An Open, Randomized, Multicentre, Phase II Pilot Study

Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00293085
• Other study ID #: CECOG/ NSCLC 2.2.001
• Status: Completed
• Phase: Phase 2
• First received: February 16, 2006
• Last updated: June 22, 2011
• Start date: December 2001
• Est. completion date: September 2003

Study information

• Verified date: June 2011
• Source: Central European Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and WomenHungary: National Institute of Pharmacy
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Docetaxel

• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central European Cooperative Oncology Group

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	to determine the impact on overall survival of adjuvant docetaxel and cisplatin.
Secondary	to characterise and quantitate toxicity related to this treatment regimen.
Secondary	to compare quality of life of patients on both treatment arms.

External Links

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