S0220: Chemoradiotherapy Followed By Surgery and Docetaxel in Treating Patients With Pancoast Tumors

This study has been completed.
Sponsor:
Collaborators:
Eastern Cooperative Oncology Group
American College of Surgeons
North Central Cancer Treatment Group
NCIC Clinical Trials Group
Cancer and Leukemia Group B
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00062439
First received: June 5, 2003
Last updated: October 30, 2013
Last verified: October 2013
  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: conventional surgery
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
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)

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • 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. [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Feasibility was assessed by estimating the percentage of participants who would be able to complete the entire treatment regimen.


Secondary Outcome Measures:
  • Adverse Events [ Time Frame: Weekly for the first 13 weeks, then every 3 weeks for the next 6 weeks. ] [ Designated as safety issue: Yes ]
    Only adverse events that are possibly, probably or definitely related to study drug are reported.

  • Overall Survival [ Time Frame: daily for 12 weeks then every 3 weeks for 12 weeks, then every 6 months thereafter. ] [ Designated as safety issue: No ]
    The duration from the date of enrollment until the date of death due to any cause. Patients last known to be alive were censored at the date of last contact.

  • Progression-Free Survival at 3 Years [ Time Frame: At the completion of induction therapy, then again 4 weeks after the completion of consolidation therapy, then every 3 months for 2 years, then every 6 months until up to a maximum of 5 years after enrollment. ] [ Designated as safety issue: No ]
    Duration from date of enrollment to date of progression (per RECIST), symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at the date of last contact.

  • Response [ Time Frame: After completion of induction therapy. ] [ Designated as safety issue: No ]
    Response was defined as achieving a confirmed or unconfirmed complete or partial response as determined by RECIST. Patients who dropped out due to any cause prior to getting their response assessment were counted as non-responders. A complete response (CR) was defined as disappearance of all disease. A partial response was defined as a >= 30% decrease in the sum of longest diameters of target lesions. A CR or PR was defined as confirmed if two consecutive determinations were documented at least 4 weeks apart.


Enrollment: 46
Study Start Date: July 2003
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Etoposide, Cisplatin, Thoracic RT, Surgery, Docetaxel Drug: cisplatin
During induction:50 mg/m2,IV on Days 1, 8, 29 & 36. In any appropriate vehicle over 60 minutes
Drug: docetaxel
During consolidation: 75 mg/m2 IV on Day 1, every 21 days for 3 cycles over 60 minutes
Drug: etoposide
During induction: 50 mg/m2, IV on Days 1 - 5 Days 29 - 33. In 250 ml of NS over 60 minutes.
Procedure: conventional surgery
If, based upon the evaluation in Section 7.4a, there is no evidence of progression (see Section 10.2d for definition), patients will proceed to the next appropriate step: Registration #2 and surgery followed by Registration #3 and additional chemotherapy (Sections 7.5 and 7.6). Response determinations (CR,PR, SD) will be required. If criteria for progressive measurable or nonmeasurable disease (see Section 10.0) are met, the patient will then be removed from protocol treatment and receive follow-up according to the schedule. Surgery will be performed 3 - 7 weeks after completion of chemoradiotherapy.
Radiation: radiation therapy
Radiotherapy is to begin within 24 hours following the start of chemotherapy. Day 1 of radiotherapy must be a Monday, Tuesday or Wednesday, but no later in the week to insure simultaneous therapy for the majority of each chemotherapy cycle. The total dose to the prescription point will be 4,500 cGy given in 25 fractions. The patient will be treated with one fraction per day with all fields treated per day. 180 cGy will be delivered to the isocenter.

Detailed Description:

OBJECTIVES:

  • Determine the feasibility 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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00062439

  Show 154 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Eastern Cooperative Oncology Group
American College of Surgeons
North Central Cancer Treatment Group
NCIC Clinical Trials Group
Cancer and Leukemia Group B
Investigators
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: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00062439     History of Changes
Other Study ID Numbers: CDR0000304777, U10CA032102, S0220
Study First Received: June 5, 2003
Results First Received: November 15, 2012
Last Updated: October 30, 2013
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 July 29, 2014