The Optimal Intervention Time of Radiotherapy for Oligometastatic Stage IV Non-small Cell Lung Cancer（NSCLC） (OITROLC)

University of Electronic Science and Technology of China (UESTC)

Status and phase: Unknown; Phase 3

Conditions: Oligo-metastatic Stage IV Non-small Cell Lung Cancer

Treatments: Drug: Cisplatin; Radiation: concurrent chemoradiotherapy; Drug: Docetaxel; Drug: pemetrexed

Study type: Interventional

Funder types: Other

Identifiers

NCT02076477

scch201402

Details and patient eligibility

About

This study evaluates the optimal intervention time of radiotherapy for oligometastatic stage iv lung cancer.

Enrollment: 420 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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420 participants in 2 patient groups

Arm A

Experimental group

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.

Treatment:

Drug: Cisplatin

Radiation: concurrent chemoradiotherapy

Drug: Docetaxel

Drug: pemetrexed

Arm B

Active Comparator group

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.

Treatment:

Drug: Cisplatin

Radiation: concurrent chemoradiotherapy

Drug: Docetaxel

Drug: pemetrexed