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Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

Primary Purpose

Lung Cancer

Status

Unknown status

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

cisplatin

etoposide

irinotecan hydrochloride

radiation therapy

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Stage IIIA (N2) or IIIB disease
  - Pathologic documentation of N2-3 mediastinal lymph nodes is encouraged but not required if nodal size is ≥ 1.5 cm in largest diameter
  - No stage IIIB disease with malignant pleural effusion or superior sulcus tumor
At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors
Unresectable disease
No known brain metastasis

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Life expectancy > 3 months
ANC ≥ 1,500/mm³
Hemoglobin ≥ 9.0 g/dL (can be corrected by transfusion)
Platelet count ≥ 100,000/mm³
Creatinine < 1.5 mg/dL
Total bilirubin < 2 times upper limit of normal (ULN)
Transaminases < 3 times ULN
Patient compliance and geographic proximity that allow adequate follow up
No serious, uncontrolled systemic intercurrent illness (e.g., infections or poorly controlled diabetes)
No history of significant neurological or mental disorder, including seizures or dementia
No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer
No active cardiac disease not controlled by therapy
No myocardial infarction within the past 12 months

PRIOR CONCURRENT THERAPY:

No prior chemotherapy or radiotherapy for NSCLC
No other concurrent systemic chemotherapy, investigational drug, or radiotherapy

Sites / Locations

Yonsei Cancer Center at Yonsei University Medical CenterRecruiting

Outcomes

Primary Outcome Measures

Rate of local/regional control

Rate of systemic disease control

Feasibility of radiotherapy administered concurrently with etoposide and cisplatin chemotherapy

Secondary Outcome Measures

Toxicity of irinotecan hydrochloride and cisplatin induction chemotherapy as assessed by NCI CTCAE v3.0

Progression-free survival

Overall survival

Full Information

NCT ID

NCT00616785

First Posted

February 14, 2008

Last Updated

February 6, 2009

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT00616785

Brief Title

Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

Official Title

Phase II Trial Irinotecan and Cisplatin Induction Chemotherapy Followed by Radiotherapy Concurrently With Etoposide/Cisplatin in Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

September 2008

Overall Recruitment Status

Unknown status

Study Start Date

June 2007 (undefined)

Primary Completion Date

November 2010 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Yonsei University

4. Oversight

5. Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan, cisplatin, and etoposide work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.

Detailed Description

OBJECTIVES: Primary To evaluate the efficacy of induction chemotherapy comprising irinotecan hydrochloride and cisplatin in patients with locally advanced, unresectable stage III non-small cell lung cancer. To evaluate the feasibility of radiotherapy administered concurrently with etoposide and cisplatin chemotherapy after induction chemotherapy in these patients. Secondary To evaluate the toxicity of induction chemotherapy comprising irinotecan hydrochloride and cisplatin in these patients. To assess whether this induction chemotherapy regimen will improve patient survival when compared with outcomes from the predecessor study, SWOG-9019. OUTLINE: Patients receive dose-dense induction chemotherapy comprising irinotecan hydrochloride IV and cisplatin IV on days 1 and 8. Treatment repeats every 21 days for up to 2 courses. After completion of induction chemotherapy, patients undergo radiotherapy five days a week for approximately 7 weeks. Patients receive concurrent chemotherapy comprising cisplatin IV on days 1, 8, 29, and 36 and etoposide IV on days 1-5 and 29-33. After completion of study therapy, patients are followed at 6 weeks.

6. Conditions and Keywords

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

Lung Cancer

Keywords

stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Masking

None (Open Label)

Enrollment

41 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

cisplatin

Intervention Type

Drug

Intervention Name(s)

etoposide

Intervention Type

Drug

Intervention Name(s)

irinotecan hydrochloride

Intervention Type

Radiation

Intervention Name(s)

radiation therapy

Primary Outcome Measure Information:

Title

Rate of local/regional control

Title

Rate of systemic disease control

Title

Feasibility of radiotherapy administered concurrently with etoposide and cisplatin chemotherapy

Secondary Outcome Measure Information:

Title

Toxicity of irinotecan hydrochloride and cisplatin induction chemotherapy as assessed by NCI CTCAE v3.0

Title

Progression-free survival

Title

Overall survival

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) Stage IIIA (N2) or IIIB disease Pathologic documentation of N2-3 mediastinal lymph nodes is encouraged but not required if nodal size is ≥ 1.5 cm in largest diameter No stage IIIB disease with malignant pleural effusion or superior sulcus tumor At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors Unresectable disease No known brain metastasis PATIENT CHARACTERISTICS: ECOG performance status 0-2 Life expectancy > 3 months ANC ≥ 1,500/mm³ Hemoglobin ≥ 9.0 g/dL (can be corrected by transfusion) Platelet count ≥ 100,000/mm³ Creatinine < 1.5 mg/dL Total bilirubin < 2 times upper limit of normal (ULN) Transaminases < 3 times ULN Patient compliance and geographic proximity that allow adequate follow up No serious, uncontrolled systemic intercurrent illness (e.g., infections or poorly controlled diabetes) No history of significant neurological or mental disorder, including seizures or dementia No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer No active cardiac disease not controlled by therapy No myocardial infarction within the past 12 months PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy for NSCLC No other concurrent systemic chemotherapy, investigational drug, or radiotherapy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joo-Hang Kim, MD

Organizational Affiliation

Yonsei University

Official's Role

Study Chair

Facility Information:

Facility Name

Yonsei Cancer Center at Yonsei University Medical Center

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joo-Hang Kim, MD

Phone

+82-10-4507-6063

kjhang@yuhs.ac

12. IPD Sharing Statement

Learn more about this trial

Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

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