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

Small Cell Lung Cancer Clinical Trial

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 Details — Status: Recruiting

Administrative data

• NCT number: NCT02348450
• Other study ID #: CTONG1404
• Status: Recruiting
• Phase: Phase 4
• First received: October 23, 2014
• Last updated: December 2, 2016
• Start date: February 2015
• Est. completion date: December 2018

Study information

• Verified date: December 2016
• Source: Guangdong Association of Clinical Trials
• Contact: Shun Lu, M.D
• Phone: 86-13601813062
• Email: shun_lu[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 308
• Est. completion date: December 2018
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• Irinotecan
40mg
• Etoposide
5ml:0.1g
• Cisplatin
6ml:30mg

Locations

Country	Name	City	State
China	HuNan Provincial Tumor Hospital	Changsha	Hunan
China	FuJian Provincial Tumor Hospital	Fuzhou	Fujian
China	Guangdong General Hospital	Guangzhou	Guangdong
China	The First Affiliated Hospital of HaErBin Medical University	Haerbin	Heilongjiang
China	Hangzhou First People's Hospital	Hangzhou	Zhejiang
China	The second affiliated hospital of zhejiang university school of medicine	Hangzhou	Zhejiang
China	ZheJiang Provincial Tumor Hospital	Hangzhou	Zhejiang
China	The First Affiliated Hospital of AnHui Medical University	Hefei	Anhui
China	ShanDong Provincial Tumor Hospital	Jinan	Shandong
China	Linyi cancer hospital	Linyi	Shandong
China	The First Affiliated Hospital of NanChang University	Nanchang	Jiangxi
China	JiangSu Provincial Tumor Hospital	Nanjing	Jiangsu
China	Cancer Hospital Affiliated To GuangXi Medical University	Nanning	Guangxi
China	Changhai Hospital of Shanghai	Shanghai	Shanghai
China	East Hospital Affiliated To Tongji University	Shanghai	Shanghai
China	Shanghai Chest hospital of Shanghai Jiaotong University	Shanghai	Shanghai
China	LiaoNing Provincial Tumor Hospital	Shenyang	Liaoning
China	Fourth hospital of hebei medical university	Shijiazhuang	Hebei
China	WuHan Tongji Hospital	WuHan	Hubei
China	HeNan Provincial Tumor Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Association of Clinical Trials

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival of first line therapy		24 months	No
Secondary	Overall survival		36 months	No
Secondary	Objective Response Rate		24 months	No
Secondary	Number of patients experience adverse events		36 months	Yes
Secondary	Progression free survival of second line therapy		24 months	No