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Induction Chemoradiotherapy Followed by Surgical Resection for Non-small Cell Lung Cancer Involving the Superior Sulcus (Pancoast Tumors): A Phase II Trial

Phase 2
18 Years
Not Enrolling
Lung Cancer

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Trial Information

Induction Chemoradiotherapy Followed by Surgical Resection for Non-small Cell Lung Cancer Involving the Superior Sulcus (Pancoast Tumors): A Phase II Trial

OBJECTIVES: I. Assess the feasibility and toxic effects of 2 courses of cisplatin/etoposide
given concurrently with continuous, fractionated chest irradiation followed by surgical
resection and boost chemotherapy in patients with Pancoast tumors without mediastinal or
supraclavicular nodal involvement. II. Assess the objective response rate, resectability
rate, and proportion of patients free of microscopic residual disease after such treatment.

OUTLINE: All patients receive Induction on Regimen A and, in the absence of progression,
proceed to Regimen B, then C. Patients who refuse or are medically unfit for surgery
following Regimen A proceed directly to Regimen C. Regimen A: 2-Drug Combination
Chemotherapy plus Radiotherapy. Cisplatin, CDDP, NSC-119875; Etoposide, VP-16, NSC-141540;
plus irradiation of the tumor and ipsilateral supraclavicular region using megavoltage
equipment (photons with peak energies of 4-15 MV). Regimen B: Surgery. Tumor resection.
Regimen C: 2-Drug Combination Chemotherapy. CDDP; VP-16.

PROJECTED ACCRUAL: 99 patients will be accrued over 2-4 years.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically proven non-small cell lung cancer
of any type Selected stage IIIA/B disease (T3-4, N0-1, M0) with superior sulcus
involvement, including: Apical tumor without rib or vertebral body involvement, with
Pancoast syndrome Superior sulcus tumor with involvement of the chest wall (T3) and
usually ribs 1 and 2 by CT or MRI, with or without Pancoast syndrome Superior sulcus tumor
with involvement of vertebral body or subclavian vessels (T4) by CT or MRI, with or
without Pancoast syndrome Pancoast syndrome defined: Arm or shoulder pain Neurologic
findings corresponding to C8 and T1 roots or the inferior trunk of the brachial plexus,
with or without Horner's syndrome Single primary lesion that is measurable or evaluable by
chest x-ray or CT required Pleural effusions allowed only if: Transudate with negative
cytology on 2 separate thoracenteses if present before mediastinoscopy or exploratory
thoracotomy Transudate or exudate with negative cytology on a single thoracentesis if
present only after preregistration exploratory or staging thoracotomy OR Present on CT but
not chest x-ray AND considered too small to tap under CT or ultrasound guidance
Thoracoscopy to assess pleural metastases strongly recommended No mediastinal or
supraclavicular nodal involvement (N2-3) established by mediastinoscopy, mediastinotomy,
thoracoscopy, or thoracotomy No documented single- or multi-level ipsilateral or
contralateral mediastinal nodes whether or not enlarged nodes visible on chest x-ray or CT
AP window nodes (level 5) causing vocal cord paralysis considered N2 disease in patients
with a distinct primary tumor in the left upper lobe Paralysis documented by indirect
laryngoscopy No evidence of distant metastases on the following: Chest CT, preferably with
contrast Thoracic spine MRI strongly recommended if CT suggests vertebral body invasion
Abdominal CT including liver and adrenals, preferably with contrast Biopsy or aspiration
cytology required to confirm diagnosis of any CT or MRI abnormality MRI and ultrasound
sufficient to diagnose benign cysts or hemangiomas Brain CT or MRI with contrast Bone scan
with x-rays or MRI, and/or aspiration cytology of any abnormality (unless related to chest
wall extension of primary) No pericardial effusions or superior vena cava syndrome Patient
considered candidate for potential pulmonary resection by attending thoracic surgeon

PATIENT CHARACTERISTICS: Age: Adult Performance status: SWOG 0-2 Albumin at least 0.85
times normal and no greater than 10% tumor-related weight loss required in patients with
performance status 2 Hematopoietic: WBC at least 4,000 Platelets at least normal Hepatic:
(unless abnormality due to documented benign disease) Bilirubin no greater than 1.5 times
normal ALT or AST no greater than 1.5 times normal Renal: Creatinine clearance
(calculated) at least 50 mL/min Cardiovascular: No poorly controlled disease, e.g.:
Myocardial infarction within 3 months Active angina Arrhythmia Clinically evident
congestive heart failure Pulmonary: FEV1 at least 2.0 liters OR Predicted postresection
FEV1 greater than 800 mL based on quantitative lung V/Q scan DLCO at least 50% of
predicted (corrected for hemoglobin) and recommended if pneumonectomy planned Other: No
symptomatic peripheral neuropathy No peptic ulcer disease unless medically controlled
Acceptance of potential worsening of any existing clinical hearing loss No second
malignancy within 5 years except: Adequately treated nonmelanomatous skin cancer
Adequately treated in situ cervical cancer No pregnant or nursing women Effective
contraception required of fertile women

PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy for lung cancer Prior
exploratory thoracotomy allowed only for diagnostic or staging purposes

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

resectibility rate

Outcome Time Frame:

9-12 weeks after study entry

Safety Issue:


Principal Investigator

Valerie W. Rusch, MD, FACS

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

April 1995

Completion Date:

July 2004

Related Keywords:

  • Lung Cancer
  • 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
  • adenosquamous cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Vanderbilt Cancer Center Nashville, Tennessee  37232-6838