Clinical trial · Interventional
Oxaliplatin, Docetaxel, and Radiation Therapy in Treating Patients With Unresectable Stage II/III or Recurrent NSCLC
Phase I Study of Oxaliplatin in Combination With Docetaxel and Radiotherapy in Patients With Unresectable or Recurrent Non-Small Cell Lung Cancer (NSCLC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Withdrawn due to lack of accrual
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin 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. Oxaliplatin and docetaxel may make tumor cells more sensitive to radiation therapy. Giving oxaliplatin and docetaxel together with radiation therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of oxaliplatin when given together with docetaxel and radiation therapy in treating patients with unresectable stage II or stage III or recurrent 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 |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
| radiation therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chemoradiation Treated Patients
- description
- Patients receiving Docetaxel, Oxaliplatin and radiotherapy.
- interventionNames
- Drug: docetaxel
- Drug: oxaliplatin
- Procedure: radiation therapy
Primary outcomes (1)
- measure
- Maximum tolerated dose of oxaliplatin in combination with docetaxel and radiotherapy
- timeFrame
- Within 90 days of radiotherapy
Secondary outcomes (2)
- measure
- Dose-limiting toxicities
- timeFrame
- Within 90 days of radiotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of non-small cell lung cancer (NSCLC) meeting 1 of the following criteria: * Medically inoperable or unresectable stage II, IIIA, or IIIB disease * Post-resection intrathoracic tumor recurrence * Measurable disease by computed tomography(CT) scan * No evidence of small cell histology * No significant pleural effusion on chest x-ray or malignant pleural effusion on cytology * No metastatic disease * Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1 * Absolute granulocyte count ≥ 2,000/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 8.0 g/dL * Bilirubin ≤ 1.5 mg/dL * Serum glutamic oxaloacetic transaminase (SGOT) ≤ 1.5 times upper limit of normal (unless abnormality is caused by documented benign disease) * Creatinine ≤ 1.5 mg/dL * Weight loss ≤ 10% within the past 3 months * Forced expiratory volume (FEV) 1 ≥ 1,000 cc * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after completion of study treatment Exclusion Criteria: * Synchronous (except for nonmelanomatous skin cancer) or prior invasive malignancy, unless disease free for \> 3 years * Myocardial infarction within the past 6 months * Symptomatic heart disease, including any of the following: * Angina * Congestive heart failure * Uncontrolled arrhythmia * Active infection or fever ≥ 38.5°C within the past 3 days * Known hypersensitivity to any of the components of oxaliplatin or docetaxel * Prior thoracic or neck radiotherapy * Prior docetaxel or oxaliplatin
References
Publications (0)
Data not yet available