Adjuvant CCRT vs CT in Minimal N2 NSCLC

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Keunchil Park, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01066234
First received: February 8, 2010
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

This study propose adjuvant concurrent chemoradiotherapy vs chemotherapy alone in completely resected microscopic N2 NSCLC


Condition Intervention Phase
Non-small Cell Lung Cancer
Radiation: concurrent chemoradiotherapy
Drug: chemotherapy only
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Adjuvant Concurrent Chemoradiotherapy vs Chemotherapy Alone in Completely Resected Microscopic N2 Non-small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Disease-free survival [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall survival (OS) [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Pattern of relapse [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Toxicity profile [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Quality of life (QOL) [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: April 2009
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: concurrent chemoradiotherapy Radiation: concurrent chemoradiotherapy
weekly paclitaxel 50mg/m2 plus weekly cisplatin 25mg/m2 5times with concurrent radiotherapy (5000rad/25fx) for 5 weeks followed by 2 cycles of 3-weekly paclitaxel (175mg/m2) plus cisplatin 80mg/m2.
Active Comparator: chemotherapy only Drug: chemotherapy only
four cycles of 3-weekly paclitaxel (175mg/m2) and carboplatin (AUC5.5).

Detailed Description:

Approximately 15% of patients with non-small cell lung cancer are diagnosed with stage IIIA-N2 disease. However, this subgroup is heterogeneous, with lymph nodes that are only microscopically invaded to those that are radiologically visible with bulky ipsilateral mediastinal lymph node involvement. Surgical resection in selected patients results in 5-year survival rates of 7-24%.

The standard treatment for locally advanced clinical N2 disease is definitive concurrent chemoradiotherapy or induction chemotherapy (± radiation) followed by operation. However, in some patients, N2 status could be confirmed only after curative operation without any evidence of N2 diseases through preoperative evaluation methods (CT, PET, mediastinoscopy). We usually define those N2 disease found only after curative operation as microscopic N2, and do adjuvant chemotherapy, radiotherapy or concurrent chemoradiotherapy. However, little data about the adjuvant therapy for completely resected N2 disease have been available, Hence, we propose a randomized phase II study of adjuvant concurrent chemoradiotherapy vs chemotherapy alone in completely resected microscopic N2 NSCLC.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed diagnosis of stage IIIA(N2) NSCLC that was completely resected by lobectomy, bilobectomy, pneumonectomy, or sleeve lobectomy through any incision (thoracoscopic or video-assisted thorascopic surgery approaches were acceptable)
  2. "Pathologic N2" disease (involvement of N2 nodes can only be determined at the time of surgical exploration or postoperative pathologic analysis)
  3. Age ≥18years
  4. No known residual disease (negative resection margin and no extracapsular invasion of lymph node metastasis)
  5. ECOG performance status of 0 to 1
  6. No previous chemotherapy or RT
  7. Adequate organ function as evidenced by the following; Absolute neutrophil count > 1.5 x 109/L; platelets > 100 x 109/L; total bilirubin ≤1.5 UNL; AST and/or ALT < 5 UNL; creatinine clearance ≥ 50mL/min
  8. Written informed consent form

Exclusion Criteria:

  1. Patients with preoperative mediastinoscopic N2 positive disease
  2. Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia
  3. Patients with post-obstructive pneumonia or uncontrolled serious infection
  4. Pregnant or nursing women ( Women of reproductive potential have to agree to use an effective contraceptive method)
  5. Prior history of malignancy within 5 years from study entry except for a adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01066234

Contacts
Contact: Keunchil Park, M.D., Ph.D 822-3410-3450 kpark@skku.edu

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Keunchil Park, M.D., Ph.D.    822-3410-3450    kpark@skku.edu   
Principal Investigator: Keunchil Park, M.D., Ph.D.         
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Keunchil Park, M.D., Ph.D Samsung Medical Center
  More Information

No publications provided

Responsible Party: Keunchil Park, Principal investigator, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01066234     History of Changes
Other Study ID Numbers: 2009-04-004
Study First Received: February 8, 2010
Last Updated: May 29, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Samsung Medical Center:
Microscopic N2 Non-small Cell Lung Cancer
Paclitaxel
Carboplatin
Cisplatin

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 21, 2014