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

NCT00452803 | Unknown Phase 2

• 1 other identifier: NCCCTS-06-164
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

Non small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

study arm

ACTIVE COMPARATOR

pre-operative chemotherapy (Pac/Cis)

Drug: chemotherapy

study arm 2

ACTIVE COMPARATOR

Pre-operative concurrent chemoradiation therapy

Drug: Concurrent chemoradiation therapy; Radiation: Concurrent chemoradiation therapy

Interventions

chemotherapy DRUG

Paclitaxel 90mg/m2 + Cisplatin 40mg/m2 on D1 \& 8 q 3weeks, Pre-OP \& post-op : 2cycles (total 4 cycles)

study arm

Concurrent chemoradiation therapy DRUG

Paclitaxel 50mg/m2 + Cisplatin 20mg/m2 on D1 \& 8 q 3weeks, Pre-OP \& post-op : 2cycles (total 4 cycles)

study arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Medical fitness of patients adequate for radical NSCLC surgery.
• 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.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center, Korea

Goyang-si, Gyeonggi-do, 411-769, South Korea

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Heung Tae Kim, M.D.

  National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heung Tae Kim, M.D.

CONTACT

+82-31-920-1602; htkim@ncc.re.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: March 27, 2007
• First Posted: March 28, 2007
• Study Start: April 1, 2006
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2012
• Last Updated: July 12, 2010

Record last verified: 2010-07

Locations

KR (1)