Lung Cancer
Conditions
Keywords
stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
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.
Interventions
DRUGcisplatin
During induction:50 mg/m2,IV on Days 1, 8, 29 & 36. In any appropriate vehicle over 60 minutes
DRUGdocetaxel
During consolidation: 75 mg/m2 IV on Day 1, every 21 days for 3 cycles over 60 minutes
DRUGetoposide
During induction: 50 mg/m2, IV on Days 1 - 5 Days 29 - 33. In 250 ml of NS over 60 minutes.
PROCEDUREconventional 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.
RADIATIONradiation 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.
Sponsors
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
SWOG Cancer Research Network
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem 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. | 44 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Consolidation Chemotherapy | Adverse Event | 2 |
| Induction Chemotherapy + Radiotherapy | Adverse Event | 3 |
| Induction Chemotherapy + Radiotherapy | Ineligible | 1 |
| Induction Chemotherapy + Radiotherapy | Lack of Efficacy | 3 |
| Induction Chemotherapy + Radiotherapy | Refused protocol treatment | 1 |
| Post Chemoradiation Assessment | Death | 1 |
| Post Chemoradiation Assessment | Disease progression | 2 |
| Post Chemoradiation Assessment | Not eligible to continue to surgery | 4 |
| Post Chemoradiation Assessment | Physician Decision | 1 |
| Post Chemoradiation Assessment | Withdrawal by Subject | 1 |
| Surgery | Adverse Event | 2 |
| Surgery | Death | 1 |
| Surgery | Physician Decision | 4 |
Baseline characteristics
| Characteristic | Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem |
|---|---|
| Age Continuous | 59 years |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 40 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 43 / 44 | 26 / 29 | 21 / 22 |
| serious Total, serious adverse events | 1 / 44 | 3 / 29 | 0 / 22 |
Outcome results
Primary
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.
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
Population: Eligible patients who began the treatment regimen were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Induction Cisplatin/Etoposide + XRT | 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. | 45 percentage of participants |
Secondary
Adverse Events
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.
Population: Eligible patients who received the study intervention.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Induction Cisplatin/Etoposide + XRT | Adverse Events | Ventricular arrhythmia - Ventricular fibrillation | 0 Participants |
| Induction Cisplatin/Etoposide + XRT | Adverse Events | Lymphopenia | 3 Participants |
| Induction Cisplatin/Etoposide + XRT | Adverse Events | Glucose, serum-high (hyperglycemia) | 0 Participants |
| Induction Cisplatin/Etoposide + XRT | Adverse Events | Pain-Other (Specify) | 0 Participants |
| Induction Cisplatin/Etoposide + XRT | Adverse Events | Leukocytes (total WBC) | 11 Participants |
| Induction Cisplatin/Etoposide + XRT | Adverse Events | Hemoglobin | 3 Participants |
| Induction Cisplatin/Etoposide + XRT | Adverse Events | Chylothorax | 0 Participants |
| Induction Cisplatin/Etoposide + XRT | Adverse Events | Leak, cerebrospinal fluid (CSF) | 0 Participants |
| Induction Cisplatin/Etoposide + XRT | Adverse Events | Hemorrhage/bleeding w/surgery, intra- or post-op | 0 Participants |
| Induction Cisplatin/Etoposide + XRT | Adverse Events | Thrombosis/thrombus/embolism | 1 Participants |
| Induction Cisplatin/Etoposide + XRT | Adverse Events | Infection with unknown ANC - Wound | 0 Participants |
| Induction Cisplatin/Etoposide + XRT | Adverse Events | Pain - Extremity-limb | 0 Participants |
| Induction Cisplatin/Etoposide + XRT | Adverse Events | Infection with unknown ANC - Lung (pneumonia) | 0 Participants |
