Clinical trial · Interventional
Cisplatin and Docetaxel With or Without Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Newly Diagnosed Stage III Non-Small Cell Lung Cancer
Phase III Randomized Trial of Preoperative Chemotherapy Versus Preoperative Concurrent Chemotherapy and Thoracic Radiotherapy Followed by Surgical Resection and Consolidation Chemotherapy in Favorable Prognosis Patients With Stage IIIA (N2) Non-Small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): This study terminated early due to low accrual.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| cisplatin | Drug | Cisplatin | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| docetaxel | Drug | Docetaxel | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| pegfilgrastim | Biological | Pegfilgrastim | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Induction chemotherapy, surgery, consolidation chemotherapy
- description
- Induction/surgery/consolidation
- interventionNames
- Biological: filgrastim
- Biological: pegfilgrastim
- Drug: cisplatin
- Drug: docetaxel
- Procedure: adjuvant therapy
- Procedure: conventional surgery
- Procedure: neoadjuvant therapy
- type
- OTHER
- label
- Chemotherapy and radiation, surgery, consolidation ch
- description
- Induction/radiation/surgery/cosolidation
- interventionNames
- Biological: filgrastim
- Biological: pegfilgrastim
- Drug: cisplatin
- Drug: docetaxel
- Procedure: adjuvant therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed primary non-small cell lung cancer (NSCLC)\*, including any of the following cellular types:
* Adenocarcinoma
* Squamous cell carcinoma
* Large cell carcinoma
* Non-lobar and non-diffuse bronchoalveolar cell carcinoma
* NSCLC not otherwise specified NOTE: \*Diagnosed within the past 3 months; diagnosis by mediastinal nodal biopsy or needle aspiration allowed provided a distinct lung primary (separate from the nodes) is clearly evident on CT scan
* Stage IIIA disease
* T1-T3 disease
* If pleural effusion is present, must meet ≥ 1 of the following criteria to exclude T4 disease:
* Pleural effusion cytologically negative by thoracentesis
* Documented absence of pleural metastases and pleural effusion cytologically negative by thoracoscopy (for patients with pleural effusion on CT scan \[but not on chest x-ray\] that is deemed too small to tap safely under either CT scan or ultrasound guidance)
* 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
* N2 nodes must be separate from primary tumor by CT scan or surgical exploration AND maximum diameter ≤ 3.0 cm
* Mediastinoscopy OR other means of mediastinal lymph node biopsy required (regardless of the primary tumor site) for patients with subcarinal lymphadenopathy by size criteria or by positron emission tomography (PET) scan
* If the lymph nodes in the contralateral mediastinum and neck are visible by contrast CT scan of the chest AND are ≥ 1.0 cm OR if contralateral involvement is suggested by PET scan, lymph nodes must be confirmed negative by one of the above diagnostic procedures AND N3 status must be confirmed negative by histology or cytology
* No palpable lymph nodes in the supraclavicular areas or higher in the neck unless proven benign by excisional biopsy
* A nodal biopsy or needle aspiration may be omitted provided all of the following criteria are true:
* Paralyzed left true vocal cord by bronchoscopy or indirect laryngoscopy
* Nodes visible in the aortopulmonary window (level 5) region on CT scan
* Distinct primary tumor (separate from the nodes) is visible by CT scan
* No evidence of subcarinal nodal involvement by CT scan NOTE: \*\*PET scan positivity is not sufficient to establish N2 nodal status
* Measurable disease by chest x-ray and/or contrast-enhanced CT scan
* Candidate for surgery
* Resectable disease
* No distant metastases, including other ipsilateral or contralateral parenchymal lesions or liver or adrenal metastases, by history or physical examination, fludeoxyglucose F 18 PET scan, MRI or CT scan of the brain, chest x-ray and/or CT scan of the lungs and upper abdomen
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Zubrod 0-1
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 1,800/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 10.0 g/dL (transfusion or other intervention allowed)
Hepatic
* ALT and AST ≤ 2.5 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 2.5 times ULN
* Bilirubin ≤ 1.5 times ULN
* No hepatic insufficiency resulting in clinical jaundice or coagulation defects
Renal
* Creatinine clearance ≥ 60 mL/min
Cardiovascular
* No unstable angina or congestive heart failure requiring hospitalization within the past 6 months
* No transmural myocardial infarction within the past 6 months
Pulmonary
* FEV\_1 ≥ 2.0 L OR
* Predicted post-resection FEV\_1 ≥ 0.8 L
* DLCO ≥ 50% of predicted
* No chronic obstructive pulmonary disease exacerbation
* No other respiratory illness requiring hospitalization or that would preclude study therapy
Immunologic
* No AIDS
* No prior allergic reaction to the study drugs
* No history of severe hypersensitivity to other drugs formulated with polysorbate 80
* No acute bacterial or fungal infection requiring IV antibiotics
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No unintentional weight loss \> 5% of body weight within the past 6 months
* No pre-existing peripheral neuropathy ≥ grade 2
* No other invasive malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the breast, oral cavity, or cervix
* No other severe active comorbidity
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior biological agent for this cancer
* No concurrent filgrastim (G-CSF), sargramostim (GM-CSF), or pegfilgrastim during study induction therapy (for patients randomized to the chemoradiotherapy arm)
Chemotherapy
* No prior systemic chemotherapy for this cancer
* Prior chemotherapy for a different cancer allowed
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy to the region of this cancer that would result in overlap of radiotherapy fields
* No routine post-operative radiotherapy
* No concurrent intensity modulated radiotherapy
Surgery
* See Disease Characteristics
Other
* No prior gefitinib for this cancer
* No concurrent amifostineReferences
Publications (0)
Data not yet available