Non Small Cell Lung Cancer, OligometastaticPhase 2ROLENCT01796288
The Value of Radiotherapy in the Oligometastatic Non-squamous Non-small Cell Lung Cancer With Clinical Benefits From Erlotinib as Second-line Treatment
A Phase 2 study testing simultaneous radiotherapy and Erlotinib in people with Non Small Cell Lung Cancer, Oligometastatic, run by Wu Jieping Medical Foundation at 1 site in China.
Trial summary
This was a multi-center randomized controlled Phase II clinical trial. Patients with oligometastatic stage IV (number of distant metastases ≤ 5) non-squamous non-small cell lung cancer treated with second-line erlotinib150mg daily for 3 months with clinical benefits (free-from progression) were randomized (stratified… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non Small Cell Lung Cancer, Oligometastatic
- What is being tested?
- simultaneous radiotherapy and Erlotinib
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Oct 2012to Oct 2017
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has signed informed consent;
- Male or female aged 18 years or older;
- Histologically or cytologically identified non-squamous non-small cell lung cancer;
- PS score 0-2;
- Stage IV patients with distant metastasis (according to the latest AJCC/UICC lung cancer staging, upper neck lymph nodes belonging to distant metastases; ipsilateral/contralateral mediastinal lymph nodes, supraclavicular and lower neck lymph nodes belonging to local regional areas and are not included in distant metastases), who occurred disease progression after receiving a course of systemic chemotherapy, or who hadn't complete the planned course of the first-line chemotherapy but they were intolerance or refused to continue treatment;
- Received second-line erlotinib treatment;
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- The patients who taking erlotinib for 3 months then the efficacy evaluation found clinical benefits (CR+PR+SD);
- Metastatic NSCLC with distant metastases number ≤ 5 (for metastases in the same organ, the number counted as the separate metastatic focus) and the longest diameter of each metastatic foci on CT should > 1cm, but brain (including the parenchyma and meninges) metastasis, malignant pleural/pericardial effusion, or abdominal effusion were not allowed;
- Have never received local treatment, including surgery, radiation therapy, and radiofrequency ablation for primary and distant metastases;
- Patients must received systemic PET-CT examination before treatment with erlotinib, to more accurately identify the status of patients with distant metastases;
- The diagnosis of bone and liver metastases:
- On the basis of clinical symptoms, an imaging support was necessary for the clinical diagnosis of bone metastases; if the clinical symptoms were absent, two imaging supports of bone metastases were necessary for the clinical diagnosis of bone metastasis; adjacent bone metastases (such as the two adjacent vertebral metastases) was considered to be a single metastasis.
- MRI or enhanced CT confirmations were needed for liver metastases diagnosis;
- Have never received other targeted drug treatments for EGFR inhibition;
- If metastases in a same organ ≤ 4 and the amount of metastatic focus ≤ 5, it should be determined by the radiation therapists in the research group to judge if the patients can tolerate all positive focus (including primary and metastatic focus) receiving radiotherapy, the radiotherapy dose should be selected by treating physician according to the patients' conditions from several regimens including conventional split curative doses or palliative doses, and hypofractionated radiotherapy (for details please refer to the radiation therapy section);
- Organ function levels must meet the following requirements:
- Bone marrow: absolute neutrophil count (ANC) ≥ 1.0 × 109/L, platelets ≥ 80 × 109/L, hemoglobin ≥ 9 g/L;
- Liver: serum bilirubin ≤ 1.5 times of the upper limit of normal, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times of the upper limit of normal (if liver metastases existing, ALT, AST ≤ 5 times of the upper limit of normal were allowed) ;
- Kidney: serum creatinine ≤ 2 times of the upper limit of normal or creatinine clearance ≥ 45mL/min;
- For female patients: must after natural menopause, surgical menopause, or used any medical allowed contraceptive method during treatment and within 3 months after treatment completion; serum or urine pregnancy test must be negative; mustn't be in lactation. For male patients: surgical sterilization, or took contraceptive measures during treatment and within 3 months after treatment completion.
Who cannot join
- The pathological type was squamous cell carcinoma, or mixed with small cell components in non-small cell lung cancer;
- With brain metastasis regardless of parenchymal or meningeal metastasis;
- Malignant pleural effusion, pericardial effusion or peritoneal effusion;
- The longest diameter of metastatic focus on CT were <1cm, or the amount of metastatic focus > 5;
- Metastases appeared within a same organ simultaneously;
- The efficacy evaluation after erlotinib treatment for 3 months showed PD (progression of disease);
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- Local treatment had been used for the primary and distant metastatic focus;
- Radiation therapists thought that the patient couldn't tolerate/receive radiotherapy for all the focus;
- Has previously suffered from interstitial lung disease, drug-induced interstitial lung disease, or any active interstitial lung disease with clinical evidences;
- Chest CT found idiopathic pulmonary fibrosis;
- Patients with multiple pulmonary bullae, chronic lung disease, or acute lung infection;
- With any chronic toxicity induced by previous anti-cancer treatment, it was undimunished and higher than CTCAE level 2;
- Diagnosed or accompanied by any other malignant disease (except basal cell carcinoma or cervical carcinoma in situ) over the past five years;
- According to the judgments of the investigators, there was any serious or uncontrolled systemic disease (e.g. heart, liver, or kidney disease) or active infection;
- Combined use with phenytoin, carbamazepine, rifampicin, phenobarbital, or St. John's wort;
- Naïve patients who have never received chemotherapy;
- With previously clear history of neurological or psychiatric disorder, such as dementia;
- Pregnancy or lactating patients;
- Patients receiving other anti-tumor medicine not for this study.
Trial locations and contacts
1 site in 1 country.
Xiaolong Fu, ph.D&MD contact
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Xiaolong Fu, ph.D&MD, xlfu1964@126.com
Xiaolong Fu, ph.D&MD
About this study
Official title: The Value of Radiotherapy in the Oligometastatic Non-squamous Non-small Cell Lung Cancer With Clinical Benefits From Erlotinib as Second-line Treatment: a Randomized Controlled Phase II Clinical Trial
This was a multi-center randomized controlled Phase II clinical trial. Patients with oligometastatic stage IV (number of distant metastases ≤ 5) non-squamous non-small cell lung cancer treated with second-line erlotinib150mg daily for 3 months with clinical benefits (free-from progression) were randomized (stratified according to smoking status and different research centers) to the radiotherapy group (n = 100) and the non-radiotherapy group (n = 100). Radiotherapy group (experimental group) patients started simultaneously radiotherapy for all gross tumors soon after randomization; non-radiotherapy group (control group) received no radiotherapy for all gross tumors. Erlotinib was continuously used until to disease progression or unbearable adverse effect, and the subsequently further salvage therapies were determined by the investigators. The primary endpoint was PFS.
- Being tested
- simultaneous radiotherapy, Erlotinib
- Keywords
- NSCLC, oligometastatic, second-line, Radiotherapy, Erlotinib
- 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.
simultaneous radiotherapyRadiation
ErlotinibDrug
| Study group | Role | What they receive |
|---|---|---|
| Erlotinib & simultaneous radiotherapy | Experimental | patients started simultaneously radiotherapy for all gross tumors Receives: Radiation: simultaneous radiotherapy; Drug: Erlotinib |
| Erlotinib & no radiotherapy | Other | patients received no radiotherapy for all gross tumors Receives: Drug: Erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
progession-free survival
Measured: 3.5 year
Secondary outcomes (1)
overall survival
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2013 (estimated)
- Study startOct 2012
- Primary completionApr 2016 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung Cancer, OligometastaticStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wu Jieping Medical Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Chest Hospital, Shanghai Pulmonary Hospital, Shanghai, China, Fudan University, Zhejiang Cancer Hospital, Anhui Provincial Hospital, Anhui Medical University, Wuxi No. 4 People's Hospital
- Responsible party
- Principal investigator, FU XIAO LONG, Wu Jieping Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01796288
- Sponsor's protocol ID
- 1209114-5
- Acronym
- ROLE
- Status last verified
- Oct 2012
- First submitted
- 18 Feb 2013
- Last updated
- 21 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Radiotherapy in the Oligometastatic Non-squamous Non-small Cell Lung Cancer With Clinical Benefits From Erlotinib as Second-line Treatment: a Randomized Controlled Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT01796288
- Acronym / sponsor ID
- ROLE / 1209114-5
- Keywords
- NSCLC, oligometastatic, second-line, Radiotherapy, Erlotinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Wu Jieping Medical FoundationUniversity, hospital or other
- Collaborators
- Shanghai Chest Hospital, Shanghai Pulmonary Hospital, Shanghai, China, Fudan University, Zhejiang Cancer Hospital, Anhui Provincial Hospital, Anhui Medical University, Wuxi No. 4 People's Hospital
- Study start
- Oct 2012
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 21 Feb 2013 (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 was a multi-center randomized controlled Phase II clinical trial. Patients with oligometastatic stage IV (number of distant metastases ≤ 5) non-squamous non-small cell lung cancer treated with second-line erlotinib150mg daily for 3 months with clinical benefits (free-from progression) were randomized (stratified according to smoking status and different research centers) to the radiotherapy group (n = 100) and the non-radiotherapy group (n = 100). Radiotherapy group (experimental group) patients started simultaneously radiotherapy for all gross tumors soon after randomization; non-radiotherapy group (control group) received no radiotherapy for all gross tumors. Erlotinib was continuously used until to disease progression or unbearable adverse effect, and the subsequently further salvage therapies were determined by the investigators. The primary endpoint was PFS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erlotinib & simultaneous radiotherapy | Experimental | Radiation: simultaneous radiotherapy, Drug: Erlotinibpatients started simultaneously radiotherapy for all gross tumors |
| Erlotinib & no radiotherapy | Other | Drug: Erlotinibpatients received no radiotherapy for all gross tumors |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Has signed informed consent;
- Male or female aged 18 years or older;
- Histologically or cytologically identified non-squamous non-small cell lung cancer;
- PS score 0-2;
- Stage IV patients with distant metastasis (according to the latest AJCC/UICC lung cancer staging, upper neck lymph nodes belonging to distant metastases; ipsilateral/contralateral mediastinal lymph nodes, supraclavicular and lower neck lymph nodes belonging to local regional areas and are not included in distant metastases), who occurred disease progression after receiving a course of systemic chemotherapy, or who hadn't complete the planned course of the first-line chemotherapy but they were intolerance or refused to continue treatment;
Key exclusion criteria (19 listed)
- The pathological type was squamous cell carcinoma, or mixed with small cell components in non-small cell lung cancer;
- With brain metastasis regardless of parenchymal or meningeal metastasis;
- Malignant pleural effusion, pericardial effusion or peritoneal effusion;
- The longest diameter of metastatic focus on CT were <1cm, or the amount of metastatic focus > 5;
- Metastases appeared within a same organ simultaneously;
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 |
|---|---|---|
| simultaneous radiotherapy | Radiation | Erlotinib & simultaneous radiotherapy |
| Erlotinib | Drug | Erlotinib & no radiotherapy, Erlotinib & simultaneous radiotherapy |
Primary outcome
progession-free survival
Time frame: 3.5 year
1 secondary outcome
overall survival
Time frame: 5 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2013.
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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.
Xiaolong Fu, ph.D&MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing simultaneous radiotherapy and Erlotinib in people with Non Small Cell Lung Cancer, Oligometastatic, run by Wu Jieping Medical Foundation 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 20 inclusion and 19 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 21 Feb 2013. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Xiaolong Fu, ph.D&MD (xlfu1964@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progession-free survival (time frame: 3.5 year). 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 21 Feb 2013.