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18 Years
90 Years
Open (Enrolling)
Carcinoma, Non-Small-Cell Lung, Chemotherapy

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Trial Information

Patients with clinical stage IIIA N2 non-small cell lung cancer (NSCLC) have a 5-year
survival rate of 10% to 15%, much worse than those of earlier stages of disease. The use of
pre-operative (neo-adjuvant) chemotherapy has been shown to be beneficial in several
studies.1 However, the precise chemotherapeutic regimen for neoadjuvant therapy remains an
open question.

The treatment response and toxicity of chemotherapy vary widely among and within
individuals, and races. Recently, molecular predictive markers may help to identify who may
benefit from individual therapy. Many evidence shows that the level of ERCC1 (an excision
nuclease within the nucleotide excision repair pathway) is important for the repair of
platinum-DNA adducts and the response to platinum-based chemotherapy.2-5 Not only by
measuring protein and mRNA expression, studies addressed on the polymorphism of ERCC1(118
C/T and C8092A) had demonstrated impact on survival of chemotherapy-treated NSCLC
patients6,7. XPD/ERCC2 (xeroderma pigmentosum group D/excision repair cross-complementing
group 2) 8, XRCC1 (X-ray repair cross-complementing group 1) and XRCC3 (X-ray repair
cross-complementing group 3) are another three proteins involving NER, serving as prognostic
factor of survival.9 BRCA1 is a protein participating in recombinant repair (RR) and is
stronge predictive marker of chemotherapy response. BRCA1 functions as a differential
modulator of survival with cisplatin and antimicrotubule drugs (paclitaxel, docetaxel and
vinorelbine). Low level of BRCA1 enhance cisplatin activity but lead to resistance to
paclitaxel, docetaxel and vinorelbine, whereas the opposite phenomenon is observed in the
presence of normal or high levels of BRCA1. In contract, BRCA1 levels do not influence the
effect of gemcitabine10. On the contrary, RRM1 (ribonucleotid reductase subunit M1) is
involved in gemcitabine metabolism and DNA repair after chemotherapy damage, and increased
RRM1 mRNA expression has been related to gemcitabine resistance in NSCLC11. All these DNA
repair genes participate the pathogenesis, mechanism of chemotherapeutic resistance and
outcome of lung cancer patients.

Previously, a joint study done by NTUH and VGH Taipei used gemcitabine and cisplatin as
induction chemotherapy to treat 52 patient with stage III NSCLC, 36 were operable and 18
were completely resected.12 From 2004 till now, a prospective study has been performed in
NTUH using docetaxel and cisplatin as neoadjuvant regimen to treat patients with stage IIIA
(N2) non-small cell lung cancer. Up to now, more than 40 patients were enrolled, all of them
have received tumor sampling before chemotherapy and more 90% received operation with their
tumor resected. The tissue specimens are valuable as all these patients had received
protocolized treatment, with filed detailed clinical information collected systematically.
All the peroperative biopsied and operatively resected tumor tissues are available in
paffin-embedded block, some in frozen tissue stock, we plan to study the DNA polymorphism,
protein and RNA expression of the above-mentioned DNA repair genes in these two series of

Inclusion Criteria:

- NSCLC patients with stage III in NTUH

- Recieved neoadjuvant chemotherapy and received operation

Exclusion Criteria:

- Patients who did not received chemotherapy or they did not receive operation.

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Change of the expression status of the DNA repair genes after chemotherapy in Taiwanese NSCLC patients

Outcome Time Frame:

before and after chemotherapy

Safety Issue:


Principal Investigator

Chao-Chi Ho, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Internal Medicine and Emergency Medicine, National Taiwan University Hospital


Taiwan: Department of Health

Study ID:




Start Date:

September 2007

Completion Date:

August 2010

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Chemotherapy
  • Gene Expression
  • Carcinoma, Non-Small-Cell Lung
  • Chemotherapy
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung