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Nedaplatin/Docetaxel Versus Cisplatin/Docetaxel in Treatment of Advanced/Relapsed Squamous Cell Lung Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2015 by Yi-Long Wu, Guangdong Association of Clinical Trials.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02643407
First Posted: December 31, 2015
Last Update Posted: December 31, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yi-Long Wu, Guangdong Association of Clinical Trials
  Purpose
To compare the efficacy and safety of docetaxel plus nedaplatin with docetaxel plus cisplatin in managment of advanced/relapsed squamous cell lung cancer.

Condition Intervention Phase
Non-Small Cell Lung Cancer Drug: Docetaxel Drug: Nedaplatin Drug: Cisplatin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nedaplatin/Docetaxel Versus Cisplatin/Docetaxel in Treatment of Advanced/Relapsed Squamous Cell Lung Cancer :A Randomized, Open, Parallel, Multicentre, Phase Ⅲ Study

Resource links provided by NLM:


Further study details as provided by Yi-Long Wu, Guangdong Association of Clinical Trials:

Primary Outcome Measures:
  • PFS [ Time Frame: 30 months ]

Estimated Enrollment: 488
Study Start Date: October 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Docetaxel plus Nedaplatin
docetaxel 60mg/m2 and nedaplatin 80mg/m2, d1 every 3 weeks
Drug: Docetaxel
60mg/m2
Drug: Nedaplatin
80mg/m2
Active Comparator: Docetaxel plus Cisplatin
docetaxel 60mg/m2 and cisplatin 75mg/m2, d1 every 3 weeks
Drug: Docetaxel
60mg/m2
Drug: Cisplatin
75mg/m2

Detailed Description:
This study is prospective to evaluate whether the efficacy and safety of docetaxel plus nedaplatin is non-inferior to docetaxel plus cisplatin in managment of advanced/relapsed squamous cell lung cancer.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients were required to be between 18 to 75 years, with histologically or cytologically proven squamous cell carcinoma of the lung, stage ⅢB (unfit for definitive radiotherapy), stage Ⅳ or relapsing;
  2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of zero or one;
  3. life expectancy > 3 months;
  4. No previous history of malignancy (except adequately treated carcinoma-in-situ of the cervix or basal cell carcinoma of the skin or superficial bladder cancer [Ta, Tis & T1]); previously untreated with chemotherapy (eg. gemcitabine, platinum, paclitaxel); no previously systemic therapy on locally advanced and metastatic disease; patients were eligible for participation in the study if they had recurrence or metastasis and became locally advanced or metastatic lung cancer after 12 months treatment with gemcitabine, platinum or paclitaxel regimen in adjuvant or neoadjuvant chemotherapy;
  5. Adequate organ function was required, as evidenced by absolute neutrophil count ≥ 1.5 x 109 /L, platelet count ≥ 100 x109/L, hemoglobin ≥ 90 g/L (9 g/dL);
  6. hepatic enzyme levels ≤ 2.5 x the upper limit of the normal range (ULN), alkaline phosphatase levels ≤ 5.0 x the ULN, total bilirubin levels ≤ 1.5 x the ULN, and serum creatinine levels ≤1.5 mg/dL (or creatinine clearance ≥50 mL/min);
  7. Previous radiotherapy was allowed if it involved <25% of bone marrow and was completed 4 weeks before study entry; Patients must be recovered from acute toxicity before the clinical trials;
  8. Pregnancy test: negative (female only); Women with fertility need pregnancy test (serum or urine) in 7 days before entering the group and the results were negative. Male or female patients with reproduction potential had to use an approved contraceptive method during and for 8 weeks after the end of study treatment.
  9. Patients are judged by researcher to be the compliance of research requirements and follow-up.
  10. All the patients provided their written informed consent before enrollment.
  11. The standard first-line platinum-based regimens according to the clinical practice, and the efficacy was evaluated every two cycles.

Exclusion Criteria:

  1. EGFR positive or ALK positive (patients, the status of EGFR and ALK were unknown due to the detection, were included);
  2. Participation in any clinical research in 4 weeks before the first dosage, except non interventional epidemiological investigation;
  3. Patients with the complications in high risk;
  4. Primary brain tumors or central nervous system (CNS) metastatic carcinoma. The patients who are suspected the CNS metastatic carcinoma should be scanned in 28 days before entering the group. Other malignant disease five years ago (except cone-biopsied carcinoma-in-situ of the cervix or adequately treated basal or squamous cell carcinoma of the skin)
  5. Third-space fluid collection that has the clinical significance, such as ascites or pleural effusion, cannot control through the drainage or other method;
  6. Serious mental retardation or cognitive impairment, psychotic illness, poor compliance, cannot meet and narrate therapy responders;
  7. No eliminated acute or chronic infection, or other serious concomitant diseases;
  8. Serious or uncontrolled concomitant disorders (active infection, ischemic heart diseases, arrhythmia, liver dysfunction, or peripheral nerve disorder);
  9. Patients with bleeding tendency or organ transplant;
  10. Alcohol or drug dependent patients; patients with the chronic administration of adrenal cortical hormone or immunosuppressive; patients with AIDS or other infectious diseases;
  11. Active hepatitis, liver metastasis is over 3/4 of the whole liver;
  12. A history of drug allergy;
  13. The female patients in the reproductive years are unwilling contraception;
  14. Accept other anti-tumor therapy at the same time;
  15. The researchers believe that the patients are not able to complete the entire clinical trial.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02643407


Locations
China, Guangdong
Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Haiyan Tu, MD    +86 20 83827812 ext 50810    thoraciconcology88@163.com   
Contact: Yi-Long Wu, MD    +86 20 83827812 ext 51221    syylwu@live.cn   
Principal Investigator: Yi-Long Wu, MD         
Sub-Investigator: Haiyan Tu, MD         
Sponsors and Collaborators
Guangdong Association of Clinical Trials
  More Information

Publications:

Responsible Party: Yi-Long Wu, MD, Guangdong Association of Clinical Trials
ClinicalTrials.gov Identifier: NCT02643407     History of Changes
Other Study ID Numbers: CTONG1501
First Submitted: December 29, 2015
First Posted: December 31, 2015
Last Update Posted: December 31, 2015
Last Verified: December 2015

Keywords provided by Yi-Long Wu, Guangdong Association of Clinical Trials:
squamous cell carcinoma
nedaplatin
cisplatin
docetaxel

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Nedaplatin
Cisplatin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action