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.
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
Interventions
Drug | Synonyms | Arms |
---|
Irinotecan | Ai Li | Irinotecan plus Cisplatin |
Etoposide | H32025583 | Etoposide plus Cisplatin |
Cisplatin | Nuo Xin | Etoposide 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
Name | Type | Description | Interventions |
---|
Irinotecan plus Cisplatin | Experimental | first 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. | |
Etoposide plus Cisplatin | Experimental | first 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. | |
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: | Unknown status |
Lead Sponsor: | Guangdong Association of Clinical Trials |
Last Updated
December 5, 2016