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

NCT02076477 | Unknown Phase 3 DMC

• 1 other identifier: scch201402
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Oligo-metastatic Stage IV Non-small Cell Lung Cancer

Keywords

intervention time; radiotherapy; oligometastatic; non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• short-term effects（The response rate，RR）

  Response Evaluation Criteria In Solid Tumors (RECIST)

  3 months after the end of the treatment

Secondary Outcomes (4)

• PFS（progression-free survival）

  up to 3 years

• Quality of life (QOL)

  up to 3 years

• esophagitis and pneumonitis

  up to 3 years

• Other grade 3-5 adverse events

  up to 3 years

Study Arms (2)

Arm A

EXPERIMENTAL

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; Drug: Docetaxel; Drug: pemetrexed; Drug: Cisplatin

Arm B

ACTIVE COMPARATOR

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; Drug: Docetaxel; Drug: pemetrexed; Drug: Cisplatin

Interventions

concurrent chemoradiotherapy RADIATION

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.

Arm A; Arm B

Docetaxel DRUG

Docetaxel:60mg/m2 d1,Given IV

Arm A; Arm B

pemetrexed DRUG

pemetrexed: 500mg/m2 d1,Given IV

Arm A; Arm B

Cisplatin DRUG

Cisplatin：25mg/m2 d1-3，Given IV

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sichuan Cancer Hospital and Research Institute: lead
• Mianyang Central Hospital: collaborator
• Cancer Hospital of Guizhou Province: collaborator

Study Sites (1)

Sichuan Cancer Hospital & Institute

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Chemoradiotherapy; Docetaxel; Pemetrexed; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• JIAHUA LV, MD

  Sichuan Cancer Hospital and Research 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

TAO LI, MD, PhD

CONTACT

86-18908178818; litaoxmf@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Section Head

Study Record Dates

• First Submitted: February 24, 2014
• First Posted: March 3, 2014
• Study Start: January 1, 2014
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: March 17, 2020

Record last verified: 2020-03

Locations

CN (1)