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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)

Phase 2
Open (Enrolling)
Lung Cancer

Thank you

Trial Information

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)


- 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

- 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.


- 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.

Inclusion Criteria


- 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



- 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


- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- 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


- Creatinine clearance at least 50 mL/min


- No myocardial infarction within the past 3 months

- No active angina

- No unstable heart rhythms

- No clinically evident congestive heart failure


- Preresection FEV_1 at least 2.0 L OR

- Predicted postresection FEV_1 greater than 1.0 L


- 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


Biologic therapy

- No concurrent colony-stimulating factors during chemoradiotherapy or course 1 of
consolidation therapy


- No prior chemotherapy for lung cancer

Endocrine therapy

- Not specified


- No prior radiotherapy to the neck or thorax

- No concurrent intensity-modulated radiotherapy


- Prior exploratory thoracotomy allowed only for diagnosis or staging purposes


- No concurrent amifostine

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Measurability of lesions

Safety Issue:


Principal Investigator

Michael J. Kraut, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Providence Cancer Institute at Providence Hospital - Southfield Campus


United States: Federal Government

Study ID:




Start Date:

July 2003

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage II non-small cell lung cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Pancoast Syndrome



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