Back to results

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

Primary Purpose

Oligo-metastatic Stage IV Non-small Cell Lung Cancer

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

concurrent chemoradiotherapy

Docetaxel

pemetrexed

Cisplatin

About this trial

This is an interventional treatment trial for Oligo-metastatic Stage IV Non-small Cell Lung Cancer focused on measuring intervention time, radiotherapy, oligometastatic, non-small cell lung cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Sichuan Cancer Hospital & InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A

Arm B

Arm 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.

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.

Outcomes

Primary Outcome Measures

short-term effects（The response rate，RR）

Response Evaluation Criteria In Solid Tumors (RECIST)

Secondary Outcome Measures

PFS（progression-free survival）

Quality of life (QOL)

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

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

Other grade 3-5 adverse events as assessed by NCI CTCAE v3.0

Full Information

NCT ID

NCT02076477

First Posted

February 24, 2014

Last Updated

March 16, 2020

Sponsor

Sichuan Cancer Hospital and Research Institute

Collaborators

Mianyang Central Hospital, Cancer Hospital of Guizhou Province

1. Study Identification

Unique Protocol Identification Number

NCT02076477

Brief Title

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

Acronym

OITROLC

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 Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Unknown status

Study Start Date

January 2014 (undefined)

Primary Completion Date

October 2020 (Anticipated)

Study Completion Date

October 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sichuan Cancer Hospital and Research Institute

Collaborators

Mianyang Central Hospital, Cancer Hospital of Guizhou Province

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Oligo-metastatic Stage IV Non-small Cell Lung Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Experimental

Arm Description

Arm Title

Arm B

Arm Type

Active Comparator

Arm Description

Intervention Type

Radiation

Intervention Name(s)

concurrent chemoradiotherapy

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Intervention Description

Docetaxel:60mg/m2 d1,Given IV

Intervention Type

Drug

Intervention Name(s)

pemetrexed

Intervention Description

pemetrexed: 500mg/m2 d1,Given IV

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

Cisplatin：25mg/m2 d1-3，Given IV

Primary Outcome Measure Information:

Title

short-term effects（The response rate，RR）

Description

Response Evaluation Criteria In Solid Tumors (RECIST)

Time Frame

3 months after the end of the treatment

Secondary Outcome Measure Information:

Title

PFS（progression-free survival）

Time Frame

up to 3 years

Title

Quality of life (QOL)

Description

Quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-Trial Outcome Index (FACT-TOI) and lung cancer subscale (LCS)

Time Frame

up to 3 years

Title

esophagitis and pneumonitis

Description

Grade 3-5 esophagitis and pneumonitis adverse events as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0

Time Frame

up to 3 years

Title

Other grade 3-5 adverse events

Description

Other grade 3-5 adverse events as assessed by NCI CTCAE v3.0

Time Frame

up to 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

TAO LI, MD, PhD

Phone

86-18908178818

litaoxmf@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

JIAHUA LV, MD

Organizational Affiliation

Sichuan Cancer Hospital & Institute

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

XIAOHU WANG, MD, PhD

Organizational Affiliation

Gansu Cancer Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

XIAOBO DU, MD, PhD

Organizational Affiliation

Mianyang Central Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

BING LU, MD.PhD

Organizational Affiliation

Cancer Hospital of Guizhou Province

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sichuan Cancer Hospital & Institute

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610041

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

TAO LI, MD, PhD

Phone

86-18908178818

litaoxmf@163.com

First Name & Middle Initial & Last Name & Degree

TAO LI, MD, PhD

First Name & Middle Initial & Last Name & Degree

XIAOHU WANG, MD, PhD

First Name & Middle Initial & Last Name & Degree

XIAOBO DU, MD, PhD

First Name & Middle Initial & Last Name & Degree

BING LU, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs