Circulating Tumor Cell, Distant Metastases.Clinical, Effects of Chemotherapy, Nasopharyngeal Carcinoma
Conditions
Brief summary
The prospective observational clinical study will recruit 50 metastatic nasopharyngeal carcinoma (mNPC) patients, detecting patient's chemosensitivity with the circulating tumor cells (CTCs) from peripheral blood and prdicting patient's treatment efficacy with CTCs dynamic change.
Interventions
GP: cisplatin 80 mg/m2 intravenous infusion on day1, gemcitabine 1000 mg/m2 intravenous infusion on day 1 and 8, both drugs are given every 3 weeks, recommended 6 cycles. TP: cisplatin 75 mg/m2 intravenous infusion in day1, docetaxel 75 mg/m2 intravenous infusion in day 1, both drugs are given every 3 weeks, recommended 6 cycles. PF: cisplatin 100 mg/m2 intravenous infusion in day1, fluorouracil 4000 mg/m2 intravenous infusion in day 1 to 5, both drugs are given every 3 weeks, recommended 6 cycles. TPF: cisplatin 60 mg/m2 intravenous infusion in day1, docetaxel 60 mg/m2 intravenous infusion in day 1, fluorouracil 3000 mg/m2 intravenous infusion in day 1 to 5, both drugs are given every 3 weeks, recommended 6 cycles. Choice of chemotherapy regimen is decided by patient's doctor in charge.
Sponsors
Sun Yat-sen University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* NPC patients with distant metastasis after 3 months of primary radiotherapy, and not suitable for local treatment * At least having one measurable metastatic lesion * All genders，range from 18～70 years old * ECOG score 0 \ 1 * Expected survival time ≥ 3 months * White blood cell(WBC) count ≥ 3×109/L, neutrophile granulocyte(NE) count ≥ 1.5×109/L, hemoglobin(HGB) ≥ 90g/L, platelet(PLT) count ≥ 100×109/L * Alanine aminotransferase (ALT) or aspartate aminotransferase(AST) \< 2.5×upper limit of normal(ULN), bilirubin(BUN) or creatinine(CRE) \< 1.5×ULN, alanine aminotransferase (CCR) ≥ 60ml/min * Inform consent form
Exclusion criteria
* Have or are suffering from other malignant tumors; * Participating in other clinical trials; * Drug or alcohol addition; * Do not have full capacity for civil acts; * Mental disorder; * Pregnancy or lactation; * Severe complication, eg, uncontrolled hypertension.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The coincidence rate between drug sensitivity test in CTCs and objective response rate | 6 months | Comparison the coincidence rate between drug sensitivity test in CTCs and objective response rate of corresponding chemotherapy regime |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The changes of CTCs countings | Change from pre-chemotherapy to 22-28(±7) days after last course of chemotherapy | — |
| Objective response rate | study period of 19 Months | To be determined by measurement of target lesions according to RECIST criteria |
| Progression free survival | baseline | Defined as the time in months from first course of treatment until PD is observed or death occurs due to any cause. |
| Cutoff value of CTC counts | Objective response at 6 months | to identify patients with early relapse (\<6 months) after liver resection as determined by the AUC under the ROC curve |
| Predictive value of the changes of CTCs countings | Change from pre-chemotherapy to 22-28(±7) days after last course of chemotherapy | — |
Countries
China
Contacts
Primary ContactJingjing Miao, M.D
Outcome results
None listed