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Elimination of Adjuvant Chemotherapy for Selected Stage II and III Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Radiotherapy
Cisplatin
5-FU
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Cancer focused on measuring adjuvant chemotherapy, NPC

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • (1) biopsy-proven carcinoma of the nasopharynx,
  • (2) AJCC 1997 Stage II (T2aN0, T1-T2aN1) or III (T1-T2aN2) disease,
  • (3) normal renal function (Cr < 1.6 mg/dl),

Exclusion Criteria:

  • open-neck lymph node biopsy
  • previous chemotherapy or radiotherapy to the head and neck region
  • distant metastasis or other malignant diseases except skin cancer

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    CCRT alone

    Arm Description

    External beam radiotherapy > 66 Gy Cisplatin 60 mg/m2 IV D1, 5-FU 600 mg/m2 IV D1-5 at week 1 and 5 of radiotherapy Modified for IMRT: Cisplatin 60 mg/m2 IV D1, 5-FU 600 mg/m2 IV D1-3 at week 1, 4 and 7 of radiotherapy

    Outcomes

    Primary Outcome Measures

    Distant-metastasis-free survival
    percentage of patients who survived and has no distant metastasis

    Secondary Outcome Measures

    overall survival
    percentage of patients who survived
    disease-free survival
    percentage of patients who survived and had no disease recurrence

    Full Information

    First Posted
    May 31, 2017
    Last Updated
    June 2, 2017
    Sponsor
    Sun Yat-sen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03175939
    Brief Title
    Elimination of Adjuvant Chemotherapy for Selected Stage II and III Nasopharyngeal Carcinoma
    Official Title
    Elimination of Adjuvant Chemotherapy for Selected Stage II and III Nasopharyngeal Carcinoma After Concomitant Radiotherapy And Chemotherapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1, 1998 (Actual)
    Primary Completion Date
    December 31, 2008 (Actual)
    Study Completion Date
    December 31, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sun Yat-sen University

    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 study evaluates whether some patients with nasopharyngeal carcinoma but with low risk of distant metastasis can be treated with only radiotherapy and concomitant chemotherapy but without additional adjuvant chemotherapy.
    Detailed Description
    The standard treatment for stage II-III nasopharyngeal carcinoma is radiotherapy with concomitant chemotherapy and adjuvant chemotherapy. A subset of these patients has very low risk for distant metastasis that adjuvant chemotherapy is probably unnecessary. The investigators would like to know if same therapeutic effect and survival rate can be achieved without adjuvant chemotherapy, (i.e. less chemotherapy, same effect)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nasopharyngeal Cancer
    Keywords
    adjuvant chemotherapy, NPC

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    263 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CCRT alone
    Arm Type
    Experimental
    Arm Description
    External beam radiotherapy > 66 Gy Cisplatin 60 mg/m2 IV D1, 5-FU 600 mg/m2 IV D1-5 at week 1 and 5 of radiotherapy Modified for IMRT: Cisplatin 60 mg/m2 IV D1, 5-FU 600 mg/m2 IV D1-3 at week 1, 4 and 7 of radiotherapy
    Intervention Type
    Radiation
    Intervention Name(s)
    Radiotherapy
    Intervention Description
    External beam radiotherapy with curative intent, at least 66 Gy
    Intervention Type
    Drug
    Intervention Name(s)
    Cisplatin
    Other Intervention Name(s)
    CDDP
    Intervention Description
    cisplatin IV injection over 3 hours
    Intervention Type
    Drug
    Intervention Name(s)
    5-FU
    Other Intervention Name(s)
    5-fluorouracil
    Intervention Description
    5-FU IV 24 hours continuous infusion
    Primary Outcome Measure Information:
    Title
    Distant-metastasis-free survival
    Description
    percentage of patients who survived and has no distant metastasis
    Time Frame
    5 years
    Secondary Outcome Measure Information:
    Title
    overall survival
    Description
    percentage of patients who survived
    Time Frame
    5 years
    Title
    disease-free survival
    Description
    percentage of patients who survived and had no disease recurrence
    Time Frame
    5 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: (1) biopsy-proven carcinoma of the nasopharynx, (2) AJCC 1997 Stage II (T2aN0, T1-T2aN1) or III (T1-T2aN2) disease, (3) normal renal function (Cr < 1.6 mg/dl), Exclusion Criteria: open-neck lymph node biopsy previous chemotherapy or radiotherapy to the head and neck region distant metastasis or other malignant diseases except skin cancer
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Skye Hung-Chun Cheng, M.D.
    Organizational Affiliation
    Koo Foundation Sun Yat-Sen Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Elimination of Adjuvant Chemotherapy for Selected Stage II and III Nasopharyngeal Carcinoma

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