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An Open, Randomized, Multicentre, Phase II Pilot Study

Primary Purpose

Non-Small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Docetaxel
Docetaxel
Sponsored by
Central European Cooperative Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring NSCLC, Docetaxel

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: histologically documented NSCLC stage I-II Complete resection of tumor amd resection margins microscopically tumor free. Surgical procedure: According to necessity for oncology radicality a lobectomy, bilobectomy or pneumectomy will be performed with either radical mediastinal lymphadenectomy or complete sampling of all relevant lymph node areas. Randomization within 60 days after surgical required. Initial work-up General Conditions: 19-70 years, WHO performance status 0-2, adequate hematological function, adequate renal and hepatic function, negative pregnancy test. Exclusion Criteria: NSCLC stage II-IV, SCLC or alveolar carcinoma Clinical evidence of CNS metastases pregnant and lactating patients past or concurrent history of malignancies other than NSCLC,except for curatively treated non melanoma of the skin or in situ cervical carcinoma or other curatively treated cancer with no evidence of disease for at least five years. prior or concurrent antitumor therapy for NSCLC other than surgery. Concomitant participation in clinical studies of non-approved experimental agents or procedures. major complications after surgery serious concomitant medical conditions psychological,familial, sociological or geographical conditions which do not permit compliance with the study protocol

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Docetaxel

    Comparative arm

    Arm Description

    Docetaxel (Taxotere ) 75 mg/m² as a 1 hour i.v. infusion, followed immediately by cisplatin 75 mg/m² as a 1 hour i.v. infusion, on day 1 every 21 days for 6 cycles. Dose reductions and/or treatment delays or discontinuation of treatment are planned for arm A in case of severe haematological and/or non haematological toxicities. Premedication: Dexamethasone 8 mg p.o. (or any other steroid commonly used) will be given -12 h, -3 h, -1 h before start of docetaxel infusion, then + 12 h, +24 h and + 36 h post infusion. All patients should receive a prophylactic antiemetic premedication to prevent nausea and vomitus, which includes a 5-HT3 antagonist prior to start of each docetaxel infusion. Hyperhydration Patients will require intravenous hydration according to institutional guidelines.

    No chemotherapy will be administered. No specific salvage therapy after progression is defined.

    Outcomes

    Primary Outcome Measures

    to compare the effect on disease free survival of adjuvant docetaxel and cisplatin in patients with completely resected stage I-II non-small cell lung cancer versus observation only

    Secondary Outcome Measures

    to determine the impact on overall survival of adjuvant docetaxel and cisplatin.
    to characterise and quantitate toxicity related to this treatment regimen.
    to compare quality of life of patients on both treatment arms.

    Full Information

    First Posted
    February 16, 2006
    Last Updated
    June 22, 2011
    Sponsor
    Central European Cooperative Oncology Group
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00293085
    Brief Title
    An Open, Randomized, Multicentre, Phase II Pilot Study
    Official Title
    An Open, Randomized, Multicentre, Phase II Pilot Study of Docetaxel and Cisplatin in the Adjuvant Treatment of Non-Small Cell Lung Cancer (NSCLC) Stage I-II
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2001 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    September 2003 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Central European Cooperative Oncology Group

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The objective of this study is to evaluate efficacy, safety and quality of life adjuvant docetaxel-cisplatin chemotherapy versus no adjuvant treatment in patients with completely resected NSCLC Stage I-II.
    Detailed Description
    Open multicentre, centrally randomized, two-arm parallel-group, phase II pilot-study. Duration of the Treatment : Arm A - will be 4-6 cycles Docetaxel 75mg/m2 and Cisplatin 75mg/m2 on day 1 every 21 days. Arm B untreated control group - best supportive care. A follow-up check-up examination will be performed every 3 months for a total of three years.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-Small Cell Lung Cancer
    Keywords
    NSCLC, Docetaxel

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    37 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Docetaxel
    Arm Type
    Active Comparator
    Arm Description
    Docetaxel (Taxotere ) 75 mg/m² as a 1 hour i.v. infusion, followed immediately by cisplatin 75 mg/m² as a 1 hour i.v. infusion, on day 1 every 21 days for 6 cycles. Dose reductions and/or treatment delays or discontinuation of treatment are planned for arm A in case of severe haematological and/or non haematological toxicities. Premedication: Dexamethasone 8 mg p.o. (or any other steroid commonly used) will be given -12 h, -3 h, -1 h before start of docetaxel infusion, then + 12 h, +24 h and + 36 h post infusion. All patients should receive a prophylactic antiemetic premedication to prevent nausea and vomitus, which includes a 5-HT3 antagonist prior to start of each docetaxel infusion. Hyperhydration Patients will require intravenous hydration according to institutional guidelines.
    Arm Title
    Comparative arm
    Arm Type
    No Intervention
    Arm Description
    No chemotherapy will be administered. No specific salvage therapy after progression is defined.
    Intervention Type
    Drug
    Intervention Name(s)
    Docetaxel
    Intervention Type
    Drug
    Intervention Name(s)
    Docetaxel
    Intervention Description
    Docetaxel (Taxotere) 75 mg/m² as a 1 hour i.v. infusion, followed immediately by cisplatin 75 mg/m² as a 1 hour i.v. infusion, on day 1 every 21 days for 6 cycles. Dose reductions and/or treatment delays or discontinuation of treatment are planned for arm A in case of severe haematological and/or non haematological toxicities. Premedication: Dexamethasone 8 mg p.o. (or any other steroid commonly used) will be given -12 h, -3 h, -1 h before start of docetaxel infusion, then + 12 h, +24 h and + 36 h post infusion. All patients should receive a prophylactic antiemetic premedication to prevent nausea and vomitus, which includes a 5-HT3 antagonist prior to start of each docetaxel infusion. Hyperhydration Patients will require intravenous hydration according to institutional guidelines.
    Primary Outcome Measure Information:
    Title
    to compare the effect on disease free survival of adjuvant docetaxel and cisplatin in patients with completely resected stage I-II non-small cell lung cancer versus observation only
    Secondary Outcome Measure Information:
    Title
    to determine the impact on overall survival of adjuvant docetaxel and cisplatin.
    Title
    to characterise and quantitate toxicity related to this treatment regimen.
    Title
    to compare quality of life of patients on both treatment arms.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: histologically documented NSCLC stage I-II Complete resection of tumor amd resection margins microscopically tumor free. Surgical procedure: According to necessity for oncology radicality a lobectomy, bilobectomy or pneumectomy will be performed with either radical mediastinal lymphadenectomy or complete sampling of all relevant lymph node areas. Randomization within 60 days after surgical required. Initial work-up General Conditions: 19-70 years, WHO performance status 0-2, adequate hematological function, adequate renal and hepatic function, negative pregnancy test. Exclusion Criteria: NSCLC stage II-IV, SCLC or alveolar carcinoma Clinical evidence of CNS metastases pregnant and lactating patients past or concurrent history of malignancies other than NSCLC,except for curatively treated non melanoma of the skin or in situ cervical carcinoma or other curatively treated cancer with no evidence of disease for at least five years. prior or concurrent antitumor therapy for NSCLC other than surgery. Concomitant participation in clinical studies of non-approved experimental agents or procedures. major complications after surgery serious concomitant medical conditions psychological,familial, sociological or geographical conditions which do not permit compliance with the study protocol
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Christoph C. Zielinski, Prof
    Organizational Affiliation
    Univ. Klinik f. Innere Medizin I
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    http://www.cecog.org
    Description
    Related Info

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    An Open, Randomized, Multicentre, Phase II Pilot Study

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