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

December 30, 2015 updated by: Yi-Long Wu, Guangdong Association of Clinical Trials

Nedaplatin/Docetaxel Versus Cisplatin/Docetaxel in Treatment of Advanced/Relapsed Squamous Cell Lung Cancer :A Randomized, Open, Parallel, Multicentre, Phase Ⅲ Study

To compare the efficacy and safety of docetaxel plus nedaplatin with docetaxel plus cisplatin in managment of advanced/relapsed squamous cell lung cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

488

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences
        • Contact:
          • Yi-Long Wu, MD
          • Phone Number: 51221 +86 20 83827812
          • Email: syylwu@live.cn
        • Principal Investigator:
          • Yi-Long Wu, MD
        • Contact:
        • Sub-Investigator:
          • Haiyan Tu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PFS
Time Frame: 30 months
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Association of Clinical Trials

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

December 29, 2015

First Submitted That Met QC Criteria

December 30, 2015

First Posted (Estimate)

December 31, 2015

Study Record Updates

Last Update Posted (Estimate)

December 31, 2015

Last Update Submitted That Met QC Criteria

December 30, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTONG1501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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