.A clinical trial to study the effects, (side effects and efficacy) of two combinations of chemotherapy drugs, (Paclitaxel, ifosfamide and Cisplatin) with (Paclitaxel, cisplatin and 5-FU) in patients with LocallyAdvanced Head and Neck Cancer
- Registration Number
- CTRI/2007/091/000013
- Lead Sponsor
- Indian Cooperative Oncology Network ICO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Signed written informed consent
1) Patients must be willing and able to give written informed consent.
Target population
2) Patients with histologically proven undifferentiated carcinoma or squamous cell
carcinoma (except thyroid cancer) of the oral cavity, nasopharynx, oropharynx,
hypopharynx, nasal cavity, paranasal sinus, or larynx
3) Patients with locally advanced, Stage III-IV (except M1), head and neck cancer.
4) Patients with at least one measurable lesion according to the RECIST criteria
(Section 7.3.2.1).
5) Patients who have not been previously treated for head and neck cancer (surgery,
radiation, and chemotherapy, etc)
6) Patients with ECOG Performance status of 0 - 1 (Appendix 3)
7) Patients with normal hematologic, hepatic, and renal function as defined by the
following criteria:
−Neutrophil count: ≥1,500/L
−Platelet count: ≥100,000/L
−Hemoglobin amount: ≥9.0 g/dL
−Serum AST and serum ALT: ≤2.5 x upper normal limit of the each site serum
total bilirubin: ≤1.25 x upper normal limit of each site
−Serum creatinine: ≤upper normal limit of each site (in case of values above the
upper normal limit, refer to the Calculated Creatinine Clearance 60 ml/min (see
Appendix 6)
8) Patients with a life expectancy of at least 3 months.
9) Men and Women, with ages ranging from 18 to 75 years.
Women of child bearing potential (WOCBP) must have a negative serum or urine
pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within
72 hours prior to the start of study medication. WOCBP include any female who has
experienced menarche and who has not undergone successful surgical sterilization
(hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not
postmenopausal [defined as amenorrhea ≥12 consecutive months; or women on hormone
replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH)
level 35 mIU/mL]. Even women who are using oral, implanted or, injectable
contraceptive hormones or mechanical products such as an intrauterine device or barrier
methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing
abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of
child bearing potential.
Sex and Reproductive Status Exceptions
1) WOCBP who are unwilling or unable to use an acceptable method to avoid
pregnancy for the entire study period and for up to 4 weeks after the study.
2) Women who are pregnant or breastfeeding
3) Women with a positive pregnancy test on enrollment or prior to study drug
administration.
4) Sexually active males unwilling to practice contraception during the study
Medical History and Concurrent Diseases
5) Patients with a history of another malignancy (except cured basal cell carcinoma of
skin or cured carcinoma in-situ of uterine cervix)
6) Patients with organ allografts (kidney, liver, heart, and lung, etc)
7) Patients with clinically significant cardiac disease (e.g. congestive heart failure,
symptomatic coronary artery disease and cardiac arrhythmias) not well controlled
with medication) or a myocardial infarction within the last 6 months
8) Patients with evidence of central nervous system metastases.
9) Patients with a history of uncontrolled seizures, central nervous system disorders or
psychiatric disabilities that may preclude adequate informed consent or compromise
compliance with treatment, as judged by the investigator.
10) Patients with serious uncontrolled inter-current infections or HIV infection.
11) Patients with active gastrointestinal bleeding.
12) Patients who have undergone major surgery within 4 weeks of the start of study
treatment.
13) Patients with pre-existing neuropathy ≥ CTC grade 2 (Appendix 4)
Allergies and Adverse Drug Reactions
14) Patients with a history of hypersensitivity related to the administration of
polyoxyethylene-castor-oil (Cremophor EL)(e.g., cyclosporin), or hardened castor
oil (e.g., vitamin preparations for injection, etc).
15) Patients who received other investigational drug(s) within 6 months prior to study
enrolment.
16) Patients that the investigator judges as inappropriate to participate in this study.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate and compare the toxicity of TIP and TCF regimens when used in locally advanced HNC in neoadjuvant setting. <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: To evaluate and compare the toxicity of TIP and TCF regimens when used in locally advanced HNC in neoadjuvant setting. <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method To assess the tumor response of TIP and TCF in this population of patients.Timepoint: To assess the tumor response of TIP and TCF in this population of patients.