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Detecting Chemosensitivity and Predicting Treatmemt Efficacy With CTCs in mNPC

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ClinicalTrials.gov Identifier: NCT04544969
Recruitment Status : Recruiting
First Posted : September 10, 2020
Last Update Posted : August 10, 2021
Sponsor:
Information provided by (Responsible Party):
Zhao Chong, Sun Yat-sen University

Study Description
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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.

Condition or disease Intervention/treatment
Circulating Tumor Cell Nasopharyngeal Carcinoma Distant Metastases.Clinical Effects of Chemotherapy Drug: cisplatin-based chemotherapy

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Detecting Chemosensitivity and Predicting Treatmemt Efficacy With Circulating Tumour Cells From Peripheral Blood in Metastatic Nasopharyngeal Carcinoma Patients
Actual Study Start Date : April 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

Groups and Cohorts
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Group/Cohort Intervention/treatment
Chemotherapy
Patients treated with palliative chemotherapy
 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 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.

Other Names:
  • docetaxel and cisplatin
  • fluorouracil and cisplatin
  • docetaxel, fluorouracil and cisplatin
  • gemcitabine and cisplatin


Outcome Measures
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Primary Outcome Measures :
  1. The coincidence rate between drug sensitivity test in CTCs and objective response rate [ Time Frame: 6 months ]
    Comparison the coincidence rate between drug sensitivity test in CTCs and objective response rate of corresponding chemotherapy regime


Secondary Outcome Measures :
  1. The changes of CTCs countings [ Time Frame: Change from pre-chemotherapy to 22-28(±7) days after last course of chemotherapy ]
  2. Objective response rate [ Time Frame: study period of 19 Months ]
    To be determined by measurement of target lesions according to RECIST criteria

  3. Progression free survival [ Time Frame: baseline ]
    Defined as the time in months from first course of treatment until PD is observed or death occurs due to any cause.

  4. Cutoff value of CTC counts [ Time Frame: 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

  5. 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
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
NPC patients with distant metastasis after 3 months of primary radiotherapy
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04544969


Contacts
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Contact: Jingjing Miao, M.D 86-13631355201 miaojingjing90@163.com

Locations
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China, Guangdong
Cancer Center, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Chong Zhao    02087342638    zhaochong@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Chong Zhao, M.D Sun Yat-sen University
More Information
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Additional Information:

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Responsible Party: Zhao Chong, Prof., Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04544969    
Other Study ID Numbers: B2019-128
First Posted: September 10, 2020    Key Record Dates
Last Update Posted: August 10, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Nasopharyngeal Carcinoma
Neoplastic Cells, Circulating
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
 Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Gemcitabine
Cisplatin
Docetaxel
Fluorouracil
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents