Clinical trial · Interventional
Radiation Therapy or Observation After Chemotherapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer
A Randomized Phase II Study of Oligometastatic Stage IV Non-Small Cell Lung Cancer (NSCLC) Treated With Systemic Therapy Plus Either Radiotherapy to All Sites of Gross Residual Disease or No Radiotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was terminated prematurely due to slow accrual.
Summary
Brief summary (as posted)
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Sometimes, after chemotherapy, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether radiation therapy is more effective than observation after chemotherapy in treating non-small cell lung cancer. PURPOSE: This randomized phase II trial is studying how well radiation therapy works compared with observation after chemotherapy in treating patients with stage IV 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| clinical observation | Other | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Arm I
- description
- Patients undergo observation for 6 weeks.
- interventionNames
- Other: clinical observation
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
- interventionNames
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- Time from registration to death or last follow-up (up to 5 years)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
* Mixed histology allowed if all components are consistent with NSCLC
* Squamous cell histology allowed
* Stage IV disease
* Oligometastatic disease (M1 with 1-3 metastases)
* Patients with M1 disease that involves intrapulmonary metastases are eligible provided ≤ 40% of the total lung volume receives ≥ 20 Gy of radiotherapy
* Previously untreated disease OR achieved stable disease or partial response within 8 weeks after completion of 2-6 courses of standard platinum-based chemotherapy (administered every 3-4 weeks)
* Pleural effusion allowed provided it is minimal
* No history of or current brain metastases
* Patients who have had up to 3 brain metastases allowed provided they have been treated with not signs of progression
PATIENT CHARACTERISTICS:
* ECOG performance status 0-1
* Life expectancy ≥ 12 weeks
* Platelet count ≥ 100,00/mm\^3
* Hemoglobin ≥ 9 g/dL
* WBC ≥ 2,000/mm\^3
* Creatinine ≤ 2 times upper limit of normal
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Able to undergo radiotherapy, based on radiation oncology consultation
* Willing and able to comply with study treatment
* FEV\_1 ≥ 1 L
* No requirement for daily supplemental oxygen
* No second primary malignancy, except for any of the following:
* Carcinoma in situ of the cervix
* Nonmelanoma skin cancer
* History of low-grade (Gleason score ≤ 6) localized prostate cancer, even if diagnosed within the past 5 years
* Stage I breast cancer that was treated within the past 5 years
* Other malignancy that was diagnosed and definitely treated ≥ 5 years ago with no subsequent evidence of recurrence
* No concurrent severe and/or uncontrolled medical condition, including any of the following:
* Angina pectoris
* Congestive heart failure within the past 3 months, unless LVEF \> 40%
* Myocardial infarction within the past 6 months
* Cardiac arrhythmia
* No clinically significant infection
* No psychiatric illness or social situation that would limit compliance with study requirements
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior therapy for this cancer other than 2-6 courses of standard platinum-based chemotherapy with or without bevacizumab
* No prior radiotherapy to the treatment sites (e.g., primary lesion, clinically involved nodes, or metastatic lesions)
* No bevacizumab during and for 4 weeks after completion of radiotherapy
* No concurrent systemic chemotherapy
* No other maintenance systemic therapy during radiotherapy
* No other concurrent investigational agents for the primary neoplasm
* No concurrent intensity modulated radiotherapy
* No concurrent prophylactic nodal radiotherapyReferences
Publications (0)
Data not yet available