Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Chemoradiotherapy Followed By Surgery and Docetaxel in Treating Patients With Pancoast Tumors

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed Not specified NCI SWOG-S0220 ECOG-S0220, ACOSOG-SWOG-S0220, NCCTG-SWOG-S0220, CAN-NCIC-SWOG-S0220, S0220, CALGB-30501, NCT00062439

Objectives

1. 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).
2. Determine overall survival of patients treated with this regimen.
3. Determine time to progression in patients treated with this regimen.
4. Determine confirmed and unconfirmed and complete and partial response during induction in patients treated with this regimen.
5. Determine the toxicity of this regimen in these patients.

Entry Criteria

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

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

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/mm³
• Platelet count at least 100,000/mm³

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 FEV₁ at least 2.0 L

  OR

• Predicted postresection FEV₁ 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

Expected Enrollment

A total of 45 patients will be accrued for this study.

Outcomes

Measurability of lesions
Objective status
Response
Performance status
Progression-free survival
Time to death

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.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Michael Kraut, MD, Protocol chair		Ph: 248-849-3541; 800-341-0801 Email: mkraut@providence-hospital.org

Eastern Cooperative Oncology Group

Tien Hoang, MD, Protocol chair		Ph: 608-263-4548; 800-622-8922

American College of Surgeons Oncology Group

Valerie Rusch, MD, FACS, Protocol chair		Ph: 212-639-8695; 800-525-2225

North Central Cancer Treatment Group

James Jett, MD, Protocol chair		Ph: 507-284-2511

NCIC-Clinical Trials Group

Scott Laurie, MD, FRCPC, Protocol chair		Ph: 613-737-7700 ext. 70173; 888-627-5346

Cancer and Leukemia Group B

Alan Lyss, MD, Protocol chair		Ph: 314-996-5514; 800-392-0936 Email: alyss@bjc.org

Registry Information
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)
Trial Start Date		2003-07-14
Trial Completion Date		2007-03-25 (estimated)
Registered in ClinicalTrials.gov		NCT00062439
Date Submitted to PDQ		2003-05-06
Information Last Verified		2008-02-09
NCI Grant/Contract Number		CA32102

Back to Top