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Head and Neck CancerPhase 3Paccis-RCTNCT01126216

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

A Phase 3 study testing Paclitaxel/Cisplatin, Reduced RT and 5-FU/Cisplatin in people with Head and Neck Cancer, run by University of Erlangen-Nürnberg Medical School at 13 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Reduced RT with Pac/Cis vs. standard RCT with 5-FU/Cis Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
Paclitaxel/Cisplatin, Reduced RT and 5-FU/Cisplatin
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
221 participants
Where
13 sitesGermany
Study dates
Jun 2010to Jun 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 22Show fewer
  • 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

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Germany13 sites

  • Klinikum Coburg, Strahlentherapie, DiaCura

    Coburg, 96450

  • Universitätsklinikum Düsseldorf, Klinik und Poliklinik für Strahlentherapie und Radiologische Onkologie

    Düsseldorf, 40225

  • Universitätsklinikum Erlangen, Strahlenklinik

    Erlangen, 91054

  • Universitätsklinikum Frankfurt, Klinik für Strahlentherapie und Radioonkologie

    Frankfurt/M., 60590

  • Klinikum am Eichert, Praxis für Strahlentherapie und Klinik für Radioonkologie

    Göppingen, 73035

  • Universitätsklinikum des Saarlandes, Klinik für Strahlentherapie und Radioonkologie,

    Homburg/Saar, 66421

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

    Lübeck, 23538

  • Kliniken Maria Hilf GmbH Mönchengladbach, Klinik für Strahlentherapie

    Mönchengladbach, 41063

  • Klinikum München Pasing und Perlach, Klinik für HNO

    München, 81241

  • Brüderkrankenhaus st. Josef Paderborn, Klinik für Strahlentherapie

    Paderborn, 33098

  • Universitätsklinikum Regensburg, Klinik und Poliklinik für Strahlentherapie

    Regensburg, 93053

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

    Straubing, 94315

  • MVZ am Klinikum Mutterhaus der Borrmäerinnen, Strahlentherapie

    Trier, 54290

Other trials in Germany

About this study

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

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

Read the 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.

Being tested
Paclitaxel/Cisplatin, Reduced RT, 5-FU/Cisplatin, Standard RT
Keywords
Radiochemotherapy, head and neck cancer, Paclitaxel, Cisplatin, 5-FU
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Paclitaxel/CisplatinDrug

    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 RTRadiation

    Experimental: 63,6 Gy accelerated hyperfractionated radiotherapy

  • 5-FU/CisplatinDrug

    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 RTRadiation

    Active Comparator: 70,6 Gy accelerated hyperfractionated radiotherapy

Study groups in NCT01126216
Study groupRoleWhat they receive
Reduced RT + Pacitaxel/CisplatinExperimental63,6 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
Receives: Drug: Paclitaxel/Cisplatin; Radiation: Reduced RT
Standard RT + 5-Fluorouracil/CisplatinActive comparator70,6 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
Receives: Drug: 5-FU/Cisplatin; Radiation: Standard RT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease free survival

    Measured: 3 years

Secondary outcomes (6)

  1. Overall Survival

    Measured: 3 years

  2. Distant metastasis free survival

    Measured: 3 years

  3. Local control

    Measured: 3 years

  4. Acute and Late Toxicity

    Measured: 4 years

  5. Life Quality

    Measured: 4 years

  6. HPV/p16-Status

    Measured: End of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionJun 2015
  4. Study completionJun 2019

Why it stopped: 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
221 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01126216
Sponsor's protocol ID
Paccis-RCT_2005
Other IDs
2005-003484-23, 107028, 2005
Acronym
Paccis-RCT
Status last verified
Aug 2017
First submitted
17 May 2010
Last updated
4 May 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 32044419

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Paclitaxel/Cisplatin, Reduced RT and 5-FU/Cisplatin in people with Head and Neck Cancer, run by University of Erlangen-Nürnberg Medical School at 13 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: 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.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01126216, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2021.

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