The Optimal Intervention Time of Radiotherapy for Oligometastatic Stage IV Non-small Cell Lung Cancer(NSCLC) (OITROLC)
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ClinicalTrials.gov Identifier: NCT02076477 |
Recruitment Status : Unknown
Verified March 2020 by LI TAO, Sichuan Cancer Hospital and Research Institute.
Recruitment status was: Recruiting
First Posted : March 3, 2014
Last Update Posted : March 17, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Oligo-metastatic Stage IV Non-small Cell Lung Cancer | Radiation: concurrent chemoradiotherapy Drug: Docetaxel Drug: pemetrexed Drug: Cisplatin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 420 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Prospective,Multicenter,Randomized Controlled Clinical Study of the Optimal Intervention Time of Radiotherapy for Oligometastatic Stage IV Non-small Cell Lung Cancer(NSCLC) |
Study Start Date : | January 2014 |
Estimated Primary Completion Date : | October 2020 |
Estimated Study Completion Date : | October 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm A
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. |
Radiation: concurrent chemoradiotherapy
Radiation(image-guided radiotherapy):(1)primary tumors≤3cm,Hypofractionated radiation therapy,accumulated dose BED ≥80Gy (central lung cancer),BED ≥100Gy(Peripheral lung cancer).(2)primary tumors>3cm,conventional fractionated radiotherapy,accumulated dose BED=60-66Gy/30-33f.(3) regional lymph node:conventional fractionated radiotherapy,accumulated dose BED=60-66Gy/30-33f.(4) Brain metastases: whole brain radiation therapy,36Gy/12f,Intracranial metastases,48Gy/12f.(5) bone metastasis:36 Gy/12f. Drug: Docetaxel Docetaxel:60mg/m2 d1,Given IV Drug: pemetrexed pemetrexed: 500mg/m2 d1,Given IV Drug: Cisplatin Cisplatin:25mg/m2 d1-3,Given IV |
Active Comparator: Arm B
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. |
Radiation: concurrent chemoradiotherapy
Radiation(image-guided radiotherapy):(1)primary tumors≤3cm,Hypofractionated radiation therapy,accumulated dose BED ≥80Gy (central lung cancer),BED ≥100Gy(Peripheral lung cancer).(2)primary tumors>3cm,conventional fractionated radiotherapy,accumulated dose BED=60-66Gy/30-33f.(3) regional lymph node:conventional fractionated radiotherapy,accumulated dose BED=60-66Gy/30-33f.(4) Brain metastases: whole brain radiation therapy,36Gy/12f,Intracranial metastases,48Gy/12f.(5) bone metastasis:36 Gy/12f. Drug: Docetaxel Docetaxel:60mg/m2 d1,Given IV Drug: pemetrexed pemetrexed: 500mg/m2 d1,Given IV Drug: Cisplatin Cisplatin:25mg/m2 d1-3,Given IV |
- short-term effects(The response rate,RR) [ Time Frame: 3 months after the end of the treatment ]Response Evaluation Criteria In Solid Tumors (RECIST)
- PFS(progression-free survival) [ Time Frame: up to 3 years ]
- Quality of life (QOL) [ Time Frame: up to 3 years ]Quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-Trial Outcome Index (FACT-TOI) and lung cancer subscale (LCS)
- esophagitis and pneumonitis [ Time Frame: up to 3 years ]Grade 3-5 esophagitis and pneumonitis adverse events as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0
- Other grade 3-5 adverse events [ Time Frame: up to 3 years ]Other grade 3-5 adverse events as assessed by NCI CTCAE v3.0

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02076477
Contact: TAO LI, MD, PhD | 86-18908178818 | litaoxmf@126.com |
China, Sichuan | |
Sichuan Cancer Hospital & Institute | Recruiting |
Chengdu, Sichuan, China, 610041 | |
Contact: TAO LI, MD, PhD 86-18908178818 litaoxmf@163.com | |
Principal Investigator: TAO LI, MD, PhD | |
Sub-Investigator: XIAOHU WANG, MD, PhD | |
Sub-Investigator: XIAOBO DU, MD, PhD | |
Sub-Investigator: BING LU, MD, PhD |
Principal Investigator: | JIAHUA LV, MD | Sichuan Cancer Hospital & Institute | |
Principal Investigator: | XIAOHU WANG, MD, PhD | Gansu Cancer Hospital | |
Principal Investigator: | XIAOBO DU, MD, PhD | Mianyang Central Hospital | |
Principal Investigator: | BING LU, MD.PhD | Cancer Hospital of Guizhou Province |
Responsible Party: | LI TAO, Section Head, Sichuan Cancer Hospital and Research Institute |
ClinicalTrials.gov Identifier: | NCT02076477 |
Other Study ID Numbers: |
scch201402 |
First Posted: | March 3, 2014 Key Record Dates |
Last Update Posted: | March 17, 2020 |
Last Verified: | March 2020 |
intervention time radiotherapy oligometastatic non-small cell lung cancer |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |
Docetaxel Pemetrexed Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |