Clinical trial · Interventional
Chemotherapy Plus Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer That Cannot Be Surgically Removed
A Randomized Phase III Study Comparing Induction Chemotherapy to Daily Low Dose Cisplatin Both Combined With High Dose Radiotherapy Using Concomitant Boost Technique in Patients With Inoperable Non-Small Cell Lung Cancer Stage I, II, and Low Volume Stage III
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low accrual
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. Radiation therapy used high-energy x-rays to damage tumor cells. It is not yet know whether chemotherapy followed by radiation therapy is more effective than chemotherapy given with radiation therapy for non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of chemotherapy and radiation therapy in treating patients who have unresectable stage I, stage II, or 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed non-small cell lung cancer
* Stage I, II, III (T1-4, N0-3, M0)
* No metastases to supraclavicular, contralateral hilar, or contralateral scalene lymph nodes
* Medically inoperable or unresectable
* No pleural or pericardial effusion (except with repeated negative cytology)
PATIENT CHARACTERISTICS:
Age:
* Over 18
Performance status:
* ECOG 0 or 1
Life expectancy:
* Not specified
Hematopoietic:
* WBC at least 4,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 6.8 g/dL
* No hemoptysis causing a decrease of hemoglobin of 1 g/dL or more within 24 hours
Hepatic:
* Not specified
Renal:
* Creatinine no greater than 1.25 times normal OR
* Creatinine clearance greater than 70 mL/min
Cardiovascular:
* No evidence of heart failure
* No myocardial infarction within the past 6 months
* No superior vena cava syndrome
Pulmonary:
* FEV1 at least 1 L
* No pre-existing fibrotic lung disease
* No postobstructive pneumonia preventing exact delineation of tumor volume
* Diffusion capacity at least 60%
Other:
* No weight loss of more than 10% in the past 3 months
* No uncontrolled infection
* No serious medical risk factors involving any of the major organ systems that would preclude adherence to the study treatment schedule
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent immunotherapy
Chemotherapy:
* No prior chemotherapy
* No other concurrent chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy to the chest
* Maximum length of the esophagus receiving 40 Gy no greater than 18 cm
* Maximum length of the esophagus receiving 66 Gy no greater than 12 cm
* Must limit the spinal cord dose to a maximum of 50 Gy
* Must be able to exclude 25% of the heart from the boost volume
Surgery:
* Not specified
Other:
* No other concurrent experimental medicationsReferences
Publications (1)
- RESULTBelderbos J, Uitterhoeve L, van Zandwijk N, Belderbos H, Rodrigus P, van de Vaart P, Price A, van Walree N, Legrand C, Dussenne S, Bartelink H, Giaccone G, Koning C; EORTC LCG and RT Group. Randomised trial of sequential versus concurrent chemo-radiotherapy in patients with inoperable non-small cell lung cancer (EORTC 08972-22973). Eur J Cancer. 2007 Jan;43(1):114-21. doi: 10.1016/j.ejca.2006.09.005. Epub 2006 Nov 3. PMID 17084621