Detecting Chemosensitivity and Predicting Treatmemt Efficacy With CTCs in mNPC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: cisplatin-based chemotherapy.
- Who it may be relevant to
- Registry conditions: Circulating Tumor Cell, Nasopharyngeal Carcinoma, Distant Metastases.Clinical, Effects of Chemotherapy. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Detecting Chemosensitivity and Predicting Treatmemt Efficacy With Circulating Tumour Cells From Peripheral Blood in Metastatic Nasopharyngeal Carcinoma Patients
Overview
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
- Drug cisplatin-based chemotherapy
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 cy
Primary outcome measures
- The coincidence rate between drug sensitivity test in CTCs and objective response rate [Time frame: 6 months]
Secondary outcome measures (5)
- The changes of CTCs countings [Time frame: Change from pre-chemotherapy to 22-28(±7) days after last course of chemotherapy]
- Objective response rate [Time frame: study period of 19 Months]
- Progression free survival [Time frame: baseline]
- Cutoff value of CTC counts [Time frame: Objective response at 6 months]
- Predictive value of the changes of CTCs countings [Time frame: Change from pre-chemotherapy to 22-28(±7) days after last course of chemotherapy]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
China · 1 center
- Cancer Center, Sun Yat-sen University — Guangzhou
Identifiers
NCT: NCT04544969 · B2019-128