Pre-operative Chemotherapy Versus Concurrent Chemoradiotherapy in N2 Positive IIIA Non Small Cell Lung Cancer (NSCLC)

Phase 2

• Conditions: Lung Cancer
• Interventions: Drug: chemotherapy; Radiation: Concurrent chemoradiation therapy

• Registration Number: NCT00452803
• Lead Sponsor: National Cancer Center, Korea

Brief 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.

Detailed Description

Preoperative Therapy Arm 1. (preoperative chemotherapy) Paclitaxel (90 mg/m2)on day 1 and 8 Cisplatin (40 mg/m2)on day 1 and 8. q 3 weeks, 2 cycles

Arm 2. (preoperative chemoradiotherapy) Paclitaxel (50 mg/m2)on day 1, 8, 15, 22 \& 29 Cisplatin (20 mg/m2)on day 1, 8, 15, 22 \& 29. Thoracic radiation therapy (TRT) 1.8 Gy daily, five times per week (45 Gy target dose in 5 weeks).

Postoperative Consolidation Chemotherapy:

Paclitaxel (90 mg/m2) on day 1 and 8. Cisplatin (40 mg/m2) on day 1 and 8. q 3weeks, 2 cycles

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2007-03-27
• Study First Submitted QC: 2007-03-27
• Study First Posted: 2007-03-28
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-09
• Last Update Posted: 2010-07-12
• Primary Completion: 2011-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

1. Histologic or cytologic diagnosis of non-small cell lung cancer.
2. 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.
3. Tumor amenable to surgical resection.
4. At least one unidimensional measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST. 2000).
5. No prior tumor therapy (surgery, radiotherapy, chemotherapy, immunotherapy, or any other type of tumor therapy).
6. Performance status of 0-1 on ECOG scale.
7. At least 18 years old.
8. Patient compliance that allows adequate follow-up.
9. Medical fitness of patients adequate for radical NSCLC surgery.
10. Adequate organ function including the following:Adequate hematologic function: WBC count ≥ 4,000/uL, absolute neutrophil count (ANC) ≥ 1,500/uL, platelet count ≥ 100,000/uL, and hemoglobin ≥ 10 gm/dL.Adequate hepatic function: bilirubin ≤ 1.5 x UNL, ALT or AST ≤ 2.5 x UNL.Adequate renal function: creatinine ≤ 1.5mg/dL.
11. Signed informed consent from patient or legal representative.12. Patients with reproductive potential must use an approved contraceptive method during and for 3 months after the study. Females with childbearing potential must have a negative urine hCG test within 7 days prior to study enrollment.

Exclusion Criteria

1. Concurrent administration of any other tumor therapy, including radiotherapy, chemotherapy, immunotherapy.
2. Active uncontrolled infection.
3. Serious concomitant disorders that would compromise the safety of patient or compromise the patient's ability to tolerate therapy.
4. MI within preceding 6 months or symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmia.
5. Significant neurological or mental disorder.
6. Second primary malignancy.
7. Pregnant or nursing.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study arm	chemotherapy	pre-operative chemotherapy (Pac/Cis)
study arm 2	Concurrent chemoradiation therapy	Pre-operative concurrent chemoradiation therapy

Primary Outcome Measures

Name	Time	Method
To estimate the time to recurrence	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

Secondary Outcome Measures

Name	Time	Method
To estimate the overall survival	from the date of randomization to the date of death
To assess the pathologic complete response rate and the complete resection rate	After surgery
To estimate toxicities	from the first date of treatment to 30 days after the last dose of study drug

Trial Locations

Locations (1)

National Cancer Center, Korea; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of