studiensekretariat@uk-erlangen.de |
| Contact: Markus Hecht, MD | ++49(0)9131-85-33968 | st-studiensekretariat@uk-erlangen.de |
Locations
| Germany | |
| Klinikum Coburg, Strahlentherapie, DiaCura | Recruiting |
| Coburg, Germany, 96450 | |
| Principal Investigator: Gerhard G. Grabenbauer, MD | |
| Universitätsklinikum Düsseldorf, Klinik und Poliklinik für Strahlentherapie und Radiologische Onkologie | Recruiting |
| Düsseldorf, Germany, 40225 | |
| Principal Investigator: Stephan Gripp, MD | |
| Universitätsklinikum Erlangen, Strahlenklinik | Recruiting |
| Erlangen, Germany, 91054 | |
| Principal Investigator: Rainer Fietkau, MD | |
| Universitätsklinikum Frankfurt, Klinik für Strahlentherapie und Radioonkologie | Recruiting |
| Frankfurt/M., Germany, 60590 | |
| Principal Investigator: Claus M. Rödel, MD | |
| Klinikum am Eichert, Praxis für Strahlentherapie und Klinik für Radioonkologie | Recruiting |
| Göppingen, Germany, 73035 | |
| Principal Investigator: Ulrike Schreck, MD | |
| Universitätsklinikum des Saarlandes, Klinik für Strahlentherapie und Radioonkologie, | Recruiting |
| Homburg/Saar, Germany, 66421 | |
| Principal Investigator: Christian Rübe, MD | |
| Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Klinik und Poliklinik für Hals-Nasen- und Ohrenkranke | Recruiting |
| Lübeck, Germany, 23538 | |
| Principal Investigator: Barbara Wollenberg, MD | |
| Kliniken Maria Hilf GmbH Mönchengladbach, Klinik für Strahlentherapie | Recruiting |
| Mönchengladbach, Germany, 41063 | |
| Principal Investigator: Hans Hoffmanns, MD | |
| Klinikum München Pasing und Perlach, Klinik für HNO | Recruiting |
| München, Germany, 81241 | |
| Principal Investigator: Peter Breinl, MD | |
| Brüderkrankenhaus st. Josef Paderborn, Klinik für Strahlentherapie | Recruiting |
| Paderborn, Germany, 33098 | |
| Principal Investigator: Horst Leber, MD | |
| Universitätsklinikum Regensburg, Klinik und Poliklinik für Strahlentherapie | Recruiting |
| Regensburg, Germany, 93053 | |
| Principal Investigator: Oliver Kölbl, MD | |
| Universitätsklinikum Rostock, Klinik und Poliklinik für Stahlentherapie | Recruiting |
| Rostock, Germany, 18059 | |
| Principal Investigator: Guido Hildebrandt, MD | |
| Klinikum St. Elisabeth Straubing, Klinik für Hals-Nasen-Ohren-Heilkunde | Recruiting |
| Straubing, Germany, 94315 | |
| Principal Investigator: Rainer Keerl, MD | |
| MVZ am Klinikum Mutterhaus der Borrmäerinnen, Strahlentherapie | Recruiting |
| Trier, Germany, 54290 | |
| Principal Investigator: Birgit Siekmeyer, MD | |
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Deutsche Krebshilfe e.V., Bonn (Germany)
Investigators
| Study Director: | Rainer Fietkau, MD | Strahlenklinik, Universitätsklinikum Erlangen |
More Information
No publications provided
| Responsible Party: | University of Erlangen-Nürnberg Medical School |
| ClinicalTrials.gov Identifier: | NCT01126216 History of Changes |
| Other Study ID Numbers: | Paccis-RCT_2005, 2005-003484-23, 107028 |
| Study First Received: | May 17, 2010 |
| Last Updated: | April 2, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by University of Erlangen-Nürnberg Medical School:
|
Radiochemotherapy head and neck cancer Paclitaxel Cisplatin 5-FU |
Additional relevant MeSH terms:
|
Head and Neck Neoplasms Neoplasms by Site Neoplasms Cisplatin Fluorouracil Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents |
Physiological Effects of Drugs Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 23, 2013