An Open, Randomized, Multicentre, Phase II Pilot Study

NCT ID: NCT00293085

Last Updated: 2011-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-12-31
• Study Completion Date: 2003-09-30

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.

Conditions

Non-Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Docetaxel

Intervention Type: DRUG

Docetaxel

Intervention Type: DRUG

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.

Comparative arm

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Docetaxel

Intervention Type: 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central European Cooperative Oncology Group

OTHER

Sponsor Role: lead

Responsible Party

CECOG

Principal Investigators

Christoph C. Zielinski, Prof

Role: PRINCIPAL_INVESTIGATOR

Univ. Klinik f. Innere Medizin I

Related Links

http://www.cecog.org

Related Info

Other Identifiers

CECOG/ NSCLC 2.2.001

Identifier Type: -

Identifier Source: org_study_id