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

• Sponsor: Southwest Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00062439
• Collaborator: National Cancer Institute (NCI) (NIH), Eastern Cooperative Oncology Group (Other), American College of Surgeons (Other), North Central Cancer Treatment Group (Other), NCIC Clinical Trials Group (Other), Cancer and Leukemia Group B (Other)
• Enrollment: 46
• Locations: 154
• Arm: 1
• Duration (Months): 89
• Patients Per Site: 0.3
• Patients Per Site Per Month: 0

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Drug: cisplatin; Drug: docetaxel; Drug: etoposide; Procedure: conventional surgery; Radiation: radiation therapy	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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)
• Study Start Date: Jul 1, 2003
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

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. [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]

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

Secondary Outcome Measures

1. Adverse Events [Weekly for the first 13 weeks, then every 3 weeks for the next 6 weeks.]

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

2. Overall Survival [daily for 12 weeks then every 3 weeks for 12 weeks, then every 6 months thereafter.]

   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.

3. Progression-Free Survival at 3 Years [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.]

   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.

4. Response [After completion of induction therapy.]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Mobile Infirmary Medical Center	Mobile	Alabama	United States	36652-2144
2	Poudre Valley Hospital	Fort Collins	Colorado	United States	80524
3	Mayo Clinic - Jacksonville	Jacksonville	Florida	United States	32224
4	Rush-Copley Cancer Care Center	Aurora	Illinois	United States	60507
5	Joliet Oncology-Hematology Associates, Limited - West	Joliet	Illinois	United States	60435
6	Cardinal Bernardin Cancer Center at Loyola University Medical Center	Maywood	Illinois	United States	60153
7	Regional Cancer Center at Memorial Medical Center	Springfield	Illinois	United States	62781-0001
8	Carle Cancer Center at Carle Foundation Hospital	Urbana	Illinois	United States	61801
9	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
10	Saint Anthony Memorial Health Centers	Michigan City	Indiana	United States	46360
11	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa	United States	52242-1002
12	Cancer Center of Kansas, PA - Chanute	Chanute	Kansas	United States	66720
13	Cancer Center of Kansas, PA - Dodge City	Dodge City	Kansas	United States	67801
14	Cancer Center of Kansas, PA - El Dorado	El Dorado	Kansas	United States	67042
15	Cancer Center of Kansas, PA - Kingman	Kingman	Kansas	United States	67068
16	Southwest Medical Center	Liberal	Kansas	United States	67901
17	Cancer Center of Kansas, PA - Newton	Newton	Kansas	United States	67114
18	Cancer Center of Kansas, PA - Parsons	Parsons	Kansas	United States	67357
19	Cancer Center of Kansas, PA - Pratt	Pratt	Kansas	United States	67124
20	Cancer Center of Kansas, PA - Salina	Salina	Kansas	United States	67042
21	Cancer Center of Kansas, PA - Wellington	Wellington	Kansas	United States	67152
22	Associates in Womens Health, PA - North Review	Wichita	Kansas	United States	67203
23	Cancer Center of Kansas, PA - Medical Arts Tower	Wichita	Kansas	United States	67208
24	Cancer Center of Kansas, PA - Wichita	Wichita	Kansas	United States	67214
25	CCOP - Wichita	Wichita	Kansas	United States	67214
26	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas	United States	67214
27	Wesley Medical Center	Wichita	Kansas	United States	67214
28	Cancer Center of Kansas, PA - Winfield	Winfield	Kansas	United States	67156
29	Hickman Cancer Center at Bixby Medical Center	Adrian	Michigan	United States	49221
30	Saint Joseph Mercy Cancer Center	Ann Arbor	Michigan	United States	48106-0995
31	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan	United States	48106
32	Battle Creek Health System Cancer Care Center	Battle Creek	Michigan	United States	49017
33	Mecosta County Medical Center	Big Rapids	Michigan	United States	49307
34	Oakwood Cancer Center at Oakwood Hospital and Medical Center	Dearborn	Michigan	United States	48123-2500
35	Genesys Hurley Cancer Institute	Flint	Michigan	United States	48503
36	Hurley Medical Center	Flint	Michigan	United States	48503
37	Butterworth Hospital at Spectrum Health	Grand Rapids	Michigan	United States	49503
38	CCOP - Grand Rapids	Grand Rapids	Michigan	United States	49503
39	Lacks Cancer Center at Saint Mary's Health Care	Grand Rapids	Michigan	United States	49503
40	Metro Health Hospital	Grand Rapids	Michigan	United States	49506
41	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan	United States	48236
42	Holland Community Hospital	Holland	Michigan	United States	49423
43	Foote Memorial Hospital	Jackson	Michigan	United States	49201
44	Borgess Medical Center	Kalamazoo	Michigan	United States	49001
45	West Michigan Cancer Center	Kalamazoo	Michigan	United States	49007-3731
46	Bronson Methodist Hospital	Kalamazoo	Michigan	United States	49007
47	Haematology-Oncology Associates of Ohio and Michigan, PC	Lambertville	Michigan	United States	48144
48	Sparrow Regional Cancer Center	Lansing	Michigan	United States	48912-1811
49	Community Cancer Center of Monroe	Monroe	Michigan	United States	48162
50	Mercy Memorial Hospital - Monroe	Monroe	Michigan	United States	48162
51	Hackley Hospital	Muskegon	Michigan	United States	49442
52	Seton Cancer Institute at Saint Mary's - Saginaw	Saginaw	Michigan	United States	48601
53	Providence Cancer Institute at Providence Hospital - Southfield Campus	Southfield	Michigan	United States	48075
54	Munson Medical Center	Traverse City	Michigan	United States	49684
55	St. John Macomb Hospital	Warren	Michigan	United States	48093
56	Duluth Clinic Cancer Center - Duluth	Duluth	Minnesota	United States	55805-1983
57	CCOP - Duluth	Duluth	Minnesota	United States	55805
58	Miller - Dwan Medical Center	Duluth	Minnesota	United States	55805
59	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
60	Willmar Cancer Center at Rice Memorial Hospital	Willmar	Minnesota	United States	56201
61	University of Mississippi Cancer Clinic	Jackson	Mississippi	United States	39216
62	Veterans Affairs Medical Center - Columbia (Truman Memorial)	Columbia	Missouri	United States	65201
63	Ellis Fischel Cancer Center at University of Missouri - Columbia	Columbia	Missouri	United States	65203
64	Arch Medical Services, Incorporated at Center for Cancer Care and Research	Saint Louis	Missouri	United States	63141
65	Missouri Baptist Cancer Center	St. Louis	Missouri	United States	63131
66	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
67	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana	United States	59101
68	Northern Rockies Radiation Oncology Center	Billings	Montana	United States	59101
69	St. Vincent Healthcare Cancer Care Services	Billings	Montana	United States	59101
70	Billings Clinic - Downtown	Billings	Montana	United States	59107-7000
71	Bozeman Deaconess Cancer Center	Bozeman	Montana	United States	59715
72	St. James Healthcare Cancer Care	Butte	Montana	United States	59701
73	Big Sky Oncology	Great Falls	Montana	United States	59405-5309
74	Great Falls Clinic - Main Facility	Great Falls	Montana	United States	59405
75	Sletten Cancer Institute at Benefis Healthcare	Great Falls	Montana	United States	59405
76		Great Falls	Montana	United States	59405
77	St. Peter's Hospital	Helena	Montana	United States	59601
78	Glacier Oncology, PLLC	Kalispell	Montana	United States	59901
79	Kalispell Medical Oncology at KRMC	Kalispell	Montana	United States	59901
80	Kalispell Regional Medical Center	Kalispell	Montana	United States	59901
81	Community Medical Center	Missoula	Montana	United States	59801
82	Guardian Oncology and Center for Wellness	Missoula	Montana	United States	59804
83	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana	United States	59807-7877
84	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana	United States	59807
85	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina	United States	27534
86	Kinston Medical Specialists	Kinston	North Carolina	United States	28501
87	Rutherford Hospital	Rutherfordton	North Carolina	United States	28139
88	Bismarck Cancer Center	Bismarck	North Dakota	United States	58501
89	Medcenter One Hospital Cancer Care Center	Bismarck	North Dakota	United States	58501
90	Mid Dakota Clinic, PC	Bismarck	North Dakota	United States	58501
91	St. Alexius Medical Center Cancer Center	Bismarck	North Dakota	United States	58502
92	Wood County Oncology Center	Bowling Green	Ohio	United States	43402
93	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio	United States	45267
94	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center	Columbus	Ohio	United States	43210-1240
95	Fremont Memorial Hospital	Fremont	Ohio	United States	43420
96	St. Rita's Medical Center	Lima	Ohio	United States	45801
97	Lima Memorial Hospital	Lima	Ohio	United States	45804
98	Northwest Ohio Oncology Center	Maumee	Ohio	United States	43537
99	St. Luke's Hospital	Maumee	Ohio	United States	43537
100	St. Charles Mercy Hospital	Oregon	Ohio	United States	43616
101	Toledo Clinic - Oregon	Oregon	Ohio	United States	43616
102	Firelands Regional Medical Center	Sandusky	Ohio	United States	44870
103	North Coast Cancer Care, Incorporated	Sandusky	Ohio	United States	44870
104	Flower Hospital Cancer Center	Sylvania	Ohio	United States	43560
105	Mercy Hospital of Tiffin	Tiffin	Ohio	United States	44883
106	Toledo Hospital	Toledo	Ohio	United States	43606
107	St. Vincent Mercy Medical Center	Toledo	Ohio	United States	43608
108	Medical University of Ohio Cancer Center	Toledo	Ohio	United States	43614
109	CCOP - Toledo Community Hospital	Toledo	Ohio	United States	43617
110	Toledo Clinic, Incorporated - Main Clinic	Toledo	Ohio	United States	43623
111	Fulton County Health Center	Wauseon	Ohio	United States	43567
112	Northwest Cancer Specialists at Rose Quarter Cancer Center	Portland	Oregon	United States	97227
113	AnMed Cancer Center	Anderson	South Carolina	United States	29621
114	CCOP - Upstate Carolina	Spartanburg	South Carolina	United States	29303
115	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina	United States	29303
116	MBCCOP - Meharry Medical College - Nashville	Nashville	Tennessee	United States	37208-3599
117	American Fork Hospital	American Fork	Utah	United States	84003
118	Sandra L. Maxwell Cancer Center	Cedar City	Utah	United States	84720
119	Logan Regional Hospital	Logan	Utah	United States	84321
120	Cottonwood Hospital Medical Center	Murray	Utah	United States	84107
121	Jon and Karen Huntsman Cancer Center at Intermountain Medical Center	Murray	Utah	United States	84157
122	Val and Ann Browning Cancer Center at McKay-Dee Hospital Center	Ogden	Utah	United States	84403
123	Utah Valley Regional Medical Center - Provo	Provo	Utah	United States	84604
124	Dixie Regional Medical Center - East Campus	Saint George	Utah	United States	84770
125	LDS Hospital	Salt Lake City	Utah	United States	84103
126	Utah Cancer Specialists at UCS Cancer Center	Salt Lake City	Utah	United States	84106
127	University of Virginia Cancer Center	Charlottesville	Virginia	United States	22908
128	Fredericksburg Oncology, Incorporated	Fredericksburg	Virginia	United States	22401
129	Auburn Regional Center for Cancer Care	Auburn	Washington	United States	98002
130	St. Joseph Cancer Center	Bellingham	Washington	United States	98225
131	Olympic Hematology and Oncology	Bremerton	Washington	United States	98310
132	Providence Centralia Hospital	Centralia	Washington	United States	98531-9027
133	St. Francis Hospital	Federal Way	Washington	United States	98003
134	Columbia Basin Hematology	Kennewick	Washington	United States	99336
135	Providence St. Peter Hospital Regional Cancer Center	Olympia	Washington	United States	98506-5166
136	Good Samaritan Cancer Center	Puyallup	Washington	United States	98372
137	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98104
138	Harborview Medical Center	Seattle	Washington	United States	98104
139	Minor and James Medical, PLLC	Seattle	Washington	United States	98104
140	Group Health Central Hospital	Seattle	Washington	United States	98112
141	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington	United States	98122-4307
142	Polyclinic First Hill	Seattle	Washington	United States	98122
143	University Cancer Center at University of Washington Medical Center	Seattle	Washington	United States	98195-6043
144	Cancer Care Northwest - Spokane South	Spokane	Washington	United States	99202
145	Franciscan Cancer Center at St. Joseph Medical Center	Tacoma	Washington	United States	98405-3004
146	Allenmore Hospital	Tacoma	Washington	United States	98405
147	CCOP - Northwest	Tacoma	Washington	United States	98405
148	MultiCare Regional Cancer Center at Tacoma General Hospital	Tacoma	Washington	United States	98405
149	St. Clare Hospital	Tacoma	Washington	United States	98499
150	Northwest Cancer Specialists at Vancouver Cancer Center	Vancouver	Washington	United States	98684
151	Wenatchee Valley Medical Center	Wenatchee	Washington	United States	98801-2028
152	Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital	Parkersburg	West Virginia	United States	26102
153	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center	Madison	Wisconsin	United States	53792-6164
154	Welch Cancer Center at Sheridan Memorial Hospital	Sheridan	Wyoming	United States	82801

