S0220: Chemoradiotherapy Followed By Surgery and Docetaxel in Treating Patients With Pancoast Tumors
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: cisplatin Drug: docetaxel Drug: etoposide Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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) |
- 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 ]
| Estimated Enrollment: | 45 |
| Study Start Date: | July 2003 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer
Any of the following stages due to involvement of the superior sulcus:
- Stage IIB (T3, N0), IIIA (T3, N1), or IIIB (T4, N0-1)
- Newly diagnosed
- Primary bronchogenic
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:
- Single-level or multi-level ipsilateral or contralateral mediastinal nodal (N2 or N3) disease by mediastinoscopy, thoracoscopy, mediastinotomy, thoracotomy, or transbronchial Wang needle biopsy, regardless of whether enlarged nodes are visible or not on chest x-ray or CT scan
Supraclavicular (scalene) nodes
- Any nodes evident on physical exam must be biopsied by fine needle aspiration or open biopsy
- Left upper lobe tumors with left vocal cord paralysis by indirect laryngoscopy (presumes N2 nodes in the A-P window) NOTE: *Mediastinal exploration is not required for patients whose mediastinum is negative by both positron-emission tomography (PET) and CT scan
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
- Not specified
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
- Not specified
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
- Not specified
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
- No concurrent amifostine
Contacts and Locations
Show 154 Study Locations| 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 Regional Cancer Centre |
| Study Chair: | Alan P. Lyss, MD | Missouri Baptist Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Laurence H. Baker, Southwest Oncology Group - Group Chair's Office |
| ClinicalTrials.gov Identifier: | NCT00062439 History of Changes |
| Other Study ID Numbers: | CDR0000304777, U10CA032102, SWOG-S0220, ECOG-S0220, ACOSOG-SWOG-S0220, NCCTG-SWOG-S0220, CAN-NCIC-SWOG-S0220, CALGB-30501 |
| Study First Received: | June 5, 2003 |
| Last Updated: | July 18, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Southwest Oncology Group:
|
stage II non-small cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Pancoast Syndrome Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Etoposide phosphate Docetaxel Cisplatin Etoposide Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 16, 2013