A Phase 3 interventional study of filgrastim and pegfilgrastim in Lung Cancer, sponsored by Radiation Therapy Oncology Group. Terminated at 76 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-28.
Sponsored by Radiation Therapy Oncology Group · Phase 3, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Cisplatin and docetaxel may make tumor cells more sensitive to radiation therapy. Giving more than one drug (combination chemotherapy) together with radiation therapy before surgery may shrink the tumor so it can be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving cisplatin and docetaxel together with radiation therapy is more effective than giving cisplatin together with docetaxel in treating non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying cisplatin, docetaxel, and radiation therapy to see how well they work compared to cisplatin and docetaxel in treating patients who are undergoing surgery for newly diagnosed stage III non-small cell lung cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to T stage (T1 vs T2-3), number of involved mediastinal lymph nodes (1 vs 2 or more vs not evaluable), and nodal micrometastases vs clinically involved nodes (mN2 vs cN2).
Induction therapy: Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed at baseline, within 2 weeks after completion of induction therapy, and then at 6 and 12 months after surgery.
After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 574 patients will be accrued for this study within 4 years.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 19 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Radiation Therapy Oncology Group is the lead sponsor of 154 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed primary non-small cell lung cancer (NSCLC)*, including any of the following cellular types:
Stage IIIA disease
T1-T3 disease
If pleural effusion is present, must meet ≥ 1 of the following criteria to exclude T4 disease:
Confirmed positive ipsilateral mediastinal lymph node(s) (N2 disease)**, with or without positive ipsilateral hilar nodes, by mediastinoscopy, mediastinotomy, endoscopic ultrasound-guided transesophageal biopsy, thoracotomy, video-assisted thoracoscopy, Wang needles, or fine needle aspiration under bronchoscopic or CT guidance
A nodal biopsy or needle aspiration may be omitted provided all of the following criteria are true:
Candidate for surgery
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
No prior systemic chemotherapy for this cancer
Endocrine therapy
Radiotherapy
Surgery
Other
Induction/surgery/consolidation
Biological: filgrastim · Biological: pegfilgrastim · Drug: cisplatin · Drug: docetaxel · Procedure: adjuvant therapy · Procedure: conventional surgery · Procedure: neoadjuvant therapy
Induction/radiation/surgery/cosolidation
Biological: filgrastim · Biological: pegfilgrastim · Drug: cisplatin · Drug: docetaxel · Procedure: adjuvant therapy · Procedure: conventional surgery · Procedure: neoadjuvant therapy · Radiation: radiation therapy
Consolidation chemotherapy
Consolidation chemotherapy
Comparison of Overall Survival
Time frame: Date of death or date of last follow-up
| Milestone | Preoperative Cisplatin/Docetaxel | Preoperative Radiotherapy and Cisplatin/Docetaxel |
|---|---|---|
| Started | 10 | 9 |
| Completed | 3 | 5 |
| Not completed | 7 | 4 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Physician decision | 0 | 1 |
| Withdrew: Toxicity | 3 | 0 |
| Withdrew: Ineligible | 1 | 2 |
| Withdrew: Unknown - lost to follow-up | 2 | 1 |
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Preoperative Cisplatin/Docetaxel | — | 5/9 (55.6%) | 7/9 (77.8%) |
| Preoperative Radiotherapy and Cisplatin/Docetaxel | — | 4/7 (57.1%) | 7/7 (100%) |
| Event | Preoperative Cisplatin/Docetaxel | Preoperative Radiotherapy and Cisplatin/Docetaxel |
|---|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 4/9 | 0/7 |
| Neutrophil count decreasedInvestigations | 4/9 | 1/7 |
| White blood cell decreasedInvestigations | 3/9 | 0/7 |
| Atrial flutterCardiac disorders | 0/9 | 1/7 |
| Colonic hemorrhageGastrointestinal disorders | 0/9 | 1/7 |
| Rectal hemorrhageGastrointestinal disorders | 0/9 | 1/7 |
| Wound dehiscenceInjury, poisoning and procedural complications | 0/9 | 1/7 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 0/9 | 1/7 |
| HypertensionVascular disorders | 0/9 | 1/7 |
| HypotensionVascular disorders | 1/9 | 1/7 |
| Event | Preoperative Cisplatin/Docetaxel | Preoperative Radiotherapy and Cisplatin/Docetaxel |
|---|---|---|
| NauseaGastrointestinal disorders | 5/9 | 6/7 |
| FatigueGeneral disorders | 6/9 | 6/7 |
| AnorexiaMetabolism and nutrition disorders | 3/9 | 5/7 |
| AnemiaBlood and lymphatic system disorders | 6/9 | 4/7 |
| EsophagitisGastrointestinal disorders | 0/9 | 4/7 |
| VomitingGastrointestinal disorders | 2/9 | 4/7 |
| HyponatremiaMetabolism and nutrition disorders | 4/9 | 4/7 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 3/9 | 4/7 |
| DiarrheaGastrointestinal disorders | 5/9 | 1/7 |
| Aspartate aminotransferase increasedInvestigations | 4/9 | 1/7 |
| Age Continuous(years) | Preoperative Cisplatin/Docetaxel | Preoperative Radiotherapy and Cisplatin/Docetaxel | Total |
|---|---|---|---|
| Median | 66 (43 to 77) | 57 (45 to 72) | 63 (43 to 77) |
| Sex: Female, Male(Participants) | Preoperative Cisplatin/Docetaxel | Preoperative Radiotherapy and Cisplatin/Docetaxel | Total |
|---|---|---|---|
| Female | 2 | 4 | 6 |
| Male | 6 | 3 | 9 |
This study is terminated, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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