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Induction Docetaxel/Cisplatin/5-fluorouracil (TPF) as Selector for Chemo Radiation Therapy (RT) Versus Partial Laryngectomy in Advanced Laryngeal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01073683
Recruitment Status : Unknown
Verified February 2010 by Rabin Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : February 23, 2010
Last Update Posted : March 5, 2010
Davidoff Cancer Center
Information provided by:
Rabin Medical Center

Brief Summary:
Treatment of patients with one cycle of induction chemotherapy to select for organ preservation of the larynx has been proven as a standard approach. When compared to historical controls. The investigators propose to study patients with a similar treatment strategy (i.e. one cycle of induction chemotherapy followed by two more chemotherapy cycles, in advanced nodal disease, followed by chemoradiation for those responding to the initial chemotherapy. Those who fail to respond or fail in radiation will directly undergo surgery. The novelty of the proposed study is that non responders and failures will be given the opportunity of larynx preserving supracricoid laryngectomy. The investigators will attempt to reduce toxicity from induction chemotherapy and improve potency with the use of docetaxel/cisplatin/5-fluorouracil (TPF) in place of the standard regimen of cisplatin and 5-fluorouracil (PF). Emerging data demonstrates that induction regimens containing triplets with platinum, 5-fluorouracil, and taxanes produce higher response rates and less overall toxicity when compared to induction strategies utilizing PF

Condition or disease Intervention/treatment Phase
Larynx Cancer Procedure: laryngoscopy Drug: Taxotere (Docetaxel), Cisplatin, 5FU Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Organ Preservation Trial Using Cisplatin Concomitant With Radiation Therapy in Advanced Laryngeal Cancer Patients Who Have Responded to Induction Chemotherapy With Taxotere, Cisplatin, and 5-Fluorouracil (TPF)
Study Start Date : April 2010
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: larynx preservation
Decision between surgery and Chemo-rt according to response to initial induction chemotherapy
Procedure: laryngoscopy
Treatment of advanced larynx cancer with induction TPF, in order to decide between chemoradiation and laryngeal preservation surgery
Other Name: supracrocoid laryngectomy

Drug: Taxotere (Docetaxel), Cisplatin, 5FU
Taxotere 75 mg/m2 D1, Cisplatin 75 mg/m2 D1, 5FU 750 mg/m2 D1-4

Primary Outcome Measures :
  1. Improvement in larynx preservation free survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Improvement in overall survival in patients treated under this regimen in comparison to historical control [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must have pathologically confirmed previously untreated, resectable, squamous cell carcinoma of the larynx.
  • Disease must be Stage III or IV.
  • Tumor must be potentially surgically resectable and curable with conventional surgery and radiation therapy.
  • Patients must undergo pre-treatment endoscopic tumor staging and CT scanning of chest and neck.(pet scan optional)
  • Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
  • Pre-treatment laboratory criteria:

    • WBC > 3500/ul, granulocyte > 1500/ul.
    • Platelet count > 100,000/ul.
    • Calculated or measured creatinine clearance > 60 cc/min.
    • AST and ALT < 2.5 X ULN
  • Patients must give documented informed consent to participate in this study.

Exclusion Criteria:

  • Prior head and neck malignancy or active non-head and neck malignancy. Except for cured non-melanoma skin cancer,
  • Prior head and neck radiation.
  • Documented evidence of distant metastases.
  • Active infection.
  • Pregnancy or lactation. Patients must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy.
  • Any medical or psychiatric illness which in the opinion of the principal investigator would compromise the patient's ability to tolerate this treatment.
  • Age < 18 years.
  • Patients with psychiatric/social situations that would limit compliance with study requirements are not eligible.
  • Patients with Grade > 2 peripheral neuropathy.
  • Any history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.

Criteria for supracricoid resection for chemo selection non responders

Inclusion Criteria :

  • At least one functional arytenoids (physical and radiological examinations)
  • Involvement of thyroid cartilage including extrathyroid cartilage extension.

Exclusion criteria:

  • Subglottic extension anteriorly.
  • Pre epiglottic extension.
  • Subglottic extension laterally.
  • Interarytenoid involvement.
  • Two Arytenoids involved.

Criteria for supracricoid resection for Chemoradiation failure:

Inclusion Criteria:

  • At least one functional arytenoid (physical and radiological examinations)
  • Involvement of thyroid cartilage (with no radiological evidence for extra thyroid Extension).

Exclusion Criteria:

  • Extrathyroid cartilage extension.
  • Involvement preepiglottic space.
  • Subglottic extension.
  • Interarytenoid involvement.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01073683

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Contact: Aron Popovtzer, md 97239378044
Contact: Raphael Feinmesser, md 97239376453

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Rabin MC
Petach Tikva, Israel, 49100
Contact: Aron Popovtzer, MD    039378004   
Contact: Salomon Stemmer, MD    039378023   
Principal Investigator: Aron Popovtzer, MD         
Sponsors and Collaborators
Rabin Medical Center
Davidoff Cancer Center
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Principal Investigator: Aron Popovtzer, MD Rabin MC

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Responsible Party: Aron Popovtzer senior doctor, Rabin Medical Center Identifier: NCT01073683    
Other Study ID Numbers: RMC5476
First Posted: February 23, 2010    Key Record Dates
Last Update Posted: March 5, 2010
Last Verified: February 2010
Keywords provided by Rabin Medical Center:
Stage 3 and 4 larynx cancer
Additional relevant MeSH terms:
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Laryngeal Neoplasms
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Respiratory Tract Neoplasms
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs