An Open, Randomized, Multicentre, Phase II Pilot Study

Central European Cooperative Oncology Group

Status and phase: Completed; Phase 2

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: Docetaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT00293085

CECOG/ NSCLC 2.2.001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 2 patient groups

Docetaxel

Active Comparator group

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.

Treatment:

Drug: Docetaxel

Drug: Docetaxel

Comparative arm

No Intervention group

Description:

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