Back to results

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

Primary Purpose

Lung Cancer

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

cisplatin

docetaxel

etoposide

conventional surgery

radiation therapy

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mobile Infirmary Medical Center
Poudre Valley Hospital
Mayo Clinic - Jacksonville
Rush-Copley Cancer Care Center
Joliet Oncology-Hematology Associates, Limited - West
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Regional Cancer Center at Memorial Medical Center
Carle Cancer Center at Carle Foundation Hospital
CCOP - Carle Cancer Center
Saint Anthony Memorial Health Centers
Holden Comprehensive Cancer Center at University of Iowa
Cancer Center of Kansas, PA - Chanute
Cancer Center of Kansas, PA - Dodge City
Cancer Center of Kansas, PA - El Dorado
Cancer Center of Kansas, PA - Kingman
Southwest Medical Center
Cancer Center of Kansas, PA - Newton
Cancer Center of Kansas, PA - Parsons
Cancer Center of Kansas, PA - Pratt
Cancer Center of Kansas, PA - Salina
Cancer Center of Kansas, PA - Wellington
Associates in Womens Health, PA - North Review
Cancer Center of Kansas, PA - Medical Arts Tower
Cancer Center of Kansas, PA - Wichita
CCOP - Wichita
Via Christi Cancer Center at Via Christi Regional Medical Center
Wesley Medical Center
Cancer Center of Kansas, PA - Winfield
Hickman Cancer Center at Bixby Medical Center
Saint Joseph Mercy Cancer Center
CCOP - Michigan Cancer Research Consortium
Battle Creek Health System Cancer Care Center
Mecosta County Medical Center
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Genesys Hurley Cancer Institute
Hurley Medical Center
Butterworth Hospital at Spectrum Health
CCOP - Grand Rapids
Lacks Cancer Center at Saint Mary's Health Care
Metro Health Hospital
Van Elslander Cancer Center at St. John Hospital and Medical Center
Holland Community Hospital
Foote Memorial Hospital
Borgess Medical Center
West Michigan Cancer Center
Bronson Methodist Hospital
Haematology-Oncology Associates of Ohio and Michigan, PC
Sparrow Regional Cancer Center
Community Cancer Center of Monroe
Mercy Memorial Hospital - Monroe
Hackley Hospital
Seton Cancer Institute at Saint Mary's - Saginaw
Providence Cancer Institute at Providence Hospital - Southfield Campus
Munson Medical Center
St. John Macomb Hospital
Duluth Clinic Cancer Center - Duluth
CCOP - Duluth
Miller - Dwan Medical Center
Mayo Clinic Cancer Center
Willmar Cancer Center at Rice Memorial Hospital
University of Mississippi Cancer Clinic
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Ellis Fischel Cancer Center at University of Missouri - Columbia
Arch Medical Services, Incorporated at Center for Cancer Care and Research
Missouri Baptist Cancer Center
CCOP - Montana Cancer Consortium
Hematology-Oncology Centers of the Northern Rockies - Billings
Northern Rockies Radiation Oncology Center
St. Vincent Healthcare Cancer Care Services
Billings Clinic - Downtown
Bozeman Deaconess Cancer Center
St. James Healthcare Cancer Care
Big Sky Oncology
Great Falls Clinic - Main Facility
Sletten Cancer Institute at Benefis Healthcare
St. Peter's Hospital
Glacier Oncology, PLLC
Kalispell Medical Oncology at KRMC
Kalispell Regional Medical Center
Community Medical Center
Guardian Oncology and Center for Wellness
Montana Cancer Specialists at Montana Cancer Center
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Wayne Memorial Hospital, Incorporated
Kinston Medical Specialists
Rutherford Hospital
Bismarck Cancer Center
Medcenter One Hospital Cancer Care Center
Mid Dakota Clinic, PC
St. Alexius Medical Center Cancer Center
Wood County Oncology Center
Charles M. Barrett Cancer Center at University Hospital
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Fremont Memorial Hospital
St. Rita's Medical Center
Lima Memorial Hospital
Northwest Ohio Oncology Center
St. Luke's Hospital
St. Charles Mercy Hospital
Toledo Clinic - Oregon
Firelands Regional Medical Center
North Coast Cancer Care, Incorporated
Flower Hospital Cancer Center
Mercy Hospital of Tiffin
Toledo Hospital
St. Vincent Mercy Medical Center
Medical University of Ohio Cancer Center
CCOP - Toledo Community Hospital
Toledo Clinic, Incorporated - Main Clinic
Fulton County Health Center
Northwest Cancer Specialists at Rose Quarter Cancer Center
AnMed Cancer Center
CCOP - Upstate Carolina
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
MBCCOP - Meharry Medical College - Nashville
American Fork Hospital
Sandra L. Maxwell Cancer Center
Logan Regional Hospital
Cottonwood Hospital Medical Center
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
Utah Valley Regional Medical Center - Provo
Dixie Regional Medical Center - East Campus
LDS Hospital
Utah Cancer Specialists at UCS Cancer Center
University of Virginia Cancer Center
Fredericksburg Oncology, Incorporated
Auburn Regional Center for Cancer Care
St. Joseph Cancer Center
Olympic Hematology and Oncology
Providence Centralia Hospital
St. Francis Hospital
Columbia Basin Hematology
Providence St. Peter Hospital Regional Cancer Center
Good Samaritan Cancer Center
Fred Hutchinson Cancer Research Center
Harborview Medical Center
Minor and James Medical, PLLC
Group Health Central Hospital
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Polyclinic First Hill
University Cancer Center at University of Washington Medical Center
Cancer Care Northwest - Spokane South
Franciscan Cancer Center at St. Joseph Medical Center
Allenmore Hospital
CCOP - Northwest
MultiCare Regional Cancer Center at Tacoma General Hospital
St. Clare Hospital
Northwest Cancer Specialists at Vancouver Cancer Center
Wenatchee Valley Medical Center
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Welch Cancer Center at Sheridan Memorial Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Etoposide, Cisplatin, Thoracic RT, Surgery, Docetaxel

Arm Description

Outcomes

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.

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

Secondary Outcome Measures

Adverse Events

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

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.

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.

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.

Full Information

NCT ID

NCT00062439

First Posted

June 5, 2003

Last Updated

October 30, 2013

Sponsor

SWOG Cancer Research 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

1. Study Identification

Unique Protocol Identification Number

NCT00062439

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

July 2003 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SWOG Cancer Research 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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

Keywords

stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Etoposide, Cisplatin, Thoracic RT, Surgery, Docetaxel

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

cisplatin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

docetaxel

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

etoposide

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

conventional surgery

Intervention Description

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.

Intervention Type

Radiation

Intervention Name(s)

radiation therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Description

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

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

Secondary Outcome Measure Information:

Title

Adverse Events

Description

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

Time Frame

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

Title

Overall Survival

Description

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.

Time Frame

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

Title

Progression-Free Survival at 3 Years

Description

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.

Title

Response

Description

Time Frame

After completion of induction therapy.

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials: