Clinical trial · Interventional

S0220: 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)

NCT00062439CI-TRIAL-00012741completedPhase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Lung Cancer	Malignant Lung Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (5)

Intervention	Type	Mapped drug	Match
cisplatin	Drug	Cisplatin	ALIAS
conventional surgery	Procedure	—	UNRESOLVED
docetaxel	Drug	Docetaxel	ALIAS
etoposide	Drug	Etoposide	ALIAS
radiation therapy	Radiation	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Etoposide, Cisplatin, Thoracic RT, Surgery, Docetaxel
interventionNames
1. Drug: cisplatin
2. Drug: docetaxel
3. Drug: etoposide
4. Procedure: conventional surgery
5. Radiation: radiation therapy

Primary outcomes (1)

measure
Feasibility of Treating Patients With Stage IIB/IIIB Pancoast Tumors With a Regimen of Cisplatin and Etoposide Plus Concurrent Radiotherapy Followed by Surgical Resection Followed by Consolidation Therapy With Docetaxel.
timeFrame
After completion of 5 weeks of radiotherapy given concurrently with cisplatin+etoposide, surgery + 8 weeks of recovery time, and 6 weeks of consolidation therapy with docetaxel
description
Feasibility was assessed by estimating the percentage of participants who would be able to complete the entire treatment regimen.

Secondary outcomes (4)

Eligibility

Eligibility (as posted)

Sex: All

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Jul 1, 2003
Primary completion: Dec 1, 2010
Completion: Dec 1, 2010
First posted: Jun 6, 2003
Last update posted: Nov 25, 2013
Results first posted: Nov 25, 2013
Enrollment: 46 (actual)
Lead sponsor: SWOG Cancer Research Network NETWORK
Collaborators: National Cancer Institute (NCI); Eastern Cooperative Oncology Group; American College of Surgeons; North Central Cancer Treatment Group; NCIC Clinical Trials Group; Cancer and Leukemia Group B
Keywords: stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer

Data updated 22 days agoSource updated Nov 25, 2013source: clinicaltrials

Locations

Locations by country (154)

Country	Sites	Recruiting
United States	154	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.