Stage III Non-small Cell Lung CancerPhase 2NCT01336543
Consolidation Chemotherapy/Concurrent Chemo-radiotherapy for Inoperable Stage III Non-small Cell Lung Cancer (NSCLC)
A Phase 2 study testing Chemotherapy following concurrent Chemoradiotherapy in people with Stage III Non-small Cell Lung Cancer, run by Syed Jafri at 1 site in United States.
Trial summary
This is a pilot phase II study of histology based consolidation chemotherapy in patients with inoperable stage III Non-Small Cell Lung Cancer (NSCLC) following concurrent chemo-radiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage III Non-small Cell Lung Cancer
- What is being tested?
- Chemotherapy following concurrent Chemoradiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Jul 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients 18 years and older with histology proven NSCLC with inoperable stage III A or IIIB disease.
- Inoperable stage III A defined by multiple and or/bulky N2 mediastinal lymph nodes on computed tomography (CT) scan such that in opinion of treating investigator, the patient was not a candidate for surgical resection.
- N2 disease must be documented by either biopsy, fluorodeoxyglucose positron emission tomography (PET), and or CT scan if nodes are more than 2 cm.
- Stage IIIB patients must have N3 or T4 status. N3 status must be documented by presence of contralateral (to the primary tumor) mediastinal lymph node or supraclavicular or scalene lymph node proven by either biopsy, fluorodeoxyglucose PET, or more than 2 cm on CT scan.
- No prior treatment for lung cancer
- ECOG Performance status of 0-1.
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- Initiation of consolidation chemotherapy within 4-8 weeks of concurrent chemo-radiotherapy without progression.
- Adequate organ function
- leukocytes >3,000/mcL
- absolute neutrophil count >1,500/mcL
- platelets >100,000/mcL
- total bilirubin within normal institutional limits
- AST (SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal
- creatinine within normal institutional limits OR
- creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- All labs should be obtained within 14 days prior to start of study drug treatment.
- Ability to give informed consent and willingness to adhere to study protocol.
Who cannot join
- Patient who have had prior treatment for lung cancer.
- Prior history of radiation to chest.
- Known malignancy other than the current cancer.
- Uncontrolled intercurrent illness including but not limited to ongoing active infection, history of cardiac disease, e.g. uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within last six months or ventricular arrhythmias requiring medication, psychiatric illness that would impair patients ability to comply with study requirements.
- Pregnant or lactating women (any women becoming pregnant during the study will be withdrawn from the study)
- Patient with documented or symptoms of peripheral neuropathy.
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- History of allergic reaction to compounds similar to the ones used in this study.
- Malignant effusions (pleural or pericardial)
- Superior sulcus (Pancoast) tumors.
- Any condition that would hamper ability to give informed consent or ability to comply with study protocol.
- HIV patients on anti-retroviral therapy are in-eligible to participate in this study because of potential interaction with the study drugs and increase susceptibility for infections during course of marrow suppressive chemotherapy and radiotherapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
LSU Health Sciences Center, 1501 Kings Highway
Shreveport, Louisiana, 71103
About this study
Official title: A Pilot Study: Phase II Study of Histology-based Consolidation Chemotherapy Following Concurrent Chemo-radiotherapy for Inoperable Stage III Non-small Cell Lung Cancer
This is a pilot phase II study of histology based consolidation chemotherapy in patients with inoperable stage III Non-Small Cell Lung Cancer (NSCLC) following concurrent chemo-radiotherapy. Patients with inoperable stage III NSCLC would be treated with standard concurrent chemo-radiotherapy and subsequently those with non-squamous histology would be offered 4 cycles of consolidation pemetrexed and those with squamous histology 4 cycles of consolidation with gemcitabine.
Read the detailed description
Non-Small Cell Lung Cancer (NSCLC) is the leading cause of cancer related mortality in US (1). About 22% of patients diagnosed with NSCLC have locally advanced or stage III disease at the time of diagnosis (2). 5 years survival for stage III lung cancer is 23% which is much less than survival in similar stage breast and Colon Cancers (2). Current standard of care for inoperable stage III NSCLC is concurrent chemo-radiotherapy as established by a study (Southwestern Oncology Group) SWOG 9019 (3). Surgery following concurrent chemo-radiotherapy has been evaluated in a large Phase III clinical trial in patients with Stage III (N2) disease which did not show any improvement in overall survival from surgery as compared to concurrent chemo-radiotherapy alone.(4). These two studies demonstrated that the most common site of cancer relapse in patients with stage III disease was distant metastasis, 65% (3) and 57% (4) respectively.
These observations have led to the idea that perhaps giving additional chemotherapy following definitive concurrent chemo-radiotherapy may prevent distant relapse in stage III NSCLC.
This idea was evaluated in a Phase II study SWOG S9504 in which patients with stage III NSCLC were treated with concurrent chemo-radiotherapy followed by 4 cycles of docetaxel consolidation (5). Four cycles of docetaxel consolidation showed an impressive improvement in median Overall Survival (OS) to 26 months.
