Pre-operative Chemotherapy Versus Concurrent Chemoradiotherapy in N2 Positive IIIA Non Small Cell… (NCT00452803) | Clinical Trial Compass
UnknownPhase 2
Pre-operative Chemotherapy Versus Concurrent Chemoradiotherapy in N2 Positive IIIA Non Small Cell Lung Cancer (NSCLC)
South Korea102 participantsStarted 2006-04
Plain-language summary
It is suggested that a bimodal or trimodal approach combining neoadjuvant chemotherapy with or without radiotherapy followed by surgery provides a potentially superior method of enhancing resectability and improving locoregional control and survival compared to radiotherapy alone followed by surgery. Unsolved questions are the identification of the best induction strategy, the impact of surgery on long-term survival, and the contribution of radiation therapy in this setting. Thus, the investigators conduct a phase II trial to compare neoadjuvant chemotherapy with concurrent chemoradiotherapy in patients with biopsy proven N2 stage IIIA NSCLC to address optimal induction strategy.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histologic or cytologic diagnosis of non-small cell lung cancer.
✓. Presence of biopsy-proven N2 stage IIIA, according to the American Joint Committee on Cancer (AJCC), with none of the mediastinal lymph nodes \> 3 cm in largest diameter.
✓. Tumor amenable to surgical resection.
✓. At least one unidimensional measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST. 2000).
✓. No prior tumor therapy (surgery, radiotherapy, chemotherapy, immunotherapy, or any other type of tumor therapy).
✓. Performance status of 0-1 on ECOG scale.
✓. At least 18 years old.
✓. Patient compliance that allows adequate follow-up.
Exclusion criteria
✕. Concurrent administration of any other tumor therapy, including radiotherapy, chemotherapy, immunotherapy.
What they're measuring
1
To estimate the time to recurrence
Timeframe: The interval from the date of randomization to the date to the date of the first objective evidence of recurrence or to the date of death, if before recurrence