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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2010 by Rabin Medical Center
Sponsor:
Collaborator:
Davidoff Cancer Center
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01073683
First received: January 12, 2010
Last updated: March 3, 2010
Last verified: February 2010
  Purpose

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 Intervention Phase
Larynx Cancer
Procedure: laryngoscopy
Drug: Taxotere (Docetaxel), Cisplatin, 5FU
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Improvement in larynx preservation free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in overall survival in patients treated under this regimen in comparison to historical control [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01073683

Contacts
Contact: Aron Popovtzer, md 97239378044 aronp@clalit.org.il
Contact: Raphael Feinmesser, md 97239376453 feinmesserr@clalit.org.il

Locations
Israel
Rabin MC Not yet recruiting
Petach Tikva, Israel, 49100
Contact: Aron Popovtzer, MD    039378004    aronp@clalit.org.il   
Contact: Salomon Stemmer, MD    039378023    sstemmer@clalit.org.il   
Principal Investigator: Aron Popovtzer, MD         
Sponsors and Collaborators
Rabin Medical Center
Davidoff Cancer Center
Investigators
Principal Investigator: Aron Popovtzer, MD Rabin MC
  More Information

No publications provided

Responsible Party: Aron Popovtzer senior doctor, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01073683     History of Changes
Other Study ID Numbers: RMC5476
Study First Received: January 12, 2010
Last Updated: March 3, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Rabin Medical Center:
TPF
INDUCTION CHEMOTHERAPY
LARYNX PRESERVATION
SUPACRICOID LARYNGECTOMY
Stage 3 and 4 larynx cancer

Additional relevant MeSH terms:
Cisplatin
Docetaxel
Fluorouracil
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014