Sponsors and Collaborators

• Southwest Oncology Group
• 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

Investigators

• Study Chair: Michael J. Kraut, MD, Providence Hospital
• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Southwest Oncology Group
• ClinicalTrials.gov Identifier: NCT00062439
• Other Study ID Numbers: CDR0000304777; U10CA032102; S0220
• First Posted: Jun 6, 2003
• Last Update Posted: Nov 25, 2013
• Last Verified: Oct 1, 2013

• 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: Lung Neoplasms; Pancoast Syndrome; Docetaxel; Etoposide

Study Results

Participant Flow

Arm/Group Title	Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem
Arm/Group Description	Patients were given induction therapy consisting of concurrent cisplatin + etoposide + 45 Gy thoracic radiation given in 25 daily fractions, followed by thoracotomy, followed by consolidation chemotherapy consisting of three cycles of docetaxel.
Period Title: Induction Chemotherapy + Radiotherapy
STARTED	46
COMPLETED	38
NOT COMPLETED	8
Period Title: Induction Chemotherapy + Radiotherapy
STARTED	38
COMPLETED	29
NOT COMPLETED	9
Period Title: Induction Chemotherapy + Radiotherapy
STARTED	29
COMPLETED	22
NOT COMPLETED	7
Period Title: Induction Chemotherapy + Radiotherapy
STARTED	22
COMPLETED	20
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem
Arm/Group Description	Patients were given induction therapy consisting of concurrent cisplatin + etoposide + 45 Gy thoracic radiation given in 25 daily fractions, followed by thoracotomy, followed by consolidation chemotherapy consisting of three cycles of docetaxel.
Overall Participants	44
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	59
Sex: Female, Male (Count of Participants)
Female	12 27.3%
Male	32 72.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 2.3%
Asian	3 6.8%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	40 90.9%
More than one race	0 0%
Unknown or Not Reported	0 0%

Outcome Measures

1. Secondary Outcome

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.

Outcome Measure Data

Analysis Population Description

Eligible patients who received the study intervention.

