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Paclitaxel (Albumin-bound) Combined With Radiotherapy for the Treatment of Early Stage Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Carcinoma

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Albumin-Bound Paclitaxel
Sponsored by
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Differentiated non-keratinizing carcinoma and undifferentiated non-keratinizing carcinoma confirmed by pathology;
  • The staging is T1-2N0-1M0 (except T1N0M0) (UICC 8th edition);
  • Initial treatment patients who have not received anti-tumor therapy;
  • No history of other malignant tumors;
  • Male or female, aged 18 to 70 years old;
  • Liver and kidney function: total bilirubin ≤ upper limit of normal (ULN); AST and ALT ≤ 2.5 times ULN; alkaline phosphatase ≤ 5 times ULN; creatinine clearance ≥ 80 mL/min;
  • Neutrophil count (ANC) ≥2×109/L, platelet count ≥100×109/L and hemoglobin ≥9 g/dL;
  • No serious heart, lung, liver, kidney and other important organ dysfunction;
  • Karnofsky score ≥70 points;
  • Sign the informed consent form;
  • Able to follow research protocols and follow-up procedures.

Exclusion Criteria:

  • Anti-tumor treatment has been performed, including chemotherapy, radiotherapy, and surgery;
  • Find distant metastases before treatment;
  • Women who are pregnant or breastfeeding;
  • Disagree to sign the informed consent form;
  • Patients who cannot cooperate with regular follow-up due to psychological, social, family and geographic reasons;
  • Simultaneously accept experimental treatment of other clinical research (in the treatment period of clinical research);
  • Known to be allergic to possible chemotherapy drugs;
  • Patients with other malignant tumors;
  • Accompanied by severe uncontrollable infections or medical diseases, including autoimmune diseases;
  • Major organ dysfunction, such as decompensated heart, lung, kidney, and liver failure, cannot tolerate radiotherapy and chemotherapy;
  • Laboratory examination: total bilirubin>upper limit of normal (ULN); AST and/or ALT>1.5 times ULN and accompanied by alkaline phosphatase>2.5 times ULN;
  • Any uncertain factors that affect patient safety or compliance.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Albumin-Bound paclitaxel combined with radiotherapy

    Cisplatin combined with radiotherapy

    Arm Description

    Albumin paclitaxel (100mg/m2), D1 intravenous drip, start the first week of radiotherapy, use it continuously for 4-6 weeks. Radiotherapy: The total dose is 66-70Gy, divided into 33-35 times to complete.

    Cisplatin (40mg/m2), D1 intravenous drip, start the first week of radiotherapy, use it continuously for 4-6 weeks. Radiotherapy: The total dose is 66-70Gy, divided into 33-35 times to complete.

