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

NCT01126216 | Terminated Phase 3 DMC

• 3 other identifiers: Paccis-RCT_20052005-003484-23107028
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 13

Brief Summary

Reduced RT with Pac/Cis vs. standard RCT with 5-FU/Cis

Conditions

Head and Neck Cancer

Keywords

Radiochemotherapy; head and neck cancer; Paclitaxel; Cisplatin; 5-FU

Outcome Measures

Primary Outcomes (1)

• Disease free survival

  3 years

Secondary Outcomes (6)

• Overall Survival

  3 years

• Distant metastasis free survival

  3 years

• Local control

  3 years

• Acute and Late Toxicity

  4 years

• Life Quality

  4 years

Study Arms (2)

Reduced RT + Pacitaxel/Cisplatin

EXPERIMENTAL

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; Radiation: Reduced RT

Standard RT + 5-Fluorouracil/Cisplatin

ACTIVE COMPARATOR

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; Radiation: Standard RT

Interventions

Paclitaxel/Cisplatin DRUG

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,

Reduced RT + Pacitaxel/Cisplatin

Reduced RT RADIATION

Experimental: 63,6 Gy accelerated hyperfractionated radiotherapy

Reduced RT + Pacitaxel/Cisplatin

5-FU/Cisplatin DRUG

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

Standard RT + 5-Fluorouracil/Cisplatin

Standard RT RADIATION

Active Comparator: 70,6 Gy accelerated hyperfractionated radiotherapy

Standard RT + 5-Fluorouracil/Cisplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead
• Deutsche Krebshilfe e.V., Bonn (Germany): collaborator

Study Sites (13)

Klinikum Coburg, Strahlentherapie, DiaCura

Coburg, 96450, Germany

Location

Universitätsklinikum Düsseldorf, Klinik und Poliklinik für Strahlentherapie und Radiologische Onkologie

Düsseldorf, 40225, Germany

Location

Universitätsklinikum Erlangen, Strahlenklinik

Erlangen, 91054, Germany

Location

Universitätsklinikum Frankfurt, Klinik für Strahlentherapie und Radioonkologie

Frankfurt/M., 60590, Germany

Location

Klinikum am Eichert, Praxis für Strahlentherapie und Klinik für Radioonkologie

Göppingen, 73035, Germany

Location

Universitätsklinikum des Saarlandes, Klinik für Strahlentherapie und Radioonkologie,

Homburg/Saar, 66421, Germany

Location

Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Klinik und Poliklinik für Hals-Nasen- und Ohrenkranke

Lübeck, 23538, Germany

Location

Kliniken Maria Hilf GmbH Mönchengladbach, Klinik für Strahlentherapie

Mönchengladbach, 41063, Germany

Location

Klinikum München Pasing und Perlach, Klinik für HNO

München, 81241, Germany

Location

Brüderkrankenhaus st. Josef Paderborn, Klinik für Strahlentherapie

Paderborn, 33098, Germany

Location

Universitätsklinikum Regensburg, Klinik und Poliklinik für Strahlentherapie

Regensburg, 93053, Germany

Location

Klinikum St. Elisabeth Straubing, Klinik für Hals-Nasen-Ohren-Heilkunde

Straubing, 94315, Germany

Location

MVZ am Klinikum Mutterhaus der Borrmäerinnen, Strahlentherapie

Trier, 54290, Germany

Location

Related Publications (1)

• Fietkau 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 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

TP protocol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Rainer Fietkau, MD

  Strahlenklinik, Universitätsklinikum Erlangen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2010
• First Posted: May 19, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2019
• Last Updated: May 4, 2021

Record last verified: 2017-08

Locations

DE (13)