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

Primary Purpose

Lung Cancer

Status

Unknown status

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

chemotherapy

Concurrent chemoradiation therapy

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Non small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.
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.

Exclusion Criteria:

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.

Sites / Locations

National Cancer Center, KoreaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

study arm

study arm 2

Arm Description

pre-operative chemotherapy (Pac/Cis)

Pre-operative concurrent chemoradiation therapy

Outcomes

Primary Outcome Measures

To estimate the time to recurrence

Secondary Outcome Measures

To estimate the overall survival

To assess the pathologic complete response rate and the complete resection rate

To estimate toxicities

Full Information

NCT ID

NCT00452803

First Posted

March 27, 2007

Last Updated

July 9, 2010

Sponsor

National Cancer Center, Korea

1. Study Identification

Unique Protocol Identification Number

NCT00452803

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2010

Overall Recruitment Status

Unknown status

Study Start Date

April 2006 (undefined)

Primary Completion Date

December 2011 (Anticipated)

Study Completion Date

December 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

National Cancer Center, Korea

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

Keywords

Non small cell lung cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

study arm

Arm Type

Active Comparator

Arm Description

pre-operative chemotherapy (Pac/Cis)

Arm Title

study arm 2

Arm Type

Active Comparator

Arm Description

Pre-operative concurrent chemoradiation therapy

Intervention Type

Drug

Intervention Name(s)

chemotherapy

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Concurrent chemoradiation therapy

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

Concurrent chemoradiation therapy

Intervention Description

Preoperative Thoracic radiation: 180cGy/fx, total: 4500cGy, 25fx

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

To estimate the overall survival

Time Frame

from the date of randomization to the date of death

Title

To assess the pathologic complete response rate and the complete resection rate

Time Frame

After surgery

Title

To estimate toxicities

Time Frame

from the first date of treatment to 30 days after the last dose of study drug

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Heung Tae Kim, M.D.

Phone

+82-31-920-1602

htkim@ncc.re.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Heung Tae Kim, M.D.

Organizational Affiliation

National Cancer Center, Korea

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Cancer Center, Korea

City

Goyang-si

State/Province

Gyeonggi-do

ZIP/Postal Code

411-769

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jae-Ill Zoo, M.D.

First Name & Middle Initial & Last Name & Degree

Jong Mog Lee, M.D.

First Name & Middle Initial & Last Name & Degree

Moon Soo Kim, M.D.

First Name & Middle Initial & Last Name & Degree

Hyun-Sung Lee, M.D.

First Name & Middle Initial & Last Name & Degree

Jin Soo Lee, M.D.

First Name & Middle Initial & Last Name & Degree

Ji-Youn Han, M.D.

First Name & Middle Initial & Last Name & Degree

Kwan Ho Cho, M.D.

First Name & Middle Initial & Last Name & Degree

Hong Ryull Pyo, M.D.

First Name & Middle Initial & Last Name & Degree

Bin Hwangbo, M.D.

First Name & Middle Initial & Last Name & Degree

Hee Seok Lee, M.D.

First Name & Middle Initial & Last Name & Degree

Hyae Young Kim, M.D.

First Name & Middle Initial & Last Name & Degree

Geon Kook Lee, M.D.

First Name & Middle Initial & Last Name & Degree

Moon Woo Seong, M.D.

First Name & Middle Initial & Last Name & Degree

Kyeong-Man Hong, M.D.

First Name & Middle Initial & Last Name & Degree

Byung-Ho Nam, Ph.D.

First Name & Middle Initial & Last Name & Degree

Tak Yun, M.D.

12. IPD Sharing Statement

Learn more about this trial

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

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