Clinical trial · Interventional
Preoperative Chemoradiotherapy vs. Chemotherapy Alone in NSCLC Patients
Preoperative Chemoradiotherapy vs. Chemotherapy Alone in Non-small Cell Lung Cancer (NSCLC) Patients With Mediastinal Lymph Node Metastases (Stage IIIA, N2): A Randomized Prospective Phase III Trial
- 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, such as docetaxel and cisplatin, 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. Giving chemotherapy with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known if chemotherapy plus radiation therapy is more effective than chemotherapy alone before surgery in treating non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying docetaxel and cisplatin with or without radiation therapy to see how well they work when given before surgery in treating patients with stage IIIA non-small cell lung cancer that has spread to lymph nodes in the chest.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A
- description
- Neoadjuvant Chemoradiotherapy + Chemotherapy + Surgery
- interventionNames
- Drug: Chemotherapy
- Radiation: Radiotherapy
- Procedure: Surgery
- type
- ACTIVE_COMPARATOR
- label
- Arm B
- description
- Neoadjuvant Chemotherapy + Surgery
- interventionNames
- Drug: Chemotherapy
- Procedure: Surgery
Primary outcomes (1)
- measure
- Event-free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed non-small cell lung cancer
* Squamous, adenosquamous, large cell, or poorly differentiated
* Stage IIIA (T1-3, N2, M0)
* N2 disease confirmed by 1 of the following:
* Mediastinoscopy
* Bronchoscopy with fine-needle aspiration or esophagoscopy
* All N3 lymph nodes must be negative by positron-emission tomography (PET) AND CT scan (\< 1 cm in the largest diameter)
* PET scan
* Both the primary tumor and at least 1 N2 lymph node must be positive in PET scan
* At least 1 of the PET scan positive N2 lymph nodes is positive in the CT scan (\> 1 cm in the largest diameter)
* All N3 lymph nodes negative in PET scan
PATIENT CHARACTERISTICS:
Age:
* 18 to 75
Performance status:
* WHO 0-1
Life expectancy:
* Not specified
Hematopoietic:
* WBC at least 4,000/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin normal
* AST/ALT no greater than 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase no greater than 2.5 times ULN
Renal:
* Creatinine clearance greater than 60 mL/min
Cardiovascular:
* Cardiac function normal
* No unstable cardiac disease requiring treatment
* No congestive heart failure
* No angina pectoris even if medically controlled
* No significant arrhythmia
* No myocardial infarction in the past 3 months
Pulmonary:
* Lung function appropriate
Neurologic:
* No history of significant neurologic or psychiatric disorders
* No psychotic disorders
* No dementia
* No seizures
Other:
* No other prior or concurrent malignancies except nonmelanoma skin cancer, adequately treated carcinoma in situ of the cervix, or any other neoplastic disease with a disease-free interval ≥ 5 years
* No active uncontrolled infection
* No uncontrolled diabetes mellitus
* No gastric ulcers
* No pre-existing peripheral neuropathy greater than grade 1
* No contraindications to corticosteroids
* No other serious underlying medical condition that would preclude study participation
* No socioeconomic or geographic condition that would preclude study participation
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior cytostatic chemotherapy
Endocrine therapy:
* No concurrent prednisone except for treatment of acute hypersensitivity reactions or chronic low-dose treatment initiated more than 6 months prior to study entry (i.e., no greater than 20 mg methylprednisolone or equivalent)
Radiotherapy:
* No prior radiotherapy to chest
Surgery:
* Not specified
Other:
* At least 30 days since participation in another clinical study
* No other concurrent experimental drugsReferences
Publications (2)
- BACKGROUNDTieu BH, Sanborn RE, Thomas CR Jr. Neoadjuvant therapy for resectable non-small cell lung cancer with mediastinal lymph node involvement. Thorac Surg Clin. 2008 Nov;18(4):403-15. doi: 10.1016/j.thorsurg.2008.07.004. PMID 19086609
- DERIVEDPless M, Stupp R, Ris HB, Stahel RA, Weder W, Thierstein S, Gerard MA, Xyrafas A, Fruh M, Cathomas R, Zippelius A, Roth A, Bijelovic M, Ochsenbein A, Meier UR, Mamot C, Rauch D, Gautschi O, Betticher DC, Mirimanoff RO, Peters S; SAKK Lung Cancer Project Group. Induction chemoradiation in stage IIIA/N2 non-small-cell lung cancer: a phase 3 randomised trial. Lancet. 2015 Sep 12;386(9998):1049-56. doi: 10.1016/S0140-6736(15)60294-X. Epub 2015 Aug 11. PMID 26275735