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Oropharynx CancerPhase 1/2NCT01108042

TPF-Induction Chemotherapy of Oropharyngeal and Cavity of the Mouth Cancer

A Phase 1/2 study testing Taxotere, Cisplatin, 5-Fluorouracil (5-FU) in people with Oropharynx Cancer and Squamous Cell Carcinoma of the Oral Cavity, run by Orlando Guntinas-Lichius, Prof. Dr. med. at 4 sites in Germany.

Completed

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

Official record
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Trial summary

A combination therapy of Docetaxel, Cisplatin und 5-Fluorouracil (= TPF) will be used in patients with resectable oropharyngeal and cavity of the mouth cancer. To improve the compatibility of the TPF-induction without decreasing the efficacy the dose will be given on day 1 and 8 instead of applying the whole dose on… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Taxotere, Cisplatin, 5-Fluorouracil (5-FU)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
4 sitesGermany
Study dates
Nov 2009to Feb 2016
Phase
Phase 1/2
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histological proven, resectable squamous epithelial carcinoma of the oropharynx and the cavity of the mouth
  • R0-resection possible
  • All T N2 M0 / all T N3 M0 / if T3 or T4a also N0-1 M0
  • Leucocytes > 4000/mm³ bzw. neutrophils > 2000/mm³, thrombocytes > 100000/mm³
  • adequate kidney function, defined as serum creatinine und urea in normal range, Creatinine clearance > 60 ml/min
  • adequate liver function with glutamate oxaloacetate transaminase (SGOT), glutamate pyruvate transaminase (SGPT) and bilirubin in normal range
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  • electrolytes in normal range
  • risks of anesthesia complications normal or minor increased
  • Eastern Cooperative Oncology Group (ECOG) 0-2 / Karnofsky >= 60%
  • Age 18 - 80 years
  • signed written informed consent
  • effective contraception for both male and female subjects if the risk of conception exists

Who cannot join

  • T1 N0 M0 / T1 N1 M0 / T2 N0 M0 / T2 N1 M0
  • Resection without curative intention: primary tumor is not treatable with resection methods
  • Infiltration of the lower jaw
  • M1 status
  • Tumor not measurable with Innovation Center Computer Assisted Surgery (ICCAS) methods
  • No prior chemotherapy or radiation (a primary surgery is allowed)
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  • Metachronous or oder synchronous malignoma (Exception: basal cell carcinoma)
  • Life expectance < 3 months
  • ECOG > 2; Karnofsky < 60%
  • acute infections or fever
  • known HIV-infection or other immune suppression
  • severe cardio pulmonary concomitant diseases
  • chronic disease with continuous therapy (uncontrolled diabetes, rheumatoid arthritis) especially continuous therapy with steroids
  • other concomitant diseases which, in the investigator's opinion, would exclude the patient from the study
  • Contraindications which permit a therapy with Docetaxel, Cisplatin, 5-FU or radiation therapy
  • missing patient's compliance
  • regular Follow-up visits not possible
  • Pregnancy or lactation period
  • legal incapacity or limited legal capacity
  • Participation in another clinical trial or administration of a not approved substance within 30 days before registration

Trial locations and contacts

4 sites in 1 country.

Germany4 sites

  • Städt. Kliniken Bielefeld gem. GmbH

    Bielefeld, 33604

  • Friedrich-Schiller-University Jena

    Jena, 07740

  • Universitätsklinikum Leipzig - Klinik und Poliklinik für HNO-Heilkunde

    Leipzig, 04103

  • Klinikum Ernst von Bergmann

    Potsdam, 14467

Other trials in Germany

About this study

Official title: Phase I/II Study of Split-dose TPF-Induction Chemotherapy Before Surgery of Oropharyngeal and Cavity of the Mouth Cancer

A combination therapy of Docetaxel, Cisplatin und 5-Fluorouracil (= TPF) will be used in patients with resectable oropharyngeal and cavity of the mouth cancer. To improve the compatibility of the TPF-induction without decreasing the efficacy the dose will be given on day 1 and 8 instead of applying the whole dose on day 1 every 3 weeks.

In the phase I-part of the trial the optimal therapeutic dose of Docetaxel and Cisplatin will be defined.

In the phase II-part the progression-free survival after 2 years will be assessed in patients treated with the optimal therapeutic dose.

Read the detailed description

Local advanced Oropharyngeal and cavity of the mouth Cancer are often treated with a combination of surgery and/or radiation and /or chemotherapy.

Despite of therapy improvement there are only little advances in progression-free survival and overall survival.

Therefore new therapy concepts are needed. The advantage of the induction chemotherapy is the possibility of tumor response assessment during chemotherapy and may present a selection criterion for organ preservation.

In order to minimize the time between chemotherapy and surgery it is important to have an early answer for the tumor response. In this study response will be assessed after the first cycle of chemotherapy. Patients showing no tumor response will be operated at once. The other patients will receive further cycles of chemotherapy.

Toxicity of the induction chemotherapy have to be moderate because surgery should not be delayed.

To improve the tolerance of induction therapy the medication dose isn't given on day 1 every 3 weeks, but is dispersed on day 1 and day 8, q3weeks.

