Randomized Phase II Study of the Induction Chemotherapy With Docetaxel Alone vs CDDP + Docetaxel for c-Stage IB-II Non-Small Cell Lung Cancer (JCOG 0204-MF)


Phase 2
20 Years
74 Years
Not Enrolling
Both
Pulmonary Neoplasms

Thank you

Trial Information

Randomized Phase II Study of the Induction Chemotherapy With Docetaxel Alone vs CDDP + Docetaxel for c-Stage IB-II Non-Small Cell Lung Cancer (JCOG 0204-MF)


Preoperative chemotherapy has substantial theoretical advantage. Several controlled trials
are under way in early stage (clinical stage IB-II) nonsmall cell lung cancer (NSCLC). In
each trial, platinum-based doublet chemotherapy is employed. Although platinum-based doublet
is the treatment of choice for advanced NSCLC, risk/benefit balance might well be different
in earlier stages. There have been no prospective randomized trials to choose an optimal
preoperative chemotherapy in early stage NSCLC.

Comparison: Preoperative cisplatin-docetaxel combination versus docetaxel monotherapy in
clinical stage IB/II NSCLC.


Inclusion Criteria:



- Newly diagnosed, pathologically documented NSCLC

- Clinical stages IB (T2N0M0), IIA (T1N1M0) or IIB (T2N1M0 or T3N0M0)

- Ages: 15-74 years old

- ECOG performance status 0 or 1

- Measurable disease

- Ample organ function

- Signed informed consent

Exclusion Criteria:

- Invasion to the first rib or more superior chest wall

- Metastasis to, or involvement of, mediastinal node

- Active concomitant malignancy

- Unstable angina, recent myocardial infarction, or heart failure

- Uncontrolled diabetes or hypertension

- Pregnant or lactating women

- Other severe complications

- Systemic use of corticosteroids

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

disease-free survival rate at 1 year

Outcome Time Frame:

during the study conduct

Safety Issue:

No

Principal Investigator

Harubumi Kato, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Tokyo Medical University

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

JCOG 0204-MF

NCT ID:

NCT00132639

Start Date:

October 2002

Completion Date:

November 2008

Related Keywords:

  • Pulmonary Neoplasms
  • pulmonary neoplasm
  • preoperative chemotherapy
  • cisplatin, docetaxel
  • randomized trial
  • clinical stage IB or II nonsmall cell lung cancer
  • Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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