Squamous cell carcinoma of the head and neck [SCCHN]. MedDRA version: 9.1 Level: LLT Classification code 10060121 Term: Squamous cell carcinoma of head and neck
Conditions
Interventions
Trade Name: Taxotere
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: DOCETAXEL
CAS Number: 114977-28-5
Concentration unit: mg milligram(s)
Concentration type: equal
Con
Sponsors
Dana Farber Cancer Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically proven squamous cell carcinoma of the head and neck. 2. Primary tumor sites eligible: oral cavity, oropharynx, hypopharynx or larynx. Although they are admittedly of squamous cell types, the following tumors will be excluded because their responsiveness to chemotherapy may differ: tumors of the nasal and paranasal cavities and of the nasopharynx. Oral cavity tumors with mandible invasion are excluded because the tumor biology and management of these tumors is more complex and will likely include upfront surgical resection. Subjects with unknown primary sites will not be eligible for this study. 3. Stage 3 or 4 disease without evidence of distant metastases verified by chest X-Ray, abdominal ultrasound, PET/CT or CAT scan (liver function test abnormalities); bone scan in case of local symptoms. 4. At least one uni- or bidimensionally measurable lesion 5. No previous chemotherapy for any reason and no previous surgery for SCCHN (other than biopsy) are allowed at time of study entry (Prior tonsillectomy is allowed). No radiotherapy to the head and neck area is allowed. Patient who had radiotherapy for other cancers more than 5 years ago may be potential candidates for this trial; however each case must be discussed with the Overall PI, Dr. Robert Haddad. 6. Age > 18 years. 7. WHO performance status of 0 or 1 8. No active alcohol addiction that will interfere with participation in this study, as documented by the caregiver. 9. Signed informed consent prior to beginning protocol specific procedures. 10. Adequate bone marrow, hepatic and renal functions Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant or breast feeding women, or women and men of childbearing potential not willing to use adequate contraception while on treatment and for at least 3 months thereafter. 2. Previous or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma of the skin or other cancer curatively treated by surgery and with no evidence of disease for at least 5 years. Any prior treatment with chemotherapy is an exclusion criterion. 3. Symptomatic peripheral neuropathy > grade 2 by National Cancer Institute Common Toxicity Criteria (NCIC-CTC Version 3.0). 4. Symptomatic altered hearing > grade 2 by NCIC-CTC v3.0 criteria. 5. Other serious illnesses or medical conditions including but not limited to: • Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry • History of significant neurologic or psychiatric disorders including dementia or seizures. • Active clinically significant uncontrolled infection. • Active peptic ulcer disease defined as unhealed or clinically active and clinically significant, as documented by the investigator. • Clinically significant hypercalcemia. • Active drug addiction including cocaine or intravenous drug use defined as occurring within the 6 months preceding diagnosis, which may interfere with study treatment, as documented by investigator. • Chronic Obstructive Pulmonary Disease, defined as being associated with a hospitalization for pneumonia or respiratory decompensation within 12 months of diagnosis. This does not include obstruction from tumor. • Autoimmune disease requiring therapy, prior organ transplant, or HIV infection 6. Patients who experienced an involuntary weight loss of more than 25% of their body weight in the 2 months preceding study entry. 7. Concurrent treatment with any other anticancer therapy. 8. Participation in an investigational trial within 30 days of study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the 3-year survival achieved by Docetaxel/ Cisplatin/ 5-fluorouracil (TPF) based sequential therapy with platinum based chemoradiotherapy in patients with locally advanced squamous cell carcinoma of the head and neck [SCCHN]. ;Secondary Objective: 1. To compare the 2-year progression free survival achieved by Docetaxel/Cisplatin/ 5-fluorouracil (TPF) based sequential therapy with platinum based chemoradiotherapy in patients with locally advanced squamous cell carcinoma of the head and neck [SCCHN]. 2. To compare Survival at 5 years 3. To compare Progression Free Survival at 3 and 5 years 4. To compare the rate of complete response after all therapy 5. To determine and compare site-specific survival within and between each arm. 6. To compare functional organ preservation in each arm 7. To compare the toxicity of each treatment regimen 8. To compare quality of life 9. To establish tissue and germ line correlates of response, local regional control, and distant metastases in each arm. ;Primary end point(s): The primary endpoint is to compare the 3-year survival achieved by Docetaxel/ Cisplatin/ 5-fluorouracil (TPF) based sequential therapy with platinum based chemoradiotherapy in patients with locally advanced SCCHN. | — |
Countries
Germany
Outcome results
None listed