Clinical trial · Interventional
The Optimal Intervention Time of Radiotherapy for Oligometastatic Stage IV Non-small Cell Lung Cancer(NSCLC)
The Prospective,Multicenter,Randomized Controlled Clinical Study of the Optimal Intervention Time of Radiotherapy for Oligometastatic Stage IV Non-small Cell Lung Cancer(NSCLC)
NCT02076477CI-TRIAL-00044054OITROLCunknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study evaluates the optimal intervention time of radiotherapy for oligometastatic stage iv 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 |
|---|---|---|---|
| Oligo-metastatic Stage IV Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| concurrent chemoradiotherapy | Radiation | — | UNRESOLVED |
| Docetaxel | Drug | Docetaxel | ALIAS |
| pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Patients receive concurrent chemoradiotherapy at first。Patients also receive chemotherapy every 3-4 weeks for two cycles after concurrent chemoradiotherapy. chemotherapy:(1) squamous cell carcinoma:Docetaxel 60mg/m2 d1+Cisplatin 25mg/m2 d1-3.(2)non squamous cell carcinoma: pemetrexed 500mg/m2 d1+Cisplatin 25mg/m2 d1-3.
- interventionNames
- Radiation: concurrent chemoradiotherapy
- Drug: Docetaxel
- Drug: pemetrexed
- Drug: Cisplatin
- type
- ACTIVE_COMPARATOR
- label
- Arm B
- description
- Patients receive neoadjuvant chemotherapy every 3-4 weeks for two cycles at first.Patients then receive concurrent chemoradiotherapy after neoadjuvant chemotherapy. chemotherapy:(1) squamous cell carcinoma:Docetaxel 60mg/m2 d1+Cisplatin 25mg/m2 d1-3.(2)non squamous cell carcinoma: pemetrexed 500mg/m2 d1+Cisplatin 25mg/m2 d1-3.
- interventionNames
- Radiation: concurrent chemoradiotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 18 to 75 years old , male or female * Pathologically or cytologically proven oligometastatic stage IV NSCLC non-small cell lung cancer(NSCLC) * Primary tumors can be measured * Distant organ metastases number ≤ 5 * Karnofsky score \>70,Zubrod performance status 0-1 * Estimated life expectancy of at least 12 weeks * reproductive age women should ensure that before entering the study period contraception * Hemoglobin≥10.0g/dL,WBC≥ 4000 cells/mm³,Platelet count≥100,000 cells/mm³ * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 times upper limit of normal,bilirubin normal * Creatinine normal OR creatinine clearance ≥ 60 mL/min * Patients have good compliance to treatment and follow-up of acceptance. Exclusion Criteria: * Allergic to pemetrexed, cisplatin, docetaxel and contrast medium * Distant metastases organs \> 5 * The primary tumor or lymph node already received surgical treatment (except for biopsy) * Patient who received radiotherapy for primary tumor or lymph node * Patient who received the the epidermal growth factor targeted therapy * Patient who received chemotherapy or immunotherapy * Patient who suffered from other malignant tumor * Patient who have taken other drug test within 1 month * Pregnant woman or Lactating Women and Women in productive age who refuse to take contraception in observation period * Subject with a severe allergic history or idiosyncratic * Subject with severe pulmonary and cardiopathic disease history * Refuse or incapable to sign the informed consent form of participating this trial * Drug abuse or alcohol addicted * Subject with a Personality or psychiatric diseases, people with no legal capacity or people with limited capacity for civil conduct
References
Publications (0)
Data not yet available
No reference posted for this study.