| Induction Cisplatin/Etoposide + XRT | Adverse Events | Inf (clin/microbio) w/Gr 3-4 neuts - Blood | 1 Participants |
| Induction Cisplatin/Etoposide + XRT | Adverse Events | Dehydration | 2 Participants |
| Induction Cisplatin/Etoposide + XRT | Adverse Events | Inf w/normal ANC or Gr 1-2 neutrophils - Wound | 0 Participants |
| Induction Cisplatin/Etoposide + XRT | Adverse Events | Inf (clin/microbio) w/Gr 3-4 neuts - Bronchus | 1 Participants |
| Induction Cisplatin/Etoposide + XRT | Adverse Events | SVT and nodal arrhythmia - Atrial fibrillation | 0 Participants |
| Induction Cisplatin/Etoposide + XRT | Adverse Events | Inf w/normal ANC or Gr 1-2 neutrophils - Meninges | 0 Participants |
| Induction Cisplatin/Etoposide + XRT | Adverse Events | Inf (clin/microbio) w/Gr 3-4 neuts - Lung | 0 Participants |
| Induction Cisplatin/Etoposide + XRT | Adverse Events | Pain - Chest wall | 0 Participants |
| Induction Cisplatin/Etoposide + XRT | Adverse Events | Inf w/normal ANC or Gr 1-2 neutrophils - Lung | 0 Participants |
| Induction Cisplatin/Etoposide + XRT | Adverse Events | Inf (clin/microbio) w/Gr 3-4 neuts - Wound | 0 Participants |
| Induction Cisplatin/Etoposide + XRT | Adverse Events | Diarrhea | 1 Participants |
| Induction Cisplatin/Etoposide + XRT | Adverse Events | Weight loss | 0 Participants |
| Induction Cisplatin/Etoposide + XRT | Adverse Events | Neutrophils/granulocytes (ANC/AGC) | 15 Participants |
| Induction Cisplatin/Etoposide + XRT | Adverse Events | Dyspnea (shortness of breath) | 0 Participants |
| Induction Cisplatin/Etoposide + XRT | Adverse Events | Pulmonary/Upper Respiratory-Other (Specify) | 0 Participants |
| Induction Cisplatin/Etoposide + XRT | Adverse Events | Nausea | 1 Participants |
| Induction Cisplatin/Etoposide + XRT | Adverse Events | Esophagitis | 1 Participants |
| Induction Cisplatin/Etoposide + XRT | Adverse Events | Adult respiratory distress syndrome (ARDS) | 0 Participants |
| Induction Cisplatin/Etoposide + XRT | Adverse Events | Hypoxia | 0 Participants |
| Induction Cisplatin/Etoposide + XRT | Adverse Events | Fatigue (asthenia, lethargy, malaise) | 2 Participants |
| Induction Cisplatin/Etoposide + XRT | Adverse Events | Vomiting | 2 Participants |
| Induction Cisplatin/Etoposide + XRT | Adverse Events | Mucositis/stomatitis (clinical exam) - Esophagus | 1 Participants |
| Induction Cisplatin/Etoposide + XRT | Adverse Events | Febrile neutropenia | 2 Participants |
| Induction Cisplatin/Etoposide + XRT | Adverse Events | Platelets | 0 Participants |
| Induction Cisplatin/Etoposide + XRT | Adverse Events | Sodium, serum-low (hyponatremia) | 1 Participants |
| Induction Cisplatin/Etoposide + XRT | Adverse Events | Fistula, pulmonary/upper respiratory - Bronchus | 0 Participants |
| Induction Cisplatin/Etoposide + XRT | Adverse Events | Allergic reaction/hypersensitivity | 1 Participants |
| Induction Cisplatin/Etoposide + XRT | Adverse Events | Metabolic/Laboratory-Other (Specify) | 1 Participants |
| Induction Cisplatin/Etoposide + XRT | Adverse Events | Fistula, pulmonary/upper respiratory - Lung | 0 Participants |
| Surgery | Adverse Events | Mucositis/stomatitis (clinical exam) - Esophagus | 0 Participants |
| Surgery | Adverse Events | Sodium, serum-low (hyponatremia) | 0 Participants |
| Surgery | Adverse Events | Thrombosis/thrombus/embolism | 0 Participants |
| Surgery | Adverse Events | Inf w/normal ANC or Gr 1-2 neutrophils - Lung | 2 Participants |
| Surgery | Adverse Events | SVT and nodal arrhythmia - Atrial fibrillation | 1 Participants |
| Surgery | Adverse Events | Adult respiratory distress syndrome (ARDS) | 3 Participants |
| Surgery | Adverse Events | Allergic reaction/hypersensitivity | 0 Participants |
| Surgery | Adverse Events | Chylothorax | 2 Participants |
| Surgery | Adverse Events | Dehydration | 0 Participants |
| Surgery | Adverse Events | Diarrhea | 0 Participants |
| Surgery | Adverse Events | Dyspnea (shortness of breath) | 0 Participants |
| Surgery | Adverse Events | Esophagitis | 0 Participants |
| Surgery | Adverse Events | Fatigue (asthenia, lethargy, malaise) | 0 Participants |
| Surgery | Adverse Events | Febrile neutropenia | 0 Participants |
| Surgery | Adverse Events | Fistula, pulmonary/upper respiratory - Bronchus | 1 Participants |
| Surgery | Adverse Events | Fistula, pulmonary/upper respiratory - Lung | 1 Participants |
| Surgery | Adverse Events | Glucose, serum-high (hyperglycemia) | 1 Participants |
| Surgery | Adverse Events | Hemoglobin | 4 Participants |
| Surgery | Adverse Events | Hemorrhage/bleeding w/surgery, intra- or post-op | 1 Participants |
| Surgery | Adverse Events | Hypoxia | 3 Participants |
| Surgery | Adverse Events | Inf (clin/microbio) w/Gr 3-4 neuts - Blood | 0 Participants |
| Surgery | Adverse Events | Inf (clin/microbio) w/Gr 3-4 neuts - Bronchus | 0 Participants |
| Surgery | Adverse Events | Inf (clin/microbio) w/Gr 3-4 neuts - Lung | 1 Participants |
| Surgery | Adverse Events | Inf (clin/microbio) w/Gr 3-4 neuts - Wound | 1 Participants |
| Surgery | Adverse Events | Inf w/normal ANC or Gr 1-2 neutrophils - Meninges | 1 Participants |
| Surgery | Adverse Events | Inf w/normal ANC or Gr 1-2 neutrophils - Wound | 1 Participants |
| Surgery | Adverse Events | Infection with unknown ANC - Lung (pneumonia) | 1 Participants |
| Surgery | Adverse Events | Infection with unknown ANC - Wound | 1 Participants |
| Surgery | Adverse Events | Leak, cerebrospinal fluid (CSF) | 1 Participants |
| Surgery | Adverse Events | Leukocytes (total WBC) | 0 Participants |
| Surgery | Adverse Events | Lymphopenia | 0 Participants |
| Surgery | Adverse Events | Metabolic/Laboratory-Other (Specify) | 0 Participants |
| Surgery | Adverse Events | Nausea | 0 Participants |
| Surgery | Adverse Events | Neutrophils/granulocytes (ANC/AGC) | 0 Participants |
| Surgery | Adverse Events | Pain - Chest wall | 1 Participants |
| Surgery | Adverse Events | Pain - Extremity-limb | 1 Participants |
| Surgery | Adverse Events | Pain-Other (Specify) | 0 Participants |
| Surgery | Adverse Events | Platelets | 1 Participants |
| Surgery | Adverse Events | Pulmonary/Upper Respiratory-Other (Specify) | 1 Participants |
| Surgery | Adverse Events | Ventricular arrhythmia - Ventricular fibrillation | 1 Participants |
| Surgery | Adverse Events | Vomiting | 0 Participants |
| Surgery | Adverse Events | Weight loss | 0 Participants |
| Consolidation Docetaxel | Adverse Events | Glucose, serum-high (hyperglycemia) | 1 Participants |
| Consolidation Docetaxel | Adverse Events | Weight loss | 1 Participants |
| Consolidation Docetaxel | Adverse Events | Leukocytes (total WBC) | 6 Participants |
| Consolidation Docetaxel | Adverse Events | Fistula, pulmonary/upper respiratory - Lung | 0 Participants |
| Consolidation Docetaxel | Adverse Events | Platelets | 0 Participants |
| Consolidation Docetaxel | Adverse Events | Lymphopenia | 2 Participants |
| Consolidation Docetaxel | Adverse Events | Fistula, pulmonary/upper respiratory - Bronchus | 0 Participants |
| Consolidation Docetaxel | Adverse Events | SVT and nodal arrhythmia - Atrial fibrillation | 0 Participants |
| Consolidation Docetaxel | Adverse Events | Febrile neutropenia | 0 Participants |
| Consolidation Docetaxel | Adverse Events | Metabolic/Laboratory-Other (Specify) | 0 Participants |
| Consolidation Docetaxel | Adverse Events | Fatigue (asthenia, lethargy, malaise) | 1 Participants |
| Consolidation Docetaxel | Adverse Events | Esophagitis | 0 Participants |
| Consolidation Docetaxel | Adverse Events | Mucositis/stomatitis (clinical exam) - Esophagus | 0 Participants |
| Consolidation Docetaxel | Adverse Events | Dyspnea (shortness of breath) | 2 Participants |
| Consolidation Docetaxel | Adverse Events | Vomiting | 1 Participants |
| Consolidation Docetaxel | Adverse Events | Nausea | 1 Participants |
| Consolidation Docetaxel | Adverse Events | Diarrhea | 1 Participants |
| Consolidation Docetaxel | Adverse Events | Pulmonary/Upper Respiratory-Other (Specify) | 0 Participants |
| Consolidation Docetaxel | Adverse Events | Neutrophils/granulocytes (ANC/AGC) | 8 Participants |
| Consolidation Docetaxel | Adverse Events | Dehydration | 2 Participants |
| Consolidation Docetaxel | Adverse Events | Sodium, serum-low (hyponatremia) | 0 Participants |
| Consolidation Docetaxel | Adverse Events | Pain - Chest wall | 0 Participants |
| Consolidation Docetaxel | Adverse Events | Chylothorax | 0 Participants |
| Consolidation Docetaxel | Adverse Events | Ventricular arrhythmia - Ventricular fibrillation | 0 Participants |
| Consolidation Docetaxel | Adverse Events | Inf (clin/microbio) w/Gr 3-4 neuts - Wound | 0 Participants |
| Consolidation Docetaxel | Adverse Events | Inf (clin/microbio) w/Gr 3-4 neuts - Lung | 1 Participants |
| Consolidation Docetaxel | Adverse Events | Inf w/normal ANC or Gr 1-2 neutrophils - Lung | 0 Participants |
| Consolidation Docetaxel | Adverse Events | Inf (clin/microbio) w/Gr 3-4 neuts - Bronchus | 0 Participants |
| Consolidation Docetaxel | Adverse Events | Pain - Extremity-limb | 0 Participants |
| Consolidation Docetaxel | Adverse Events | Inf w/normal ANC or Gr 1-2 neutrophils - Meninges | 0 Participants |
| Consolidation Docetaxel | Adverse Events | Inf (clin/microbio) w/Gr 3-4 neuts - Blood | 0 Participants |
| Consolidation Docetaxel | Adverse Events | Allergic reaction/hypersensitivity | 0 Participants |
| Consolidation Docetaxel | Adverse Events | Inf w/normal ANC or Gr 1-2 neutrophils - Wound | 0 Participants |
| Consolidation Docetaxel | Adverse Events | Hypoxia | 1 Participants |
| Consolidation Docetaxel | Adverse Events | Thrombosis/thrombus/embolism | 0 Participants |
| Consolidation Docetaxel | Adverse Events | Infection with unknown ANC - Lung (pneumonia) | 0 Participants |
| Consolidation Docetaxel | Adverse Events | Hemorrhage/bleeding w/surgery, intra- or post-op | 0 Participants |
| Consolidation Docetaxel | Adverse Events | Pain-Other (Specify) | 1 Participants |
| Consolidation Docetaxel | Adverse Events | Infection with unknown ANC - Wound | 0 Participants |
| Consolidation Docetaxel | Adverse Events | Hemoglobin | 0 Participants |
| Consolidation Docetaxel | Adverse Events | Adult respiratory distress syndrome (ARDS) | 0 Participants |
| Consolidation Docetaxel | Adverse Events | Leak, cerebrospinal fluid (CSF) | 0 Participants |
Secondary
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.
Time frame: daily for 12 weeks then every 3 weeks for 12 weeks, then every 6 months thereafter.
Population: Eligible patients who began the treatment regimen were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Induction Cisplatin/Etoposide + XRT | Overall Survival | 4 years |
Secondary
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.
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.
Population: Eligible patients who began the treatment regimen were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Induction Cisplatin/Etoposide + XRT | Progression-Free Survival at 3 Years | 56 percentage of patients |
Secondary
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.
Time frame: After completion of induction therapy.
Population: Eligible patients who began the treatment regimen and who had measurable disease (per RECIST) at baseline were included in the analysis of response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Induction Cisplatin/Etoposide + XRT | Response | 28 percentage of participants |