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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


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Squamous Cell Carcinoma of the Hypopharynx, Larynx Carcinoma

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Trial Information

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


Inclusion Criteria:



- 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

- 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)

Exclusion Criteria:

- 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

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

LFS-rate 2 years after randomisation

Safety Issue:

Yes

Principal Investigator

Andreas Dietz, Dr. med.

Investigator Role:

Study Director

Investigator Affiliation:

University of Leipzig

Authority:

Germany: Paul-Ehrlich-Institut

Study ID:

TP(F)+Radiation+/-Cetuximab

NCT ID:

NCT00508664

Start Date:

July 2007

Completion Date:

Related Keywords:

  • Squamous Cell Carcinoma of the Hypopharynx
  • Larynx Carcinoma
  • by laryngectomy operable carcinoma of the larynx and the hypopharynx
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Laryngeal Diseases
  • Hypopharyngeal Neoplasms
  • Laryngeal Neoplasms

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