An Open, Randomized, Multicentre, Phase II Pilot Study

This study has been completed.
Sponsor:
Information provided by:
Central European Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00293085
First received: February 16, 2006
Last updated: June 22, 2011
Last verified: June 2011
  Purpose

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 Intervention Phase
Non-Small Cell Lung Cancer
Drug: Docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Central European Cooperative Oncology Group:

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.

Enrollment: 37
Study Start Date: December 2001
Study Completion Date: September 2003
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00293085

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

Additional Information:
No publications provided

Responsible Party: Prof. Dr. Thomas Brodowicz, CECOG
ClinicalTrials.gov Identifier: NCT00293085     History of Changes
Other Study ID Numbers: CECOG/ NSCLC 2.2.001
Study First Received: February 16, 2006
Last Updated: June 22, 2011
Health Authority: Austria: Federal Ministry for Health and Women
Hungary: National Institute of Pharmacy

Keywords provided by Central European Cooperative Oncology Group:
NSCLC
Docetaxel

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Cisplatin
Serotonin 5-HT3 Receptor Antagonists
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 19, 2014