AzTrials
AzTrials

Lung CancerPhase 2NCT00062439

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

A Phase 2 study testing cisplatin, docetaxel and etoposide in people with Lung Cancer, run by SWOG Cancer Research Network at 154 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Lung Cancer
What is being tested?
cisplatin, docetaxel and etoposide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
154 sitesUnited States
Study dates
Jul 2003to Dec 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

154 sites in 1 country.

154 sites in 1 country

United States154 sites

  • Hickman Cancer Center at Bixby Medical Center

    Adrian, Michigan, 49221

  • American Fork Hospital

    American Fork, Utah, 84003

  • AnMed Cancer Center

    Anderson, South Carolina, 29621

  • Saint Joseph Mercy Cancer Center

    Ann Arbor, Michigan, 48106-0995

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • Auburn Regional Center for Cancer Care

    Auburn, Washington, 98002

  • Rush-Copley Cancer Care Center

    Aurora, Illinois, 60507

  • Battle Creek Health System Cancer Care Center

    Battle Creek, Michigan, 49017

  • St. Joseph Cancer Center

    Bellingham, Washington, 98225

  • Mecosta County Medical Center

    Big Rapids, Michigan, 49307

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • St. Vincent Healthcare Cancer Care Services

    Billings, Montana, 59101

  • Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Bismarck Cancer Center

    Bismarck, North Dakota, 58501

  • Medcenter One Hospital Cancer Care Center

    Bismarck, North Dakota, 58501

  • Mid Dakota Clinic, PC

    Bismarck, North Dakota, 58501

  • St. Alexius Medical Center Cancer Center

    Bismarck, North Dakota, 58502

  • Wood County Oncology Center

    Bowling Green, Ohio, 43402

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • Olympic Hematology and Oncology

    Bremerton, Washington, 98310

  • St. James Healthcare Cancer Care

    Butte, Montana, 59701

  • Sandra L. Maxwell Cancer Center

    Cedar City, Utah, 84720

  • Providence Centralia Hospital

    Centralia, Washington, 98531-9027

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas, 66720

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267

  • Veterans Affairs Medical Center - Columbia (Truman Memorial)

    Columbia, Missouri, 65201

  • Ellis Fischel Cancer Center at University of Missouri - Columbia

    Columbia, Missouri, 65203

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

    Columbus, Ohio, 43210-1240

  • Oakwood Cancer Center at Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48123-2500

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas, 67801

  • Duluth Clinic Cancer Center - Duluth

    Duluth, Minnesota, 55805-1983

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • Miller - Dwan Medical Center

    Duluth, Minnesota, 55805

  • Cancer Center of Kansas, PA - El Dorado

    El Dorado, Kansas, 67042

  • St. Francis Hospital

    Federal Way, Washington, 98003

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Fredericksburg Oncology, Incorporated

    Fredericksburg, Virginia, 22401

  • Fremont Memorial Hospital

    Fremont, Ohio, 43420

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Butterworth Hospital at Spectrum Health

    Grand Rapids, Michigan, 49503

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • Lacks Cancer Center at Saint Mary's Health Care

    Grand Rapids, Michigan, 49503

  • Metro Health Hospital

    Grand Rapids, Michigan, 49506

  • Big Sky Oncology

    Great Falls, Montana, 59405-5309

  • Great Falls Clinic - Main Facility

    Great Falls, Montana, 59405

  • Sletten Cancer Institute at Benefis Healthcare

    Great Falls, Montana, 59405

  • Study site

    Great Falls, Montana, 59405

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Holland Community Hospital

    Holland, Michigan, 49423

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242-1002

  • Foote Memorial Hospital

    Jackson, Michigan, 49201

  • University of Mississippi Cancer Clinic

    Jackson, Mississippi, 39216

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • Joliet Oncology-Hematology Associates, Limited - West

    Joliet, Illinois, 60435

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology at KRMC

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Columbia Basin Hematology

    Kennewick, Washington, 99336

  • Cancer Center of Kansas, PA - Kingman

    Kingman, Kansas, 67068

  • Kinston Medical Specialists

    Kinston, North Carolina, 28501

  • Haematology-Oncology Associates of Ohio and Michigan, PC

    Lambertville, Michigan, 48144

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48912-1811

  • Southwest Medical Center

    Liberal, Kansas, 67901

  • St. Rita's Medical Center

    Lima, Ohio, 45801

  • Lima Memorial Hospital

    Lima, Ohio, 45804

  • Logan Regional Hospital

    Logan, Utah, 84321

  • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

    Madison, Wisconsin, 53792-6164

  • Northwest Ohio Oncology Center

    Maumee, Ohio, 43537

  • St. Luke's Hospital

    Maumee, Ohio, 43537

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Maywood, Illinois, 60153

  • Saint Anthony Memorial Health Centers

    Michigan City, Indiana, 46360

  • Community Medical Center

    Missoula, Montana, 59801

  • Guardian Oncology and Center for Wellness

    Missoula, Montana, 59804

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana, 59807-7877

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana, 59807

  • Mobile Infirmary Medical Center

    Mobile, Alabama, 36652-2144

  • Community Cancer Center of Monroe

    Monroe, Michigan, 48162

  • Mercy Memorial Hospital - Monroe

    Monroe, Michigan, 48162

  • Cottonwood Hospital Medical Center

    Murray, Utah, 84107

  • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center

    Murray, Utah, 84157

  • Hackley Hospital

    Muskegon, Michigan, 49442

  • MBCCOP - Meharry Medical College - Nashville

    Nashville, Tennessee, 37208-3599

  • Cancer Center of Kansas, PA - Newton

    Newton, Kansas, 67114

  • Val and Ann Browning Cancer Center at McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • Providence St. Peter Hospital Regional Cancer Center

    Olympia, Washington, 98506-5166

  • St. Charles Mercy Hospital

    Oregon, Ohio, 43616

  • Toledo Clinic - Oregon

    Oregon, Ohio, 43616

  • Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital

    Parkersburg, West Virginia, 26102

  • Cancer Center of Kansas, PA - Parsons

    Parsons, Kansas, 67357

  • Northwest Cancer Specialists at Rose Quarter Cancer Center

    Portland, Oregon, 97227

  • Cancer Center of Kansas, PA - Pratt

    Pratt, Kansas, 67124

  • Utah Valley Regional Medical Center - Provo

    Provo, Utah, 84604

  • Good Samaritan Cancer Center

    Puyallup, Washington, 98372

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Rutherford Hospital

    Rutherfordton, North Carolina, 28139

  • Seton Cancer Institute at Saint Mary's - Saginaw

    Saginaw, Michigan, 48601

  • Cancer Center of Kansas, PA - Salina

    Salina, Kansas, 67042

  • LDS Hospital

    Salt Lake City, Utah, 84103

  • Utah Cancer Specialists at UCS Cancer Center

    Salt Lake City, Utah, 84106

  • Firelands Regional Medical Center

    Sandusky, Ohio, 44870

  • North Coast Cancer Care, Incorporated

    Sandusky, Ohio, 44870

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98104

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Minor and James Medical, PLLC

    Seattle, Washington, 98104

  • Group Health Central Hospital

    Seattle, Washington, 98112

  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

    Seattle, Washington, 98122-4307

  • Polyclinic First Hill

    Seattle, Washington, 98122

  • University Cancer Center at University of Washington Medical Center

    Seattle, Washington, 98195-6043

  • Welch Cancer Center at Sheridan Memorial Hospital

    Sheridan, Wyoming, 82801

  • Providence Cancer Institute at Providence Hospital - Southfield Campus

    Southfield, Michigan, 48075

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Cancer Care Northwest - Spokane South

    Spokane, Washington, 99202

  • Regional Cancer Center at Memorial Medical Center

    Springfield, Illinois, 62781-0001

  • Missouri Baptist Cancer Center

    St Louis, Missouri, 63131

  • Arch Medical Services, Incorporated at Center for Cancer Care and Research

    St Louis, Missouri, 63141

  • Dixie Regional Medical Center - East Campus

    St. George, Utah, 84770

  • Flower Hospital Cancer Center

    Sylvania, Ohio, 43560

  • Franciscan Cancer Center at St. Joseph Medical Center

    Tacoma, Washington, 98405-3004

  • Allenmore Hospital

    Tacoma, Washington, 98405

  • CCOP - Northwest

    Tacoma, Washington, 98405

  • MultiCare Regional Cancer Center at Tacoma General Hospital

    Tacoma, Washington, 98405

  • St. Clare Hospital

    Tacoma, Washington, 98499

  • Mercy Hospital of Tiffin

    Tiffin, Ohio, 44883

  • Toledo Hospital

    Toledo, Ohio, 43606

  • St. Vincent Mercy Medical Center

    Toledo, Ohio, 43608

  • Medical University of Ohio Cancer Center

    Toledo, Ohio, 43614

  • CCOP - Toledo Community Hospital

    Toledo, Ohio, 43617

  • Toledo Clinic, Incorporated - Main Clinic

    Toledo, Ohio, 43623

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Carle Cancer Center at Carle Foundation Hospital

    Urbana, Illinois, 61801

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • Northwest Cancer Specialists at Vancouver Cancer Center

    Vancouver, Washington, 98684

  • St. John Macomb Hospital

    Warren, Michigan, 48093

  • Fulton County Health Center

    Wauseon, Ohio, 43567

  • Cancer Center of Kansas, PA - Wellington

    Wellington, Kansas, 67152

  • Wenatchee Valley Medical Center

    Wenatchee, Washington, 98801-2028

  • Associates in Womens Health, PA - North Review

    Wichita, Kansas, 67203

  • Cancer Center of Kansas, PA - Medical Arts Tower

    Wichita, Kansas, 67208

  • Cancer Center of Kansas, PA - Wichita

    Wichita, Kansas, 67214

  • CCOP - Wichita

    Wichita, Kansas, 67214

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Wesley Medical Center

    Wichita, Kansas, 67214

  • Willmar Cancer Center at Rice Memorial Hospital

    Willmar, Minnesota, 56201

  • Cancer Center of Kansas, PA - Winfield

    Winfield, Kansas, 67156

Other trials in United States

About this study

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)

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.

Read the 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.

Conditions
Lung Cancer
Being tested
cisplatin, docetaxel, etoposide, conventional surgery, radiation therapy
Keywords
stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cisplatinDrug

    During induction:50 mg/m2,IV on Days 1, 8, 29 \& 36. In any appropriate vehicle over 60 minutes

  • docetaxelDrug

    During consolidation: 75 mg/m2 IV on Day 1, every 21 days for 3 cycles over 60 minutes

  • etoposideDrug

    During induction: 50 mg/m2, IV on Days 1 - 5 Days 29 - 33. In 250 ml of NS over 60 minutes.

  • conventional surgeryProcedure or 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 therapyRadiation

    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.

Study groups in NCT00062439
Study groupRoleWhat they receive
Etoposide, Cisplatin, Thoracic RT, Surgery, DocetaxelExperimentalNot described
Receives: Drug: cisplatin; Drug: docetaxel; Drug: etoposide; Procedure: conventional surgery; Radiation: radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Feasibility was assessed by estimating the percentage of participants who would be able to complete the entire treatment regimen.

    Measured: 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

Secondary outcomes (4)

  1. Adverse Events

    Only adverse events that are possibly, probably or definitely related to study drug are reported.

    Measured: Weekly for the first 13 weeks, then every 3 weeks for the next 6 weeks.

  2. Overall Survival

    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.

    Measured: daily for 12 weeks then every 3 weeks for 12 weeks, then every 6 months thereafter.

  3. Progression-Free Survival at 3 Years

    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.

    Measured: 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.

  4. Response

    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.

    Measured: After completion of induction therapy.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2003 (estimated)
  2. Study startJul 2003
  3. Primary completionDec 2010
  4. Study completionDec 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00062439
Sponsor's protocol ID
CDR0000304777
Other IDs
U10CA032102, S0220
Status last verified
Oct 2013
First submitted
5 Jun 2003
Last updated
25 Nov 2013
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cisplatin, docetaxel and etoposide in people with Lung Cancer, run by SWOG Cancer Research Network at 154 sites in United States.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 154 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00062439.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2013.

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