Clinical trial · Interventional
Chemotherapy Plus Radiation Therapy With or Without Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer
A Phase III Comparison Between Concurrent Chemotherapy Plus Radiotherapy and Concurrent Chemotherapy Plus Radiotherapy Followed by Surgical Resection for 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
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet known if chemotherapy plus radiation therapy is more effective with or without surgery for lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combining cisplatin, etoposide, and radiation therapy with or without surgery in treating patients who have stage IIIA 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 (4)
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- RT + chemotherapy followed by surgery + chemotherapy
- description
- Induction radiation therapy (RT) + concurrent induction chemotherapy followed by surgery and additional chemotherapy
- interventionNames
- Drug: cisplatin
- Drug: etoposide
- Procedure: conventional surgery
- Radiation: radiation therapy
- type
- ACTIVE_COMPARATOR
- label
- RT + chemotherapy followed by chemotherapy + RT
- description
- Induction RT + concurrent induction chemotherapy followed by additional chemotherapy + RT
- interventionNames
- Drug: cisplatin
- Drug: etoposide
- Radiation: radiation therapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically proven newly diagnosed, stage IIIA (T1-3, N2) non-small cell lung cancer
* Eligible subtypes:
* Adenocarcinoma
* Large cell carcinoma
* Squamous cell carcinoma
* Nonlobar and nondiffuse bronchoalveolar cell carcinoma
* Measurable or evaluable disease on chest x-ray and/or contrast CT scan
* Contrast thoracic CT required to complete staging
* Single primary bronchogenic tumor (no more than 1 parenchymal lung lesion)
* Pleural effusions allowed if 1 of the following conditions is met:
* Negative cytology on thoracentesis if effusions present before mediastinoscopy or exploratory thoracotomy
* Effusion seen on CT scan but not on chest x-ray and deemed too small to tap under CT or ultrasound guidance
* Positive ipsilateral mediastinal node(s) with or without positive ipsilateral hilar nodes
* Mediastinal nodes separate from primary lesion on CT scan or surgical exploration
* Histologic or cytologic proof of N2 disease by thoracotomy, mediastinoscopy, mediastinotomy, Chamberlain procedure, Wang needle, or fine needle aspiration under bronchoscopic or CT guidance
* Nodal biopsy or aspiration waived if all of the following conditions are met:
* Paralyzed left true vocal cord documented by bronchoscopy or indirect laryngoscopy
* Nodes visible in Level 5 region on CT scan
* Distinct primary lesion separate from nodes on CT scan
* All mediastinal nodal involvement mapped (positive or negative)
* No positive nodes in contralateral mediastinum (supraclavicular areas and higher) and neck
* Mediastinoscopy, mediastinotomy, Chamberlain procedure, or thoracotomy required for nodes larger than 1 cm on contrast CT scan
* Surgery waived if nodes negative or no larger than 1 cm on CT scan
* Lymphadenopathy allowed if biopsy proof of a benign cause
* No metastases by contrast CT or MRI scan of the brain, bone scan, CT scan of the lungs to exclude other ipsilateral or contralateral parenchymal lesions, and contrast CT scan of the upper abdomen including entire liver and adrenals
* No hepatomegaly or splenomegaly by physical examination or CT scan unless documentation of a benign cause
* No pericardial effusion
* No superior vena cava syndrome
* No prior diagnosis of lung cancer
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 90-100% (70-80% allowed if albumin at least 0.85 times lower limit of normal and weight loss no greater than 10% within 3 months before diagnosis)
Hematopoietic:
* White blood cell count (WBC) at least 4,000/mm\^3 OR
* Granulocyte count at least 2,000/mm\^3
* Platelet count normal
* Hemoglobin at least 10.0 g/dL (less than 8.5 g/dL allowed if no marrow involvement with tumor)
Hepatic:
* See Performance status
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)\*
* Serum glutamate oxaloacetate transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) no greater than 1.5 times ULN\* NOTE: \* Unless documentation of a benign cause
Renal:
* Creatinine clearance at least 50 mL/min
Cardiovascular:
* No myocardial infarction within the past 3 months
* No active angina
* No unstable arrhythmia
* No congestive heart failure
Pulmonary:
* Forced expiratory volume at one second (FEV1) at least 2.0 liters OR
* Predicted postresection FEV1 at least 800 mL based on quantitative V/Q scan
* Diffusion capacity of lung for carbon monoxide (DLCO) at least 50% predicted (corrected for hemoglobin) if pneumonectomy planned or likely after induction chemotherapy
Other:
* No clinically significant hearing loss unless willing to accept the potential of further loss
* No symptomatic peripheral neuropathy
* No peptic ulcer disease under active treatment
* No other medical illness not controllable by appropriate medical therapy
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or ductal or lobular carcinoma in situ of the breast
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent colony-stimulating factors
Chemotherapy:
* No prior chemotherapy for lung cancer
* No concurrent chemotherapy for another condition (such as arthritis)
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy for lung cancer
Surgery:
* See Disease Characteristics
* No prior resection of primary tumorReferences
Publications (6)
- BACKGROUNDMachtay M, Bae K, Movsas B, Paulus R, Gore EM, Komaki R, Albain K, Sause WT, Curran WJ. Higher biologically effective dose of radiotherapy is associated with improved outcomes for locally advanced non-small cell lung carcinoma treated with chemoradiation: an analysis of the Radiation Therapy Oncology Group. Int J Radiat Oncol Biol Phys. 2012 Jan 1;82(1):425-34. doi: 10.1016/j.ijrobp.2010.09.004. Epub 2010 Oct 25. PMID 20980108
- BACKGROUNDMachtay M, Swann S, Komaki R, et al.: What is the meaning of local-regional control after chemoradiation for locally advanced NSCLC? An RTOG analysis. [Abstract] Lung Cancer 50 (Suppl 2): A-O-041, S17, 2005.
- RESULTAlbain KS, Swann RS, Rusch VW, Turrisi AT 3rd, Shepherd FA, Smith C, Chen Y, Livingston RB, Feins RH, Gandara DR, Fry WA, Darling G, Johnson DH, Green MR, Miller RC, Ley J, Sause WT, Cox JD. Radiotherapy plus chemotherapy with or without surgical resection for stage III non-small-cell lung cancer: a phase III randomised controlled trial. Lancet. 2009 Aug 1;374(9687):379-86. doi: 10.1016/S0140-6736(09)60737-6. Epub 2009 Jul 24. PMID 19632716
- RESULTAlbain KS, Swann RS, Rusch VR, et al.: Phase III study of concurrent chemotherapy and radiotherapy (CT/RT) vs CT/RT followed by surgical resection for stage IIIA(pN2) non-small cell lung cancer (NSCLC): outcomes update of North American Intergroup 0139 (RTOG 9309). [Abstract] J Clin Oncol 23 (Suppl 16): A-7014, 624s, 2005.
- RESULTAlbain KS, Scott CB, Rusch VR, et al.: Phase III comparison of concurrent chemotherapy plus radiotherapy (CT/RT) and CT/RT followed by surgical resection for stage IIIA(pN2) non-small cell lung cancer (NSCLC): initial results from intergroup trial 0139 (RTOG 93-09) . [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2497, 2003.
- RESULTTurrisi AT, Scott CB, Rusch VR, et al.: Randomized trial of chemoradiotherapy to 61 Gy [no S] versus chemoradiotherapy to 45 Gy followed by surgery [S] using cisplatin etoposide in stage IIIa non-small cell lung cancer (NSCLC): intergroup trial 0139, RTOG (9309). [Abstract] Int J Radiat Oncol Biol Phys 57 (2 Suppl): S125-6, 2003.