Being tested
Taxotere, Cisplatin, 5-Fluorouracil (5-FU)
Medical subject headings
Oropharyngeal Neoplasms, Squamous Cell Carcinoma of Head and Neck

What participants receive

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

  • Taxotere, Cisplatin, 5-Fluorouracil (5-FU)Drug

    Also called Docetaxel

    Phase 1: Intravenous infusion of 40 mg/m² Taxotere and 40 mg/m² Cisplatin followed by 24 h-infusion of 2000 mg/m² 5-FU on day 1 and day 8 every 3 weeks. If possible an escalation to 50 mg/m² Taxotere and 50 mg/m² Cisplatin can be carried out. Phase 2: Optimal dose of phase 1 will be given.

Study groups in NCT01108042
Study groupRoleWhat they receive
Taxotere, Cisplatin, 5-Fluorouracil (5-FU)ExperimentalPhase 1: Intravenous infusion of 40 mg/m² Taxotere and 40 mg/m² Cisplatin followed by 24 h-infusion of 2000 mg/m² 5-FU on day 1 and day 8 every 3 weeks. If possible an escalation to 50 mg/m² Taxotere and 50 mg/m² Cisplatin can be carried out.
Receives: Drug: Taxotere, Cisplatin, 5-Fluorouracil (5-FU)

What is being measured

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

  1. Determination of progression-free survival after 2 years

    Measured: 24 months

Secondary outcomes (5)

  1. Overall survival after 2 years

    Measured: after 2 years

  2. Determination of the efficacy of the induction therapy

    CT or magnetic resonance tomography (MRT) of the neck region

    Measured: after 1, 12 and 24 months

  3. Function of swallowing according the penetration-aspiration-scale

    assessed according the penetration-aspiration-scale (PAS, Rosenbek et al. 1996) and according measuring after Prosiegel (Prosiegel et al. 2002).

    Measured: 0,1, 6, 12, 18, 24 months

  4. Adverse events as a measure of safety and tolerability

    The number of patients with adverse events will be evaluated. Adverse events will be assessed according Common Terminology Criteria of Adverse Events (CTCAE) v.3.0 and analysed as number per patient and number per cycle.

    Measured: once a week

  5. Quality of life

    European Organisation for Research and Treatment of Cancer (EORTC) Quality of life questionnaire (QLQ) for head and neck cancer patients (HN35) questionnaire filled in by the patients

    Measured: 0,1, 6, 12, 18, 24 months

Timeline

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

  1. First posted21 Apr 2010 (estimated)
  2. Study startNov 2009
  3. Primary completionJan 2016
  4. Study completionFeb 2016

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01108042
Sponsor's protocol ID
TISOC-1
Other IDs
2009-011902-41, 2009
Status last verified
May 2016
First submitted
14 Apr 2010
Last updated
18 May 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Inhestern J, Schmalenberg H, Dietz A, Rotter N, Maschmeyer G, Jungehulsing M, Grosse-Thie C, Kuhnt T, Gorner M, Sudhoff H, Wittekindt C, Guntinas-Lichius O. A two-arm multicenter phase II trial of one cycle chemoselection split-dose docetaxel, cisplatin and 5-fluorouracil (TPF) induction chemotherapy before two cycles of split TPF followed by curative surgery combined with postoperative radiotherapy in patients with locally advanced oral and oropharyngeal squamous cell cancer (TISOC-1). Ann Oncol. 2017 Aug 1;28(8):1917-1922. doi: 10.1093/annonc/mdx202.

    PubMed 28498880

  • Inhestern J, Oertel K, Stemmann V, Schmalenberg H, Dietz A, Rotter N, Veit J, Gorner M, Sudhoff H, Junghanss C, Wittekindt C, Pachmann K, Guntinas-Lichius O. Prognostic Role of Circulating Tumor Cells during Induction Chemotherapy Followed by Curative Surgery Combined with Postoperative Radiotherapy in Patients with Locally Advanced Oral and Oropharyngeal Squamous Cell Cancer. PLoS One. 2015 Jul 17;10(7):e0132901. doi: 10.1371/journal.pone.0132901. eCollection 2015.

    PubMed 26186556

  • Oertel K, Spiegel K, Schmalenberg H, Dietz A, Maschmeyer G, Kuhnt T, Sudhoff H, Wendt TG, Guntinas-Lichius O. Phase I trial of split-dose induction docetaxel, cisplatin, and 5-fluorouracil (TPF) chemotherapy followed by curative surgery combined with postoperative radiotherapy in patients with locally advanced oral and oropharyngeal squamous cell cancer (TISOC-1). BMC Cancer. 2012 Oct 20;12:483. doi: 10.1186/1471-2407-12-483.

    PubMed 23083061

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Taxotere, Cisplatin, 5-Fluorouracil (5-FU) in people with Oropharynx Cancer and Squamous Cell Carcinoma of the Oral Cavity, run by Orlando Guntinas-Lichius, Prof. Dr. med. at 4 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 12 inclusion and 20 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 18 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Determination of progression-free survival after 2 years (time frame: 24 months). 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 NCT01108042, which also lists 3 linked publications.

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 18 May 2016.

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