An Open, Randomized, Multicentre, Phase II Pilot Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Non-Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Docetaxel
* Drug: Docetaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Docetaxel<br>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<br> <br> Drug: Docetaxel<br>* 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.<br>|
| No Intervention: Comparative arm<br>No chemotherapy will be administered. No specific salvage therapy after progression is defined. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, Docetaxel