Arm/Group Title	Induction Cisplatin/Etoposide + XRT	Surgery	Consolidation Docetaxel
Arm/Group Description
Measure Participants	44	29	22
Adult respiratory distress syndrome (ARDS)	0 0%	3 NaN	0 NaN
Allergic reaction/hypersensitivity	1 2.3%	0 NaN	0 NaN
Chylothorax	0 0%	2 NaN	0 NaN
Dehydration	2 4.5%	0 NaN	2 NaN
Diarrhea	1 2.3%	0 NaN	1 NaN
Dyspnea (shortness of breath)	0 0%	0 NaN	2 NaN
Esophagitis	1 2.3%	0 NaN	0 NaN
Fatigue (asthenia, lethargy, malaise)	2 4.5%	0 NaN	1 NaN
Febrile neutropenia	2 4.5%	0 NaN	0 NaN
Fistula, pulmonary/upper respiratory - Bronchus	0 0%	1 NaN	0 NaN
Fistula, pulmonary/upper respiratory - Lung	0 0%	1 NaN	0 NaN
Glucose, serum-high (hyperglycemia)	0 0%	1 NaN	1 NaN
Hemoglobin	3 6.8%	4 NaN	0 NaN
Hemorrhage/bleeding w/surgery, intra- or post-op	0 0%	1 NaN	0 NaN
Hypoxia	0 0%	3 NaN	1 NaN
Inf (clin/microbio) w/Gr 3-4 neuts - Blood	1 2.3%	0 NaN	0 NaN
Inf (clin/microbio) w/Gr 3-4 neuts - Bronchus	1 2.3%	0 NaN	0 NaN
Inf (clin/microbio) w/Gr 3-4 neuts - Lung	0 0%	1 NaN	1 NaN
Inf (clin/microbio) w/Gr 3-4 neuts - Wound	0 0%	1 NaN	0 NaN
Inf w/normal ANC or Gr 1-2 neutrophils - Lung	0 0%	2 NaN	0 NaN
Inf w/normal ANC or Gr 1-2 neutrophils - Meninges	0 0%	1 NaN	0 NaN
Inf w/normal ANC or Gr 1-2 neutrophils - Wound	0 0%	1 NaN	0 NaN
Infection with unknown ANC - Lung (pneumonia)	0 0%	1 NaN	0 NaN
Infection with unknown ANC - Wound	0 0%	1 NaN	0 NaN
Leak, cerebrospinal fluid (CSF)	0 0%	1 NaN	0 NaN
Leukocytes (total WBC)	11 25%	0 NaN	6 NaN
Lymphopenia	3 6.8%	0 NaN	2 NaN
Metabolic/Laboratory-Other (Specify)	1 2.3%	0 NaN	0 NaN
Mucositis/stomatitis (clinical exam) - Esophagus	1 2.3%	0 NaN	0 NaN
Nausea	1 2.3%	0 NaN	1 NaN
Neutrophils/granulocytes (ANC/AGC)	15 34.1%	0 NaN	8 NaN
Pain - Chest wall	0 0%	1 NaN	0 NaN
Pain - Extremity-limb	0 0%	1 NaN	0 NaN
Pain-Other (Specify)	0 0%	0 NaN	1 NaN
Platelets	0 0%	1 NaN	0 NaN
Pulmonary/Upper Respiratory-Other (Specify)	0 0%	1 NaN	0 NaN
SVT and nodal arrhythmia - Atrial fibrillation	0 0%	1 NaN	0 NaN
Sodium, serum-low (hyponatremia)	1 2.3%	0 NaN	0 NaN
Thrombosis/thrombus/embolism	1 2.3%	0 NaN	0 NaN
Ventricular arrhythmia - Ventricular fibrillation	0 0%	1 NaN	0 NaN
Vomiting	2 4.5%	0 NaN	1 NaN
Weight loss	0 0%	0 NaN	1 NaN

2. Primary Outcome

Title	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.
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

Outcome Measure Data

Analysis Population Description

Eligible patients who began the treatment regimen were included in the analysis.

Arm/Group Title	Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem
Arm/Group Description	Patients were given induction therapy consisting of concurrent cisplatin + etoposide + 45 Gy thoracic radiation given in 25 daily fractions, followed by thoracotomy, followed by consolidation chemotherapy consisting of three cycles of docetaxel.
Measure Participants	44
Number (95% Confidence Interval) [percentage of participants]	45 102.3%

3. Secondary Outcome

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.

Outcome Measure Data

Analysis Population Description

Eligible patients who began the treatment regimen were included in the analysis.

Arm/Group Title	Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem
Arm/Group Description	Patients were given induction therapy consisting of concurrent cisplatin + etoposide + 45 Gy thoracic radiation given in 25 daily fractions, followed by thoracotomy, followed by consolidation chemotherapy consisting of three cycles of docetaxel.
Measure Participants	44
Median (95% Confidence Interval) [years]	4

4. Secondary Outcome

Title	Progression-Free Survival at 3 Years
Description	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.
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.

Outcome Measure Data

Analysis Population Description

Eligible patients who began the treatment regimen were included in the analysis.

Arm/Group Title	Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem
Arm/Group Description	Patients were given induction therapy consisting of concurrent cisplatin + etoposide + 45 Gy thoracic radiation given in 25 daily fractions, followed by thoracotomy, followed by consolidation chemotherapy consisting of three cycles of docetaxel.
Measure Participants	44
Number (95% Confidence Interval) [percentage of patients]	56

5. Secondary Outcome

Title	Response
Description	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.
Time Frame	After completion of induction therapy.

Outcome Measure Data

Analysis Population Description

Eligible patients who began the treatment regimen and who had measurable disease (per RECIST) at baseline were included in the analysis of response.

Arm/Group Title	Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem
Arm/Group Description	Patients were given induction therapy consisting of concurrent cisplatin + etoposide + 45 Gy thoracic radiation given in 25 daily fractions, followed by thoracotomy, followed by consolidation chemotherapy consisting of three cycles of docetaxel.
Measure Participants	32
Number (95% Confidence Interval) [percentage of participants]	28 63.6%

Adverse Events

Time Frame	Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
Arm/Group Title	Induction Cisplatin/Etoposide + XRT		Surgery		Consolidation Docetaxel
Arm/Group Description
All Cause Mortality
	Induction Cisplatin/Etoposide + XRT		Surgery		Consolidation Docetaxel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Induction Cisplatin/Etoposide + XRT		Surgery		Consolidation Docetaxel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/44 (2.3%)		3/29 (10.3%)		0/22 (0%)
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Esophagus	1/44 (2.3%)		0/29 (0%)		0/22 (0%)
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Blood	1/44 (2.3%)		0/29 (0%)		0/22 (0%)
Inf w/normal ANC or Gr 1-2 neutrophils - Lung	0/44 (0%)		1/29 (3.4%)		0/22 (0%)
Infection with unknown ANC - Wound	0/44 (0%)		1/29 (3.4%)		0/22 (0%)
Investigations
Leukocytes (total WBC)	1/44 (2.3%)		0/29 (0%)		0/22 (0%)
Metabolism and nutrition disorders
Dehydration	1/44 (2.3%)		0/29 (0%)		0/22 (0%)
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome (ARDS)	0/44 (0%)		3/29 (10.3%)		0/22 (0%)
Other (Not Including Serious) Adverse Events
	Induction Cisplatin/Etoposide + XRT		Surgery		Consolidation Docetaxel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	43/44 (97.7%)		26/29 (89.7%)		21/22 (95.5%)
Blood and lymphatic system disorders
Hemoglobin	28/44 (63.6%)		16/29 (55.2%)		13/22 (59.1%)
Cardiac disorders
SVT and nodal arrhythmia - Atrial fibrillation	0/44 (0%)		3/29 (10.3%)		0/22 (0%)
SVT and nodal arrhythmia - Atrial flutter	0/44 (0%)		2/29 (6.9%)		0/22 (0%)
SVT and nodal arrhythmia - SVT arrhythmia NOS	0/44 (0%)		4/29 (13.8%)		0/22 (0%)
Gastrointestinal disorders
Constipation	17/44 (38.6%)		0/29 (0%)		5/22 (22.7%)
Diarrhea	9/44 (20.5%)		0/29 (0%)		5/22 (22.7%)
Dysphagia (difficulty swallowing)	12/44 (27.3%)		0/29 (0%)		2/22 (9.1%)
Esophagitis	10/44 (22.7%)		0/29 (0%)		0/22 (0%)
Gastrointestinal-Other (Specify)	4/44 (9.1%)		0/29 (0%)		3/22 (13.6%)
Mucositis/stomatitis (clinical exam) - Oral cavity	4/44 (9.1%)		0/29 (0%)		0/22 (0%)
Nausea	32/44 (72.7%)		0/29 (0%)		6/22 (27.3%)
Vomiting	17/44 (38.6%)		0/29 (0%)		4/22 (18.2%)
General disorders
Edema: head and neck	0/44 (0%)		0/29 (0%)		2/22 (9.1%)
Fatigue (asthenia, lethargy, malaise)	32/44 (72.7%)		3/29 (10.3%)		12/22 (54.5%)
Fever in absence of neutropenia, ANC lt1.0x10e9/L	3/44 (6.8%)		5/29 (17.2%)		4/22 (18.2%)
Pain-Other (Specify)	12/44 (27.3%)		0/29 (0%)		7/22 (31.8%)
