Clinical trial NCT02348450: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Small Cell Lung Cancer
Lead sponsor: Guangdong Association of Clinical Trials
Sponsor class: OTHER
First posted: 2015-01-28
Enrollment: 308
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: Progression free survival of first line therapy
timeFrame: 24 months
Secondary outcomes:
measure: Overall survival
timeFrame: 36 months
measure: Objective Response Rate
timeFrame: 24 months
measure: Number of patients experience adverse events
timeFrame: 36 months
measure: Progression free survival of second line therapy
timeFrame: 24 months
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of AnHui Medical University
state: Anhui
city: Fuzhou
country: China
facility: FuJian Provincial Tumor Hospital
state: Fujian
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
city: Nanning
country: China
facility: Cancer Hospital Affiliated To GuangXi Medical University
state: Guangxi
city: Shijiazhuang
country: China
facility: Fourth hospital of hebei medical university
state: Hebei
city: Haerbin
country: China
facility: The First Affiliated Hospital of HaErBin Medical University
state: Heilongjiang
city: Zhengzhou
country: China
facility: HeNan Provincial Tumor Hospital
state: Henan
city: WuHan
country: China
facility: WuHan Tongji Hospital
state: Hubei
city: Changsha
country: China
facility: HuNan Provincial Tumor Hospital
state: Hunan
city: Nanjing
country: China
facility: JiangSu Provincial Tumor Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of NanChang University
state: Jiangxi
city: Shenyang
country: China
facility: LiaoNing Provincial Tumor Hospital
state: Liaoning
city: Jinan
country: China
facility: ShanDong Provincial Tumor Hospital
state: Shandong
city: Linyi
country: China
facility: Linyi cancer hospital
state: Shandong
city: Shanghai
country: China
facility: Changhai Hospital of Shanghai
state: Shanghai
city: Shanghai
country: China
facility: East Hospital Affiliated To Tongji University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Chest hospital of Shanghai Jiaotong University
state: Shanghai
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: The second affiliated hospital of zhejiang university school of medicine
state: Zhejiang
city: Hangzhou
country: China
facility: ZheJiang Provincial Tumor Hospital
state: Zhejiang
Study officials:
affiliation: Shanghai Chest hospital of Shanghai Jiaotong University
name: Shun Lu, M.D
role: PRINCIPAL_INVESTIGATOR
References: