Know Cancer

forgot password

Multimodality Therapy for Stages II and III Non-Small Cell Lung Cancer: Surgical Resection Followed by Sequential Administration of Gemcitabine Plus Cisplatin Chemotherapy and Radiation Therapy

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

Multimodality Therapy for Stages II and III Non-Small Cell Lung Cancer: Surgical Resection Followed by Sequential Administration of Gemcitabine Plus Cisplatin Chemotherapy and Radiation Therapy


- To assess overall survival and progression-free survival of patients with stage II-IIIB
non-small cell lung cancer undergoing surgical resection, followed by adjuvant
chemotherapy comprising gemcitabine and cisplatin, and radiotherapy.

- To assess the toxicities of this regimen in these patients.

- To evaluate the mRNA expression of enzymes (i.e., excision repair cross complementing
protein, ribonucleotide reductase, and cytidine/deoxycytidine deaminase and kinase),
which may be important in regulating the cytotoxicity of gemcitabine and cisplatin in
patient tumors.

- To correlate mRNA levels with progression-free survival of patients treated with this

- To assess BCL2, P53, and HER2-neu expression by IHC and correlation with
progression-free survival.

OUTLINE: Patients undergo surgical resection of their tumor and mediastinal lymph node
dissection. Patients with complete surgical eradication of their disease or pathologic
evidence of microscopic residual disease proceed to adjuvant chemotherapy.

Within approximately 60 days after surgical resection, patients receive adjuvant
chemotherapy comprising gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over
1 hour on day 8. Treatment repeats every 21 days for up to 3 courses in the absence of
disease progression or unacceptable toxicity.

Beginning 130-144 days after surgery, patients undergo radiotherapy once daily, five days a
week, for approximately 6 weeks.

Tumor tissue specimens are obtained at the time of surgical resection for pharmacodynamic
and biomarker correlative studies. Specimens are examined by reverse
transcriptase-polymerase chain reaction to measure mRNA expression of target oncogenes
(i.e., DNA repair gene ERCC-1 and M2 subunit of the DNA repair gene ribonucleotide
reductase) and enzymes (i.e., cytidine/deoxycytidine deaminase and kinase). Resected
specimens are also assessed by IHC for the expression of BCL2, P53, and HER2-neu genes.

After completion of study therapy, patients are followed every 6 months for 5 years and
annually thereafter.

Inclusion Criteria


- Histologically or cytologically confirmed single, primary bronchogenic non-small cell
lung cancer meeting the following subtypes:

- Adenocarcinoma (no bronchioalveolar cell histology)

- Squamous cell carcinoma

- Large cell carcinoma

- Meeting the following staging criteria:

- Stage IIB (T2, N1, M0, or T3, N0, M0)

- Stage IIIA (T1-3, N2, M0 or T3, N1, M0)

- Stage IIIB (Any T, N3, M0 or T4, Any N, M0)

- No more than 1 parenchymal lesion in the same lung or in both lungs

- No tumor involving the superior sulcus (e.g., Pancoast tumor)

- Patients must undergo evaluation by the involved thoracic surgeon, medical
oncologist, and radiation oncologist prior to registration

- No evidence of metastatic disease

- Biopsy or aspiration cytology required to confirm the benign diagnosis of CT or
MRI abnormalities that potentially represent metastatic disease

- Biopsy required if all noninvasive tests are indeterminant


- Karnofsky performance status 70-100%

- Absolute granulocyte count ≥ 1,500/μL

- Platelet count ≥ 100,000/μL

- Bilirubin ≤ 3 times upper limit of normal (ULN)

- SGOT and SGPT ≤ 3 times ULN

- Creatinine clearance > 50 mL/min

- No prior malignancy except adequately treated basal cell or squamous cell skin
cancer, carcinoma in situ of the cervix, ductal or lobular carcinoma in situ of the
breast, or any other cancer from which the patient has been disease-free for 5 years

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective protection

- No significant hearing loss or patient unwilling to accept potential for further
hearing loss

- No uncontrolled medical illness by appropriate medical therapy (e.g., myocardial
infarction within the past 3 months or liver cirrhosis)

- No symptomatic peripheral neuropathy affecting activities of daily living


- No prior chemotherapy or radiotherapy for lung cancer

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Relapse-free survival from the date of surgery

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Marianna Koczywas, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Research Institute


United States: Federal Government

Study ID:




Start Date:

August 1999

Completion Date:

June 2013

Related Keywords:

  • Lung Cancer
  • stage II non-small cell lung cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms