Clinical Trials /

Irinotecan Plus Cisplatin Compared With Etoposide Plus Cisplatin for Extensive Stage Small-cell Lung Cancer

NCT02348450

Description:

This study is aimed to evaluate the progression-free survival(PFS) and also survival of IP and EP (head-to-head) as the first line therapy for extensive stage small-cell lung cancer and to explore the reasonable first-line therapy for Chinese population. An open-label, multi-center study will be conducted with dynamic randomization of approximately 1:1 ratio with an estimation of 308 eligible participants.

Related Conditions:
  • Small Cell Lung Carcinoma
Recruiting Status:

Unknown status

Phase:

Phase 4

Trial Eligibility

Document

Title

  • Brief Title: Irinotecan Plus Cisplatin Compared With Etoposide Plus Cisplatin for Extensive Stage Small-cell Lung Cancer
  • Official Title: Irinotecan Plus Cisplatin Compared With Etoposide Plus Cisplatin for Extensive Stage Small-cell Lung Cancer: a Multi-center, Randomized, Open Label Study

Clinical Trial IDs

  • ORG STUDY ID: CTONG1404
  • NCT ID: NCT02348450

Conditions

  • Small Cell Lung Cancer

Interventions

DrugSynonymsArms
IrinotecanAi LiIrinotecan plus Cisplatin
EtoposideH32025583Etoposide plus Cisplatin
CisplatinNuo XinIrinotecan plus Cisplatin

Purpose

This study is aimed to evaluate the progression-free survival(PFS) and also survival of IP and EP (head-to-head) as the first line therapy for extensive stage small-cell lung cancer and to explore the reasonable first-line therapy for Chinese population. An open-label, multi-center study will be conducted with dynamic randomization of approximately 1:1 ratio with an estimation of 308 eligible participants.

Detailed Description

      evaluate the progression-free survival(PFS) and also survival of IP and EP (head-to-head) as
      the first line therapy for extensive stage small-cell lung cancer and to explore the
      reasonable first-line therapy for Chinese population.

      An open-label, multi-center study will be conducted with dynamic randomization of
      approximately 1:1 ratio with an estimation of 308 eligible participants.
    

Trial Arms

NameTypeDescriptionInterventions
Irinotecan plus CisplatinExperimentalfirst line: irinotecan 65mg/m2 d1,8. Cisplatin 30mg/m2,d1,8, 21days/cycle×6 cycles Second-line: etoposide alone OR etoposide plus cisplatin, dosage will be same as first line or on investigator's discretion.
  • Irinotecan
  • Cisplatin
Etoposide plus CisplatinExperimentalfirst line: etoposide 60mg/m2 d1-5 Cisplatin 75mg/m2,d1(recommended), or administer three times with same total daily dose , 21days/cycle×6 cycles Second-line: irinotecan alone or irinotecan plus cisplatin, dosage is same as first line or on investigator's discretion.
  • Etoposide
  • Cisplatin

Eligibility Criteria

        Inclusion Criteria:

          -  Cytologically or histologically confirmed extensive stage small-cell lung cancer
             (remote metastasis and/or contralateral lymph-node involvement; not those with simple
             ipsilateral pleural effusion);

          -  No prior radiotherapy, chemotherapy or surgery;

          -  At least one measurable lesion, CT≥20mm, spiral CT≥10mm(diameter);

          -  ECOG PS 0-1;

          -  Age 18-70;

          -  Life expectancy > three months;

          -  In general normal function of heart, liver, kidney and bone marrow;

          -  WBC C>4.0×10(9)/L, NEUT>1.50×10(9)/L, PLT>100×10(9)/L, Hb>95g/L;

          -  Liver function: TBIL < 1.5 x UL normal range; ALT and AST < 1.5 x UL normal range;

          -  Kidney function: normal serum creatinine level;

          -  Signed an informed consent and will comply with the study protocol and follow-up
             plans.

        Exclusion Criteria:

          -  Failed to meet the entry criteria of pathology and clinical stage;

          -  Have received prior chemotherapy or target treatment;

          -  Currently receiving other anticancer therapy;

          -  No measurable lesions or lesions cannot be assessed;

          -  Patients with acute or chronic medical or psychiatric condition, or laboratory
             abnormalities that may impact the judgment of the investigator and the result of the
             study, determined by investigator they may include:

        Uncontrolled tumor metastasis in central nerve system; Uncontrolled hypertension, unstable
        angina, MI history, or congestive heart-failure, uncontrolled arrhythmia, ischemic vascular
        disease within the 12 months prior to study treatment; Myocardial ischemia by ECG or
        valvular heart disease; Grade 3 or above peripheral neuropathy; Active stage of infection
        by bacteria, fungi or virus; Pregnant or breast feeding woman; History of uncontrolled
        mental disease.

          -  Not able to discontinue NSAIDs treatment;

          -  Other active malignant tumors except non-melanoma skin cancer, in-situ cervical
             carcinoma and cured early prostatic carcinoma;

          -  Patients with allergies, known or may be allergic to drugs in research;

          -  Patients with poor compliance to treatment and follow-up;

          -  Patients with UGT1A1-6 and UGT1A1-28 gene mutation;

          -  With clinical symptoms of brain metastasis(patient with stable clinical performance
             and no need to treat can be included in the trial);

          -  Chest, abdominal or pericardial effusion that needs anti-cancer intervention;

          -  Accompanied with Grade ≥2 diarrhea;

          -  Participated in other clinical trials within one month before randomization;

          -  Investigator's judgment to exclude.
      
Maximum Eligible Age:70 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression free survival of first line therapy
Time Frame:24 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Overall survival
Time Frame:36 months
Safety Issue:
Description:
Measure:Objective Response Rate
Time Frame:24 months
Safety Issue:
Description:
Measure:Number of patients experience adverse events
Time Frame:36 months
Safety Issue:
Description:
Measure:Progression free survival of second line therapy
Time Frame:24 months
Safety Issue:
Description:

Details

Phase:Phase 4
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Guangdong Association of Clinical Trials

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