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

July 9, 2010 updated by: National Cancer Center, Korea

A Randomized Phase II Study Preoperative Chemotherapy Versus Preoperative Concurrent Chemoradiotherapy for Patients With Biopsy-Proven N2 Stage IIIA Non-Small Cell Lung Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

102

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Heung Tae Kim, M.D.
  • Phone Number: +82-31-920-1602
  • Email: htkim@ncc.re.kr

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 411-769
        • Recruiting
        • National Cancer Center, Korea
        • Sub-Investigator:
          • Jae-Ill Zoo, M.D.
        • Sub-Investigator:
          • Jong Mog Lee, M.D.
        • Sub-Investigator:
          • Moon Soo Kim, M.D.
        • Sub-Investigator:
          • Hyun-Sung Lee, M.D.
        • Sub-Investigator:
          • Jin Soo Lee, M.D.
        • Sub-Investigator:
          • Hyae Young Kim, M.D.
        • Sub-Investigator:
          • Moon Woo Seong, M.D.
        • Sub-Investigator:
          • Kyeong-Man Hong, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: study arm
pre-operative chemotherapy (Pac/Cis)
Drug: chemotherapy
Paclitaxel 90mg/m2 + Cisplatin 40mg/m2 on D1 & 8 q 3weeks, Pre-OP & post-op : 2cycles (total 4 cycles)
Active Comparator: study arm 2
Pre-operative concurrent chemoradiation therapy
Drug: Concurrent chemoradiation therapy
Paclitaxel 50mg/m2 + Cisplatin 20mg/m2 on D1 & 8 q 3weeks, Pre-OP & post-op : 2cycles (total 4 cycles)
Radiation: Concurrent chemoradiation therapy
Preoperative Thoracic radiation: 180cGy/fx, total: 4500cGy, 25fx

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To estimate the time to recurrence
Time Frame: 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
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Investigators

  • Principal Investigator: Heung Tae Kim, M.D., National Cancer Center, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

March 27, 2007

First Submitted That Met QC Criteria

March 27, 2007

First Posted (Estimate)

March 28, 2007

Study Record Updates

Last Update Posted (Estimate)

July 12, 2010

Last Update Submitted That Met QC Criteria

July 9, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCCTS-06-164

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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