Chemotherapy and Radiation Therapy With or Without Epoetin Alfa in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy 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. Epoetin alfa may stimulate red blood cell production and prevent or treat anemia in patients who are undergoing radiation therapy and chemotherapy. It is not yet known if chemotherapy combined with radiation therapy is more effective with or without epoetin alfa in treating non-small cell lung cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of chemotherapy combined with radiation therapy with or without epoetin alfa in treating patients who have stage IIIA or stage IIIB non-small cell lung cancer.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 2 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Sep 9, 2021 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Wake Forest University Health Sciences
- Interventions being studied
- Biological: epoetin alfa; Drug: carboplatin; Drug: paclitaxel; Radiation: radiation therapy
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed stage IIIA or IIIB non-small cell lung cancer (NSCLC)
- Squamous cell carcinoma
- Adenocarcinoma (including bronchoalveolar cell)
- Large cell anaplastic carcinoma (including giant and clear cell carcinomas) PATIENT CHARACTERISTICS: Age:
- 18 and over Performance status:
- Karnofsky 60-100% Life expectancy:
- Not specified Hematopoietic:
- Granulocyte count at least 1,500/mm3
- Platelet count at least 100,000/mm3
- Hemoglobin 11.0-15 g/dL
- If hemoglobin is 11.0-11.9 g/dL then the following lab values are required:
- Iron greater than 60 mcg/mL
- Transferrin saturation greater than 20%
- Ferritin at least 100 mg/mL
- Iron binding capacity less than 400 mcg/dL
- RBC folate normal
- B12 normal Hepatic:
- Bilirubin less than 1.5 mg/dL
- AST less than 2 times upper limit of normal Renal:
- Creatinine clearance at least 20 mL/min Cardiovascular:
- No uncontrolled hypertension Pulmonary:
- FEV1 at least 0.8 L Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No known hypersensitivity to mammalian cell-derived products or human albumin
- No other concurrent or prior malignancy within the past 2 years except non- melanoma skin cancers PRIOR CONCURRENT THERAPY: Biologic therapy:
- At least 30 days since prior transfusion
- No prior epoetin alfa or experimental forms of epoetin alfa Chemotherapy:
- No prior chemotherapy for NSCLC Endocrine therapy:
- Not specified Radiotherapy:
- No prior radiotherapy for NSCLC Surgery:
- At least 2 weeks since prior thoracotomy Other:
- No concurrent therapy for iron, folate, or B12 deficiency
- No other concurrent anti-cancer therapy
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 9, 2021. Always confirm current availability with the study team.