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

NCT01073683 | Unknown Phase 2

• 1 other identifier: RMC5476
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Larynx Cancer

Keywords

TPF; INDUCTION CHEMOTHERAPY; LARYNX PRESERVATION; SUPACRICOID LARYNGECTOMY; Stage 3 and 4 larynx cancer

Outcome Measures

Primary Outcomes (1)

• Improvement in larynx preservation free survival

  5 years

Secondary Outcomes (1)

• Improvement in overall survival in patients treated under this regimen in comparison to historical control

  5 years

Study Arms (1)

larynx preservation

EXPERIMENTAL

Decision between surgery and Chemo-rt according to response to initial induction chemotherapy

Procedure: laryngoscopy; Drug: Taxotere (Docetaxel), Cisplatin, 5FU

Interventions

laryngoscopy PROCEDURE

Treatment of advanced larynx cancer with induction TPF, in order to decide between chemoradiation and laryngeal preservation surgery

Also known as: supracrocoid laryngectomy

larynx preservation

Taxotere (Docetaxel), Cisplatin, 5FU DRUG

Taxotere 75 mg/m2 D1, Cisplatin 75 mg/m2 D1, 5FU 750 mg/m2 D1-4

larynx preservation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Rabin Medical Center: lead
• Davidoff Cancer Center: collaborator

Study Sites (1)

Rabin MC

Petah Tikva, 49100, Israel

Location

MeSH Terms

Conditions

Laryngeal Neoplasms

Interventions

Laryngoscopy; Docetaxel; Cisplatin; Fluorouracil

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Otorhinolaryngologic Surgical Procedures; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Aron Popovtzer, MD

  Rabin MC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aron Popovtzer, md

CONTACT

97239378044; aronp@clalit.org.il

Raphael Feinmesser, md

CONTACT

97239376453; feinmesserr@clalit.org.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 12, 2010
• First Posted: February 23, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2014
• Last Updated: March 5, 2010

Record last verified: 2010-02

Locations

IL (1)