| Chemoradiotherapy Followed By Surgery and Docetaxel in Treating Patients With Pancoast Tumors |
| A Phase II Trial of Induction Chemoradiotherapy With Cisplatin/Etoposide Followed by Surgical Resection, Followed by Docetaxel, for Non-Small Cell Lung Cancer Involving the Superior Sulcus (Pancoast Tumors) |
RATIONALE: Drugs used in chemotherapy, such as cisplatin, etoposide, and docetaxel, 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. Combining cisplatin and etoposide with radiation therapy may shrink the tumor so it can be removed by surgery. Giving docetaxel after surgery may kill any remaining tumor cells.
PURPOSE: This phase II trial is studying how well giving chemoradiotherapy together with cisplatin and etoposide followed by surgery and docetaxel works in treating patients with newly diagnosed Pancoast tumors, a type of non-small cell lung cancer. |
OBJECTIVES:
- Determine the feasbility of administering induction chemoradiotherapy comprising cisplatin and etoposide followed by surgical resection and adjuvant docetaxel in patients with non-small cell lung cancer involving the superior sulcus (Pancoast tumors).
- Determine overall survival of patients treated with this regimen.
- Determine time to progression in patients treated with this regimen.
- Determine confirmed and unconfirmed and complete and partial response during induction in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE:
- Induction chemoradiotherapy: Patients receive etoposide IV over 1 hour on days 1-5 and 29-33 and cisplatin IV over 1 hour on days 1, 8, 29, and 36. Patients also undergo concurrent radiotherapy once daily 5 days a week for 5 weeks.
Within 2-4 weeks after completion of induction chemoradiotherapy, patients undergo disease evaluation. Patients with no evidence of local or overall disease progression undergo a thoracotomy within 3-7 weeks. Patients who do not qualify for surgery proceed to consolidation chemotherapy within 3-8 weeks after chemoradiotherapy is complete.
- Consolidation chemotherapy: Within 3-8 weeks after thoracotomy, patients with no evidence of disease progression receive docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4-6 weeks, every 3 months for 2 years, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study. |
| Phase II |
| Interventional |
| Treatment, Open Label |
Measurability of lesions [ Designated as safety issue: No ]
Objective status [ Designated as safety issue: No ]
Response [ Designated as safety issue: No ]
Performance status [ Designated as safety issue: No ]
Progression-free survival [ Designated as safety issue: No ]
Time to death [ Designated as safety issue: No ] |
|
| Lung Cancer |
Drug: cisplatin
Drug: docetaxel
Drug: etoposide
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Procedure: radiation therapy |
|
Clinical trial summary from the National Cancer Institute's PDQ® database  |
|
| Active, not recruiting |
| 45 |
| July 2003 |
|
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer
Must meet 1 of the following tumor involvement criteria:
- An apical tumor associated with the Pancoast syndrome (arm or shoulder pain and/or neurologic findings corresponding to the roots of C-8 and/or T-1 or the inferior trunk of the bronchial plexus with or without Horner's syndrome) without rib or vertebral body involvement
- Superior sulcus tumors with involvement of the chest wall (T3), usually ribs 1 and 2 by CT scan or MRI, with or without an associated Pancoast syndrome
- Superior sulcus tumors with invasion of the vertebral bodies or involvement of the subclavian vessels (T4) by CT scan or MRI, with or without an associated Pancoast syndrome
- No more than 1 parenchymal lesion in the same lung or in both lungs
No involvement of the following lymph node groups as determined by mediastinal exploration* (i.e., mediastinoscopy, mediastinotomy, thoracoscopy, or thoracotomy) within the past 42 days:
No pleural effusions except if 1 of the following criteria are met:
- Pleural effusion present before mediastinoscopy or thoracotomy with negative cytology on 2 separate thoracenteses
- Pleural effusion present only after exploratory or staging thoracotomy, with negative cytology on a single thoracentesis
- Present only on CT scan and too small to tap
- No pericardial effusions or superior vena cava syndrome
- No brain metastases by CT scan or MRI
- No evidence of distant metastatic disease by bone scan or PET
- Must be a candidate for potential future pulmonary resection
PATIENT CHARACTERISTICS:
Age
Performance status
Zubrod 0-2
- Patients with Zubrod performance status 2 must have an albumin level at least 0.85 times lower limit of normal and weight loss no greater than 10%
Life expectancy
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)*
- SGOT or SGPT no greater than 1.5 times ULN* NOTE: *Unless due to a documented benign disease
Renal
- Creatinine clearance at least 50 mL/min
Cardiovascular
- No myocardial infarction within the past 3 months
- No active angina
- No unstable heart rhythms
- No clinically evident congestive heart failure
Pulmonary
- Preresection FEV_1 at least 2.0 L OR
- Predicted postresection FEV_1 greater than 1.0 L
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No uncontrolled peptic ulcer disease
- No grade 2 or greater sensory neuropathy
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent colony-stimulating factors during chemoradiotherapy or course 1 of consolidation therapy
Chemotherapy
- No prior chemotherapy for lung cancer
Endocrine therapy
Radiotherapy
- No prior radiotherapy to the neck or thorax
- No concurrent intensity-modulated radiotherapy
Surgery
- Prior exploratory thoracotomy allowed only for diagnosis or staging purposes
Other
|
| Both |
|
| No |
|
| United States |
|
| NCT00062439 |
| CDR0000304777 |
| SWOG-S0220, ECOG-S0220, ACOSOG-SWOG-S0220, NCCTG-SWOG-S0220, CAN-NCIC-SWOG-S0220, CALGB-30501 |
| Southwest Oncology Group |
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
American College of Surgeons
North Central Cancer Treatment Group
National Cancer Institute of Canada
Cancer and Leukemia Group B |
| Study Chair: |
Michael J. Kraut, MD |
Providence Cancer Institute at Providence Hospital - Southfield Campus |
|
| Study Chair: |
Tien Hoang, MD |
University of Wisconsin, Madison |
|
| Study Chair: |
Valerie W. Rusch, MD, FACS |
Memorial Sloan-Kettering Cancer Center |
|
| Study Chair: |
James R. Jett, MD |
Mayo Clinic |
|
| Study Chair: |
Scott A. Laurie, MD, FRCPC |
Ottawa Hospital Regional Cancer Centre - General Campus |
|
| Study Chair: |
Alan P. Lyss, MD |
Missouri Baptist Cancer Center |
|
|
| National Cancer Institute (NCI) |
| November 2008 |
| June 5, 2003 |
| November 25, 2008 |