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Squamous Cell Carcinoma of the HypopharynxPhase 2DeLOS IINCT00508664

Docetaxel, Cisplatin (TP) + Radiation +/- Cetuximab in Larynx Carcinoma (CA)

A Phase 2 study testing Radiation, Cetuximab and Docetaxel in people with Squamous Cell Carcinoma of the Hypopharynx and Larynx Carcinoma, run by ClinAssess at 27 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The DeLOS II trial is a multicenter randomised phase II trial investigating a TP/5-Fluorouracil (TPF)-chemotherapy with or without cetuximab for Patients with only by laryngectomy operable carcinoma of the larynx/hypopharynx. Patients were divided in responder or non-responder after 4 weeks. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Radiation, Cetuximab and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
27 sitesin 2 countries
Study dates
Jul 2007to Feb 2015
Phase
Phase 2
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed, primary only with laryngectomy respectable squamous-cell carcinoma of the larynx or hypopharynx
  • T3-T4a carcinoma of the glottis
  • T2-T4a carcinoma of the supraglottic, only controllable by laryngectomy and if applicable by root of tongue segmental resection
  • T2-T4a carcinoma of the hypopharynx only controllable by laryngectomy (for example T2, post cricoidal) and hypopharynx segmental resection
  • N-status: cervical metastases (N0-N3) have to be rehabilitate by surgical procedures
  • Blood count: Leukocytes >3500/mm\3, Neutrophils > 1500/ mm\3, Thrombocytes > 8000/ mm\3
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  • Clinical chemistry:
  • adequate renal function, defined by serum creatinine and urea not higher than 25% upper NL, creatinine-clearance > 60 ml/min/1,72 m\2
  • adequate hepatic function with SGOT, SGPT not higher than 50% and bilirubin not higher than upper NL
  • electrolytes at NL
  • anesthetic risk normal or low-grade elevated
  • age 18-75 years
  • written informed consent
  • effective contraception after individual advice for men and women if there is a possibility of reproductive potential (effective contraception are: oral contraception with estrogen and gestagen (no minipill), vaginal ring, contraception patch, estrogen free ovulation suppressors, hormone spiral with progesterone, injection for three month with depot gestagen, hormone releasing implantation (luteal hormone containing rod), abstinence or sterilization (vasectomy) of the male)

Who cannot join

  • primary cancer treatable by operational larynx -conserving procedures
  • distant metastases (M1-Status)
  • total tumor volume exceeding 80 ml or larynx skeleton punctuated with infiltration of surrounding soft tissues respectively the esophageal aditus (exclusive cartilage infiltration represents no exclusion criteria)
  • tumor-specific prior chemo or radiotherapy
  • metachronous or synchronous malignant tumor (exception basalioma) [in case of a controlled tumor of different localization with a non-treated interval over 5 years to the present therapy the patient can be included after consultation with the coordinating investigator]
  • life expectancy < 3 month
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  • Karnofsky performance status < 70%
  • serious cardiopulmonary concomitant disease (cardiac insufficiency grade III and IV according NYHA status, myocardial infarction, angina pectoris, respiratory global insufficiency)
  • Chronic diseases with permanent-therapy (uncontrolled diabetes, active rheumatoid arthritis)
  • recurrent pneumonia, COPD GOLD stage <2, chronic inflammation of intestine or any other concomitant diseases, which disallow study participation in the opinion of the responsible physician
  • Other circumstances (contra-indications), which disallow treatment with Docetaxel, Cisplatin, 5-FU, Cetuximab or radiotherapy
  • Expected absent patient compliance
  • Periodic follow-up not possible (for example address outside germany)
  • Pregnant or breast-feeding woman
  • Absent or constricted legal capacity
  • Participation to another clinical trial with any investigational study within 30 days prior to study screening

Trial locations and contacts

27 sites in 2 countries.