Rigors/chills	5/44 (11.4%)		0/29 (0%)		2/22 (9.1%)
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Wound	0/44 (0%)		2/29 (6.9%)		0/22 (0%)
Inf w/normal ANC or Gr 1-2 neutrophils - Lung	0/44 (0%)		2/29 (6.9%)		0/22 (0%)
Inf w/normal ANC or Gr 1-2 neutrophils - Wound	0/44 (0%)		2/29 (6.9%)		0/22 (0%)
Injury, poisoning and procedural complications
Rash: dermatitis associated w/radiation	16/44 (36.4%)		0/29 (0%)		0/22 (0%)
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)	5/44 (11.4%)		0/29 (0%)		0/22 (0%)
AST, SGOT	4/44 (9.1%)		0/29 (0%)		0/22 (0%)
Alkaline phosphatase	5/44 (11.4%)		0/29 (0%)		2/22 (9.1%)
Creatinine	0/44 (0%)		6/29 (20.7%)		0/22 (0%)
Leukocytes (total WBC)	24/44 (54.5%)		3/29 (10.3%)		10/22 (45.5%)
Lymphopenia	4/44 (9.1%)		0/29 (0%)		3/22 (13.6%)
Neutrophils/granulocytes (ANC/AGC)	19/44 (43.2%)		0/29 (0%)		10/22 (45.5%)
Platelets	14/44 (31.8%)		9/29 (31%)		0/22 (0%)
Weight loss	11/44 (25%)		3/29 (10.3%)		5/22 (22.7%)
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)	7/44 (15.9%)		0/29 (0%)		2/22 (9.1%)
Anorexia	5/44 (11.4%)		2/29 (6.9%)		0/22 (0%)
Calcium, serum-low (hypocalcemia)	0/44 (0%)		3/29 (10.3%)		2/22 (9.1%)
Dehydration	7/44 (15.9%)		0/29 (0%)		3/22 (13.6%)
Glucose, serum-high (hyperglycemia)	4/44 (9.1%)		5/29 (17.2%)		4/22 (18.2%)
Potassium, serum-high (hyperkalemia)	0/44 (0%)		2/29 (6.9%)		0/22 (0%)
Potassium, serum-low (hypokalemia)	0/44 (0%)		2/29 (6.9%)		0/22 (0%)
Sodium, serum-low (hyponatremia)	7/44 (15.9%)		3/29 (10.3%)		0/22 (0%)
Musculoskeletal and connective tissue disorders
Pain - Chest wall	0/44 (0%)		3/29 (10.3%)		2/22 (9.1%)
Pain - Extremity-limb	0/44 (0%)		2/29 (6.9%)		0/22 (0%)
Pain - Joint	3/44 (6.8%)		0/29 (0%)		0/22 (0%)
Pain - Muscle	4/44 (9.1%)		0/29 (0%)		5/22 (22.7%)
Nervous system disorders
Neuropathy: motor	0/44 (0%)		2/29 (6.9%)		0/22 (0%)
Neuropathy: sensory	9/44 (20.5%)		2/29 (6.9%)		9/22 (40.9%)
Taste alteration (dysgeusia)	12/44 (27.3%)		0/29 (0%)		3/22 (13.6%)
Psychiatric disorders
Mood alteration - anxiety	0/44 (0%)		2/29 (6.9%)		0/22 (0%)
Mood alteration - depression	3/44 (6.8%)		2/29 (6.9%)		2/22 (9.1%)
Respiratory, thoracic and mediastinal disorders
Chylothorax	0/44 (0%)		2/29 (6.9%)		0/22 (0%)
Cough	3/44 (6.8%)		0/29 (0%)		7/22 (31.8%)
Dyspnea (shortness of breath)	0/44 (0%)		3/29 (10.3%)		4/22 (18.2%)
Hypoxia	0/44 (0%)		3/29 (10.3%)		0/22 (0%)
Pleural effusion (non-malignant)	0/44 (0%)		3/29 (10.3%)		2/22 (9.1%)
Pneumothorax	0/44 (0%)		6/29 (20.7%)		0/22 (0%)
Pulmonary/Upper Respiratory-Other (Specify)	0/44 (0%)		3/29 (10.3%)		0/22 (0%)
Voice changes/dysarthria	3/44 (6.8%)		0/29 (0%)		0/22 (0%)
Skin and subcutaneous tissue disorders
Hair loss/Alopecia (scalp or body)	11/44 (25%)		0/29 (0%)		3/22 (13.6%)
Rash: hand-foot skin reaction	0/44 (0%)		0/29 (0%)		2/22 (9.1%)
Vascular disorders
Hypotension	5/44 (11.4%)		2/29 (6.9%)		2/22 (9.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.