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

National Cancer Center (NCC)

Status and phase: Unknown; Phase 2

Conditions: Lung Cancer

Treatments: Drug: chemotherapy; Radiation: Concurrent chemoradiation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00452803

NCCCTS-06-164

Details and patient eligibility

About

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.

Full 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

Enrollment: 102 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

study arm

Active Comparator group

Description:

pre-operative chemotherapy (Pac/Cis)

Treatment:

Drug: chemotherapy

study arm 2

Active Comparator group

Description:

Pre-operative concurrent chemoradiation therapy

Treatment:

Radiation: Concurrent chemoradiation therapy

Radiation: Concurrent chemoradiation therapy