27 sites in 2 countries

Germany24 sites

  • Universitätsklinik Aachen

    Aachen, 52074

  • Charité, Campus Benjamin Franklin

    Berlin, 12200

  • Klinikum Neukölln, Vivantes GmbH

    Berlin, 12351

  • Klinikum Bielefeld-Mitte

    Bielefeld, 33604

  • Universitätsklinik Köln

    Cologne, 50924

  • Malteser Krankenhaus St. Anna gGmbH, HNO-Klinik

    Duisburg, 47259

  • Helios Klinikum Erfurt GmbH Klinik für HNO-Heilkunde, Plastische Operationen

    Erfurt, Thuringia, 99089

  • Klinikum Fulda gAG, Klinik für Hals-Nasen-Ohrenkrankheiten

    Fulda, 36043

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Klinikum Hannover Nordstadt

    Hanover

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • Universitätsklinikum Jena

    Jena, 07743

  • St. Vincentius Kliniken

    Karlsruhe

  • Klinikum Kassel GmbH

    Kassel, 34125

  • Katholisches Klinikum Koblenz Marienhof

    Koblenz, 56073

  • Universitätsklinikum Leipzig

    Leipzig, 04103

  • Universtitätsklinikum Schleswig-Holstein

    Lübeck, 23538

  • Klinikum Großhadern

    München, 81377

  • Medizinische Fakultät der Westfälischen Wilhelms-Universität Münster

    Münster, 48149

  • Südharz-Krankenhaus Nordhausen gGmbH

    Nordhausen

  • Klinikum Ernst von Bergmann gGmbH

    Potsdam, 14467

  • Universtitätsklinikum Regensburg

    Regensburg

  • Klinikum Stuttgart Katharinenhospital, Klinik für HNO-Krankheiten

    Stuttgart, 70174

  • Bayerischen Julius Maximillians-Universtät Würzburg

    Würzburg, 97080

Other trials in Germany

Austria3 sites

  • Universitätsklinik für HNO

    Graz, 8036

  • Landeskrankenhaus Klagenfurt

    Klagenfurt, A-9020

  • Allgemeines Krankenhaus der Stadt Wien

    Vienna, 1090

Other trials in Austria

About this study

Official title: Randomised Phase II Screening Study to be Used in an TP/TPF-chemotherapy (Short Induction) Before TP/TPF-induction, Radiotherapy With or Without Cetuximab in the Primary Therapy of the Only by Laryngectomy Operable Carcinoma of the Larynx/Hypopharynx

The DeLOS II trial is a multicenter randomised phase II trial investigating a TP/5-Fluorouracil (TPF)-chemotherapy with or without cetuximab for Patients with only by laryngectomy operable carcinoma of the larynx/hypopharynx. Patients were divided in responder or non-responder after 4 weeks. Since August 2009 Responder receive TP with or without Cetuximab + radiation. (Until february 2009 Responder received TPF with or without Cetuximab + radiation.) Planned accrual is 85 patients per treatment arm. The primary study endpoint is a confirmatory proof of an adequate survival rate with a functionally larynx-conserving 2 years after randomisation.

Being tested
Radiation, Cetuximab, Docetaxel, Cisplatin (TP), 5-Fluorouracil (TPF) (only until Feb 2009)
Keywords
by laryngectomy operable carcinoma of the larynx and the hypopharynx
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Laryngeal Neoplasms

What participants receive

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

  • RadiationRadiation

    Radiation start in week 11

  • CetuximabDrug

    Day 1 400mg/m2 i.v. than weekly 250 mg/m2 i.v. for 16 weeks

  • DocetaxelDrug

    Also called Taxotere

    75 mg/m2 i.v. day 1 3 times

  • Cisplatin (TP)Drug

    75 mg/m2 i.v. day 1 3 times

  • 5-Fluorouracil (TPF) (only until Feb 2009)Drug

    Only patients recruited until Feb 2009: 750 mg/m2 i.v. day 1-5, 3 times

Study groups in NCT00508664
Study groupRoleWhat they receive
AExperimentalTP + Radiation (TPF until Feb 2009)
Receives: Radiation: Radiation; Drug: Docetaxel; Drug: Cisplatin (TP); Drug: 5-Fluorouracil (TPF) (only until Feb 2009)
BExperimentalTP + Cetuximab + Radiation (TPF until Feb 2009)
Receives: Radiation: Radiation; Drug: Cetuximab; Drug: Docetaxel; Drug: Cisplatin (TP); Drug: 5-Fluorouracil (TPF) (only until Feb 2009)

What is being measured

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

  1. Confirmatory proof of an adequate survival rate with a functionally larynx-conserving 2 years after randomisation

    Measured: LFS-rate 2 years after randomisation

Secondary outcomes (2)

  1. Descriptive analysis of the study arms concerning the secondary end criteria of the study

    Measured: LSF 2 years after randomisation

  2. Explorative comparison of the study arms concerning the primary and secondary end criteria of the study

    Measured: LSF 2 years after randomisation

Timeline

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

  1. First posted30 Jul 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionFeb 2015
  4. Study completionFeb 2015

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00508664
Sponsor's protocol ID
TP(F)+Radiation+/-Cetuximab
Acronym
DeLOS II
Status last verified
Jun 2015
First submitted
27 Jul 2007
Last updated
2 Jun 2015
Results posted
No
Data monitoring committee
No

Publications

  • Dietz A, Wichmann G, Kuhnt T, Pfreundner L, Hagen R, Scheich M, Kolbl O, Hautmann MG, Strutz J, Schreiber F, Bockmuhl U, Schilling V, Feyer P, de Wit M, Maschmeyer G, Jungehulsing M, Schroeder U, Wollenberg B, Sittel C, Munter M, Lenarz T, Klussmann JP, Guntinas-Lichius O, Rudack C, Eich HT, Foerg T, Preyer S, Westhofen M, Welkoborsky HJ, Esser D, Thurnher D, Remmert S, Sudhoff H, Gorner M, Bunzel J, Budach V, Held S, Knodler M, Lordick F, Wiegand S, Vogel K, Boehm A, Flentje M, Keilholz U. Induction chemotherapy (IC) followed by radiotherapy (RT) versus cetuximab plus IC and RT in advanced laryngeal/hypopharyngeal cancer resectable only by total laryngectomy-final results of the larynx organ preservation trial DeLOS-II. Ann Oncol. 2018 Oct 1;29(10):2105-2114. doi: 10.1093/annonc/mdy332.

    PubMed 30412221

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Radiation, Cetuximab and Docetaxel in people with Squamous Cell Carcinoma of the Hypopharynx and Larynx Carcinoma, run by ClinAssess at 27 sites in 2 countries.

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 14 inclusion and 16 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: finished, as of the sponsor's last update on 2 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Germany, Austria. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Confirmatory proof of an adequate survival rate with a functionally larynx-conserving 2 years after randomisation (time frame: LFS-rate 2 years after randomisation). 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 NCT00508664, 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 2 Jun 2015.

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