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An Open, Randomized, Multicentre, Phase II Pilot Study

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ClinicalTrials.gov Identifier: NCT00293085
Recruitment Status : Completed
First Posted : February 17, 2006
Last Update Posted : June 23, 2011
Sponsor:
Information provided by:
Central European Cooperative Oncology Group

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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Docetaxel Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2001
Actual Study Completion Date : September 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Docetaxel
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Docetaxel

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.

Drug: Docetaxel Drug: Docetaxel

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 Intervention: Comparative arm
No chemotherapy will be administered. No specific salvage therapy after progression is defined.



Primary Outcome Measures :
  1. 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 :
  1. to determine the impact on overall survival of adjuvant docetaxel and cisplatin.
  2. to characterise and quantitate toxicity related to this treatment regimen.
  3. to compare quality of life of patients on both treatment arms.


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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT00293085


Sponsors and Collaborators
Central European Cooperative Oncology Group
Investigators
Principal Investigator: Christoph C. Zielinski, Prof Univ. Klinik f. Innere Medizin I

Additional Information:
Responsible Party: Prof. Dr. Thomas Brodowicz, CECOG
ClinicalTrials.gov Identifier: NCT00293085     History of Changes
Other Study ID Numbers: CECOG/ NSCLC 2.2.001
First Posted: February 17, 2006    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: June 2011

Keywords provided by Central European Cooperative Oncology Group:
NSCLC
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
Cisplatin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action