An Open, Randomized, Multicentre, Phase II Pilot Study

NCT00293085 | Completed Phase 2

• 1 other identifier: CECOG/ NSCLC 2.2.001
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-Small Cell Lung Cancer

Keywords

NSCLC; Docetaxel

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

Study Arms (2)

Docetaxel

ACTIVE COMPARATOR

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

Comparative arm

NO INTERVENTION

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

Interventions

Docetaxel DRUG

Docetaxel

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Central European Cooperative Oncology Group: lead

Related Links

• Related Info

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Christoph C. Zielinski, Prof

  Univ. Klinik f. Innere Medizin I

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 16, 2006
• First Posted: February 17, 2006
• Study Start: December 1, 2001
• Study Completion: September 1, 2003
• Last Updated: June 23, 2011

Record last verified: 2011-06