    Outcomes

    Primary Outcome Measures

    Objective response rate
    Nasopharyngeal + neck MRI and nasopharyngoscopy: the nasopharyngeal mass disappeared; the nasopharyngeal mucosa was smooth and no lesions were seen on the nasopharyngoscope. The tumor is clinically considered to have completely subsided. Neck MRI showed complete regression of cervical lymph nodes, or combined with clinical findings that the lymph node lesions completely resolved.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 14, 2021
    Last Updated
    February 22, 2021
    Sponsor
    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04766359
    Brief Title
    Paclitaxel (Albumin-bound) Combined With Radiotherapy for the Treatment of Early Stage Nasopharyngeal Carcinoma
    Official Title
    Paclitaxel (Albumin-bound) Combined With Radiotherapy Compared With Cisplatin Combined With Radiotherapy for the Treatment of Early Stage Nasopharyngeal Carcinoma: a Prospective, Parallel-controlled, Multicenter Phase III Clinical Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2021 (Anticipated)
    Primary Completion Date
    August 1, 2025 (Anticipated)
    Study Completion Date
    August 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This trial is a prospective, parallel controlled, randomized, open, multi-center phase III clinical trial. The trial will enroll 364 patients with nasopharyngeal carcinoma who are staged T1-2N0-1M0 (except T1N0M0) (UICC 8th edition) . This experiment was participated by multiple centers of Nanjing Gulou Hospital, Jiangsu Provincial People's Hospital, Jiangsu Cancer Hospital, Nanjing Military Region General Hospital, Jiangsu Provincial Hospital of Traditional Chinese Medicine, and Zhongda Hospital. Each center competes for admission of cases. The subjects will be randomly assigned (using the random number table method according to the order of entry) to the experimental group to receive albumin-bound paclitaxel combined with IMRT concurrent radiotherapy, or the control group to receive cisplatin combined with IMRT concurrent radiotherapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nasopharyngeal Carcinoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    364 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Albumin-Bound paclitaxel combined with radiotherapy
    Arm Type
    Experimental
    Arm Description
    Albumin paclitaxel (100mg/m2), D1 intravenous drip, start the first week of radiotherapy, use it continuously for 4-6 weeks. Radiotherapy: The total dose is 66-70Gy, divided into 33-35 times to complete.
    Arm Title
    Cisplatin combined with radiotherapy
    Arm Type
    Experimental
    Arm Description
    Cisplatin (40mg/m2), D1 intravenous drip, start the first week of radiotherapy, use it continuously for 4-6 weeks. Radiotherapy: The total dose is 66-70Gy, divided into 33-35 times to complete.
    Intervention Type
    Drug
    Intervention Name(s)
    Albumin-Bound Paclitaxel
    Other Intervention Name(s)
    Cisplatin, Radiotherapy
    Intervention Description
    Compare the effectiveness and safety of paclitaxel (albumin-bound) combined with radiotherapy and cisplatin combined with radiotherapy in the treatment of early nasopharyngeal carcinoma.
    Primary Outcome Measure Information:
    Title
    Objective response rate
    Description
    Nasopharyngeal + neck MRI and nasopharyngoscopy: the nasopharyngeal mass disappeared; the nasopharyngeal mucosa was smooth and no lesions were seen on the nasopharyngoscope. The tumor is clinically considered to have completely subsided. Neck MRI showed complete regression of cervical lymph nodes, or combined with clinical findings that the lymph node lesions completely resolved.
    Time Frame
    1month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Differentiated non-keratinizing carcinoma and undifferentiated non-keratinizing carcinoma confirmed by pathology; The staging is T1-2N0-1M0 (except T1N0M0) (UICC 8th edition); Initial treatment patients who have not received anti-tumor therapy; No history of other malignant tumors; Male or female, aged 18 to 70 years old; Liver and kidney function: total bilirubin ≤ upper limit of normal (ULN); AST and ALT ≤ 2.5 times ULN; alkaline phosphatase ≤ 5 times ULN; creatinine clearance ≥ 80 mL/min; Neutrophil count (ANC) ≥2×109/L, platelet count ≥100×109/L and hemoglobin ≥9 g/dL; No serious heart, lung, liver, kidney and other important organ dysfunction; Karnofsky score ≥70 points; Sign the informed consent form; Able to follow research protocols and follow-up procedures. Exclusion Criteria: Anti-tumor treatment has been performed, including chemotherapy, radiotherapy, and surgery; Find distant metastases before treatment; Women who are pregnant or breastfeeding; Disagree to sign the informed consent form; Patients who cannot cooperate with regular follow-up due to psychological, social, family and geographic reasons; Simultaneously accept experimental treatment of other clinical research (in the treatment period of clinical research); Known to be allergic to possible chemotherapy drugs; Patients with other malignant tumors; Accompanied by severe uncontrollable infections or medical diseases, including autoimmune diseases; Major organ dysfunction, such as decompensated heart, lung, kidney, and liver failure, cannot tolerate radiotherapy and chemotherapy; Laboratory examination: total bilirubin>upper limit of normal (ULN); AST and/or ALT>1.5 times ULN and accompanied by alkaline phosphatase>2.5 times ULN; Any uncertain factors that affect patient safety or compliance.

    12. IPD Sharing Statement

    Learn more about this trial

    Paclitaxel (Albumin-bound) Combined With Radiotherapy for the Treatment of Early Stage Nasopharyngeal Carcinoma

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