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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00452803
• Other study ID #: NCCCTS-06-164
• Status: Recruiting
• Phase: Phase 2
• First received: March 27, 2007
• Last updated: July 9, 2010
• Start date: April 2006
• Est. completion date: December 2012

Study information

• Verified date: July 2010
• Source: National Cancer Center, Korea
• Contact: Heung Tae Kim, M.D.
• Phone: +82-31-920-1602
• Email: htkim[@]ncc.re.kr
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center, Korea	Goyang-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To estimate the overall survival		from the date of randomization to the date of death	No
Secondary	To assess the pathologic complete response rate and the complete resection rate		After surgery	No
Secondary	To estimate toxicities		from the first date of treatment to 30 days after the last dose of study drug	Yes