Oligo-metastatic Stage IV Non-small Cell Lung CancerPhase 3OITROLCNCT02076477
The Optimal Intervention Time of Radiotherapy for Oligometastatic Stage IV Non-small Cell Lung Cancer（NSCLC）
A Phase 3 study testing concurrent chemoradiotherapy, Docetaxel and pemetrexed in people with Oligo-metastatic Stage IV Non-small Cell Lung Cancer, run by Sichuan Cancer Hospital and Research Institute at 1 site in China.
Trial summary
This study evaluates the optimal intervention time of radiotherapy for oligometastatic stage iv lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Oligo-metastatic Stage IV Non-small Cell Lung Cancer
- What is being tested?
- concurrent chemoradiotherapy, Docetaxel and pemetrexed
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Oct 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sichuan Cancer Hospital & Institute
Chengdu, Sichuan, 610041
TAO LI, MD, PhD, 86-18908178818, litaoxmf@163.com
TAO LI, MD, PhD
About this study
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）
This study evaluates the optimal intervention time of radiotherapy for oligometastatic stage iv lung cancer.
- Being tested
- concurrent chemoradiotherapy, Docetaxel, pemetrexed, Cisplatin
- Keywords
- intervention time, radiotherapy, oligometastatic, non-small cell lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
concurrent chemoradiotherapyRadiation
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.
DocetaxelDrug
Docetaxel:60mg/m2 d1,Given IV
pemetrexedDrug
pemetrexed: 500mg/m2 d1,Given IV
CisplatinDrug
Cisplatin：25mg/m2 d1-3，Given IV
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Radiation: concurrent chemoradiotherapy; Drug: Docetaxel; Drug: pemetrexed; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
short-term effects（The response rate，RR）
Response Evaluation Criteria In Solid Tumors (RECIST)
Measured: 3 months after the end of the treatment
Secondary outcomes (4)
PFS（progression-free survival）
Measured: up to 3 years
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)
Measured: up to 3 years
esophagitis and pneumonitis
Grade 3-5 esophagitis and pneumonitis adverse events as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0
Measured: up to 3 years
Other grade 3-5 adverse events
Other grade 3-5 adverse events as assessed by NCI CTCAE v3.0
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oligo-metastatic Stage IV Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Cancer Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Mianyang Central Hospital, Cancer Hospital of Guizhou Province
- Responsible party
- Principal investigator, LI TAO, Sichuan Cancer Hospital and Research Institute
- Investigators
- JIAHUA LV, MD, Principal investigator, Sichuan Cancer Hospital and Research InstituteXIAOHU WANG, MD, PhD, Principal investigator, Gansu Cancer HospitalXIAOBO DU, MD, PhD, Principal investigator, Mianyang Central HospitalBING LU, MD.PhD, Principal investigator, Cancer Hospital of Guizhou Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02076477
- Sponsor's protocol ID
- scch201402
- Acronym
- OITROLC
- Status last verified
- Mar 2020
- First submitted
- 24 Feb 2014
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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）
- ClinicalTrials.gov ID
- NCT02076477
- Acronym / sponsor ID
- OITROLC / scch201402
- Keywords
- intervention time, radiotherapy, oligometastatic, non-small cell lung cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Sichuan Cancer Hospital and Research InstituteUniversity, hospital or other
- Collaborators
- Mianyang Central Hospital, Cancer Hospital of Guizhou Province
- Study start
- Jan 2014
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 3 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the optimal intervention time of radiotherapy for oligometastatic stage iv lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Radiation: concurrent chemoradiotherapy, Drug: Docetaxel, Drug: pemetrexed, Drug: CisplatinPatients 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. |
| Arm B | Active comparator | Radiation: concurrent chemoradiotherapy, Drug: Docetaxel, Drug: pemetrexed, Drug: CisplatinPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| concurrent chemoradiotherapyRadiation（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. | Radiation | Arm A, Arm B |
| DocetaxelDocetaxel:60mg/m2 d1,Given IV | Drug | Arm A, Arm B |
| pemetrexedpemetrexed: 500mg/m2 d1,Given IV | Drug | Arm A, Arm B |
| CisplatinCisplatin：25mg/m2 d1-3，Given IV | Drug | Arm A, Arm B |
Primary outcome
short-term effects（The response rate，RR）
Time frame: 3 months after the end of the treatment
Response Evaluation Criteria In Solid Tumors (RECIST)
4 secondary outcomes
PFS（progression-free survival）
Time frame: up to 3 years
Quality of life (QOL)
Time frame: up to 3 years
esophagitis and pneumonitis
Time frame: up to 3 years
Other grade 3-5 adverse events
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JIAHUA LV, MD principal investigator
Sichuan Cancer Hospital and Research Institute
XIAOHU WANG, MD, PhD principal investigator
Gansu Cancer Hospital
XIAOBO DU, MD, PhD principal investigator
Mianyang Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing concurrent chemoradiotherapy, Docetaxel and pemetrexed in people with Oligo-metastatic Stage IV Non-small Cell Lung Cancer, run by Sichuan Cancer Hospital and Research Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact TAO LI, MD, PhD (86-18908178818, litaoxmf@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
short-term effects（The response rate，RR） (time frame: 3 months after the end of the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.