Combination Chemotherapy and Computer-Planned Radiation Therapy in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Computer systems that allow doctors to create a 3-dimensional picture of the tumor to plan treatment may result in more effective radiation therapy. It is not yet known which chemotherapy and/or radiation therapy regimen is more effective in treating non-small cell lung cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of different combination chemotherapy regimens and 3-dimensional radiation therapy in treating patients who have unresectable stage III non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: carboplatin Drug: gemcitabine hydrochloride Drug: paclitaxel Radiation: radiation therapy |
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: | Induction/Concurrent Chemotherapy and Dose-Escalated Three Dimensional Thoracic Radiation for Patients With Stage III Non Small Cell Lung Cancer: A Randomized Phase II Study |
- Response [ Time Frame: 18 months post treatment ] [ Designated as safety issue: No ]Response is assessed as failure free survival
- Overall Survival [ Time Frame: 6 years post treatment ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]Toxicity will be assessed during treatment
| Enrollment: | 69 |
| Study Start Date: | March 2002 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Paclitaxel + Carboplatin
Paclitaxel and carboplatin induction (2 cycles)followed by chemotherapy with the addition of radiotherapy for 7 cycles
|
Drug: carboplatin
Arm A: AUC=6 IV over 30 min for 2 cycles then AUC=2 IV over 30 min q wk for 7 wks Arm B: AUC=5 IV over 30 min for 2 cycles
Drug: paclitaxel
225 mg/sq m IV over 3 hrs q 21 days for 2 cycles, then 45 mg/sq m IV over 1 hr q wk for 7 wks
Radiation: radiation therapy
3-D XRT 7400 cGy total after induction (during cycles 3-9)
|
|
Experimental: Gemcitabine + Carboplatin
Gemcitabine and carboplatin induction (2cycles) followed by chemotherapy with the addition of radiotherapy for 7 cycles
|
Drug: carboplatin
Arm A: AUC=6 IV over 30 min for 2 cycles then AUC=2 IV over 30 min q wk for 7 wks Arm B: AUC=5 IV over 30 min for 2 cycles
Drug: gemcitabine hydrochloride
1000 mg/sq m IV over 30 min days 1 & 8 repeat q 21 days for 2 cycles; then 35 mg/sq m IV over 30 min 2X wk for 7 wks
Radiation: radiation therapy
3-D XRT 7400 cGy total after induction (during cycles 3-9)
|
Detailed Description:
OBJECTIVES:
- Compare the overall response rate, failure-free survival, and survival of patients with inoperable stage IIIA or IIIB non-small cell lung cancer treated with paclitaxel and carboplatin with concurrent 3-dimensional conformal radiotherapy (3-D XRT) vs gemcitabine and carboplatin with concurrent 3-D XRT.
- Compare the toxicity of these regimens in these patients.
- Compare the pattern of failure (locoregional vs distant failure) in patients treated with these regimens.
- Determine the feasibility of delivering 3-D XRT to patients in this multicenter study.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses. Patients then receive paclitaxel IV over 1 hour followed by carboplatin IV over 30 minutes once weekly and 3-dimensional conformal radiotherapy (3-D XRT) once daily 5 days a week. Treatment repeats weekly for 7 courses.
- Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses. Patients then receive gemcitabine IV over 30 minutes twice weekly and 3-D XRT as in arm I. Treatment repeats weekly for 7 courses.
In both arms, treatment continues in the absence of disease progression.
Patients are followed every 2 months for 2 years, every 4 months for 2 years, and then annually for 2 years.
PROJECTED ACCRUAL: A total of 82 patients (41 per treatment arm) will be accrued for this study within 9 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Squamous cell carcinoma
- Adenocarcinoma, including bronchoalveolar cell carcinoma
- Large cell anaplastic carcinoma, including giant and clear cell carcinoma
- Inoperable stage IIIA or IIIB disease
No direct invasion of vertebral body
- Tumors adjacent to a vertebral body without bone invasion allowed if all gross disease can be encompassed in radiotherapy boost field
- Contralateral mediastinal disease (N3) allowed if all gross disease can be encompassed in radiotherapy boost field
- No scalene, supraclavicular, or contralateral hilar node involvement
Transudate, cytologically negative, non-bloody pleural effusion allowed if it can be encompassed in radiotherapy field
- No exudative, bloody, or cytologically malignant pleural effusion
- Evidence of pleural effusion by chest CT scan but not chest x-ray that is too small to tap allowed
At least 1 unidimensionally measurable lesion
- At least 20 mm by conventional techniques OR
- At least 10 mm by spiral CT scan
The following are not considered measurable disease:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
- Tumor lesions in a previously irradiated field
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Granulocyte count at least 1,500/mm3
- Platelet count at least 100,000/mm3
Hepatic:
- Bilirubin less than 1.5 mg/dL
- AST less than 2 times upper limit of normal
Renal:
- Creatinine clearance 20-130 mL/min for females
- Creatinine clearance 20-150 mL/min for males
Pulmonary:
- FEV1 at least 1.2 L
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other currently active malignancy (defined as completed prior therapy and considered to be at less than 30% risk of relapse) except non-melanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy for NSCLC
- No other concurrent chemotherapy
Endocrine therapy:
- No concurrent hormonal therapy except steroids for adrenal failure or septic shock, hormones for non-disease-related conditions (e.g., insulin for diabetes), or glucocorticosteroids as antiemetics
Radiotherapy:
- See Disease Characteristics
- No prior radiotherapy for NSCLC
Surgery:
- At least 2 weeks since prior exploratory thoracotomy
Contacts and Locations
Show 74 Study Locations| Study Chair: | Arthur William Blackstock, MD | Comprehensive Cancer Center of Wake Forest University |
More Information
Additional Information:
Publications:
| Responsible Party: | Monica M Bertagnolli, MD, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00033553 History of Changes |
| Other Study ID Numbers: | CDR0000069300, U10CA031946, CALGB-30105 |
| Study First Received: | April 9, 2002 |
| Last Updated: | April 1, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Cancer and Leukemia Group B:
|
squamous cell lung cancer large cell lung cancer stage IIIA non-small cell lung cancer |
stage IIIB non-small cell lung cancer adenocarcinoma of the lung bronchoalveolar cell lung cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Gemcitabine Carboplatin Paclitaxel Antimetabolites, Antineoplastic Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on June 17, 2013