Adjuvant CCRT vs CT in Minimal N2 NSCLC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01066234
Recruitment Status : Unknown
Verified April 2016 by Keunchil Park, Samsung Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : February 10, 2010
Last Update Posted : April 20, 2016
Information provided by (Responsible Party):
Keunchil Park, Samsung Medical Center

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

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

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2009
Actual Primary Completion Date : March 2014
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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).

Primary Outcome Measures :
  1. Disease-free survival [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: 36 months ]
  2. Pattern of relapse [ Time Frame: 36 months ]
  3. Toxicity profile [ Time Frame: 36 months ]
  4. Quality of life (QOL) [ Time Frame: 36 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01066234

Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Principal Investigator: Keunchil Park, M.D., Ph.D Samsung Medical Center

Responsible Party: Keunchil Park, Principal investigator, Samsung Medical Center Identifier: NCT01066234     History of Changes
Other Study ID Numbers: 2009-04-004
First Posted: February 10, 2010    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: April 2016

Keywords provided by Keunchil Park, Samsung Medical Center:
Microscopic N2 Non-small Cell Lung Cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action