Phase II trial of neoadjuvant therapy with paclitaxel and carboplatin in operable locally advanced head and neck cancer patients (NEOS)
- Conditions
- Neoplasms
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 79
1. A patient whose potentially surgical, teletransfer-free HNSCC of oral, hypodermic, occipital, and larynx has been tissue-confirmed
Oral cancer of III-IV, laryngeal cancer, hypodermic cancer, HPV-negative head cancer
II-III HPV positive head cancer
A disease that can be measured, defined as a lesion that can be accurately measured pursuant to RECIST 1.1
3. Where the candidate subject to the test prepares the consent of the person subject to the test after obtaining approval required by region before the commencement of any plan-related procedures, including screening evaluation
4. Adult men and women over 20 years old at the time of participation in clinical trials
5. Eastern Cancer Cooperation Research Group (Eastern Cooperative Oncology Group, ECOG) Activity Status 0 or 1
6. A patient with a life expectancy of at least 12 weeks
7. Proper and normal organ and bone marrow functions as defined below:
-hemoglobin test 9.0 g/dL
Absolute neutropenic number (ANC) set 109/L (1500 per mm3)
Platelet count 75,000 per mm3
1.5 times the total ULN of serum bilubine test institution
- 2.5 times the ULN of the AST (SGOT)/ALT (SGPT) test institute.
Creatinine cleaning rate calculated by 40 mL/min or Cockcroft Gault formula (Cockcroft and Gault 1976) measured by 24-hour urine collection samples > 40 mL/min:
8. Women who have evidence after menopause or pre-menopausal women whose urine or serum pregnancy test results are negative. Women who have amenorrhea for 12 months without other medical reasons are considered after menopause. The following age requirements apply:
Even under the age of 50, she is in amenorrhea for at least 12 months after discontinuing exogenous hormone treatment, and if the gechromal hormone (LH) and follicle stimulating hormone (FSH) levels are the menopause levels of the test institute, or if she underwent a surgical infertility operation (bilateral ovarian resection or complete hysterectomy), she is considered a menopause woman.
- Women who have been in amenorrhea for at least 12 months after stopping all external hormone treatment, or whose last menstrual period is at least a year before and after radiation-induced menopause, or more than a year after chemotherapy induced menopause or who have undergone surgical infertility (bilateral ovarian resection, bilateral tubulectomy, or full hysterectomy) are considered women with menopause.
1. Direct involvement in the planning and/or implementation of this clinical trial
2. Patients with nasopharyngeal cancer
3. A patient who has experienced previous treatment for head and neck cancer (including a history of radiation treatment)
4. Patients who have participated in other clinical trials using clinical drugs within the past month
5. A patient registered simultaneously in a clinical trial other than an observation (non-mediate) clinical trial or an intermediary clinical trial tracer
6. Patients who need to use additional chemotherapy, clinical medicine, biological medicine, or hormone therapy for chemotherapy: Provided, That the simultaneous use of hormone therapy (e.g. hormone replacement therapy) for conditions unrelated to cancer is allowed.
7. The toxicity of at least NCI CTCAE Level 2 of the previous anti-cancer treatment, which has not yet been resolved: Provided, That laboratory values defined as hair loss, vitiligo, and selection criteria shall be excluded.
Neuropathy of grade 2 or higher is determined after consultation with a clinical trial doctor on a case-by-case basis.
9. Patients with irreversible toxicity that is not expected to worsen due to the administration of clinical trials can participate in the test only after consultation with a clinical trial doctor.
10. Patients who undergo a major operation (according to the tester's definition) within 28 days before the initial administration of clinical medication. Note: Local surgery on independent lesions for the purpose of conventional treatment is acceptable.
11. Intractable diseases, but not limited to the following: ongoing or active infections; symptom congestive heart failure; uncontrolled high blood pressure; unstable angina; heart veins; epileptic lung disease; Major chronic gastrointestinal conditions with diarrhea; All mental/social conditions that may restrict compliance with clinical trial requirements or significantly increase the risk of adverse reactions or hinder the subject's ability to write consent
12. A patient who has a history of another primary malignant tumor: Provided, That the following shall not apply:
A past malignant tumor that was treated for the purpose of complete cure and has no history of a known active disease within five years before the initial administration of clinical medication and has a low risk of recurrence
-non-black skin cancer treated properly or malignant black spots without evidence of disease
Carcinoma that has been properly treated and has no evidence of disease
13. History of active primary immune deficiency
14. Women who are currently pregnant or breastfeeding or fertile men and women who are not willing to use effective contraception from the time of screening to 180 days after the end of clinical treatment
15. Patients who are known to be allergic or irritable to clinical trials drugs or their siblings
16. Patients who are not suitable to participate in clinical trials and are not expected to comply with clinical trial procedures, restrictions, and requirements according to the judgment of the tester
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Major pathologic response(mPR)
- Secondary Outcome Measures
Name Time Method ocoregional relapse rate(LRR);Relapse–free survival(RFS);Overall survival (OS)