This idea of docetaxel consolidation was subsequently evaluated in a large phase III trial in which patients inoperable stage III NSCLC after receiving concurrent chemo-radiotherapy were randomized to docetaxel consolidation versus observation (6). However, this study showed no improvement in OS between the docetaxel arm and the observation arm. Many patients in docetaxel arm developed pneumonitis and febrile neutropenia.
Histology based selection of chemotherapy is now standard of for stage IV metastatic NSCLC. A large randomized Phase III trial from Europe showed that a combination of Cisplatin and Pemetrexed is more effective in patients with non-squamous histology and a combination of Cisplatin and Gemcitabine showed efficacy in patients with squamous cell histology (7). Recently maintenance Pemetrexed was evaluated in advanced NSCLC and showed improvement in PFS and OS in patients with non-squamous histology (8). Similarly maintenance gemcitabine has also been evaluated in large Phase III clinical trial after initial chemotherapy with Cisplatin and Gemcitabine (9).
Since most patients with inoperable stage III NSCLC develop distant metastasis following definitive concurrent chemo-radiotherapy there clearly is a need to give addition treatment for these patients. Docetaxel consolidation has not been shown to be successful as noted above. Perhaps tailoring chemotherapy according to histology may result in improvement in PFS and OS in these patients.
Based on this hypothesis the investigators intend to do a pilot phase II study of histology based consolidation chemotherapy in patients with inoperable stage III NSCLC following concurrent chemo-radiotherapy. Patients with inoperable stage III NSCLC would be treated with standard concurrent chemo-radiotherapy and subsequently those with non-squamous histology would be offered 4 cycles of consolidation pemetrexed and those with squamous histology 4 cycles of consolidation with gemcitabine.
- Conditions
- Stage III Non-small Cell Lung Cancer
- Being tested
- Chemotherapy following concurrent Chemoradiotherapy
- Keywords
- Non small cell lung cancer, Inoperable Stage III, Inoperable, Stage III
- 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.
Chemotherapy following concurrent ChemoradiotherapyDrug
Also called Pemetrexed, Gemcitabine, Cisplatin, Etoposide
- NSCLC (Non-Small Cell Lung Cancer)
- PE (Cisplatin 50mg/m2 on days 1,8,29,36 Etoposide 80mg/m2 days 1-3 and 29-31)
- Radiation 59.4 Gy with 2 cycles of PE
- (Non-squamous histology) Pemetrexed consolidation 500mg/m2 every 21 days for 4 cycles
- (Squamous histology) Gemcitabine consolidation 1000mg/m2 days 1,8, every 21 days for 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Experimental | ACTIVE TREATMENT intervention below:
1. NSCLC (Non-Small Cell Lung Cancer)
2. PE (Cisplatin 50mg/m2 on days 1,8,29,36 Etoposide 60 mg/m2 days 1-3 and 29-31)
3. Radiation 59.4 Gy with 2 cycles of PE
4. (Non-squamous histology) Pemetrexed consolidation 500mg/m2 every 21 days for 4 cycles
5. (Squamous histology) Gemcitabine consolidation 1000mg/m2 days 1,8, every 21 days for 4 cycles Receives: Drug: Chemotherapy following concurrent Chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
From date of registration to date of first observation of progressive disease, death due to any cause or symptomatic deterioration.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionJul 2013
- Study completionJul 2013
Why it stopped: Low accrual, small patient population at center.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syed Jafri
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Syed Jafri, Louisiana State University Health Sciences Center Shreveport
- Investigators
- Syed H. Jafri, MD, Principal investigator, LSU Health Shreveport, Feist-Weiller Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01336543
- Sponsor's protocol ID
- H11-071
- Status last verified
- Dec 2014
- First submitted
- 12 Apr 2011
- Last updated
- 18 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study: Phase II Study of Histology-based Consolidation Chemotherapy Following Concurrent Chemo-radiotherapy for Inoperable Stage III Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01336543
- Acronym / sponsor ID
- H11-071
- Conditions
- Stage III Non-small Cell Lung Cancer
- Keywords
- Non small cell lung cancer, Inoperable Stage III, Inoperable, Stage III
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Low accrual, small patient population at center.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Syed JafriUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 18 Apr 2011 (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 is a pilot phase II study of histology based consolidation chemotherapy in patients with inoperable stage III Non-Small Cell Lung Cancer (NSCLC) following concurrent chemo-radiotherapy. Patients with inoperable stage III NSCLC would be treated with standard concurrent chemo-radiotherapy and subsequently those with non-squamous histology would be offered 4 cycles of consolidation pemetrexed and those with squamous histology 4 cycles of consolidation with gemcitabine.
Detailed description
Non-Small Cell Lung Cancer (NSCLC) is the leading cause of cancer related mortality in US (1). About 22% of patients diagnosed with NSCLC have locally advanced or stage III disease at the time of diagnosis (2). 5 years survival for stage III lung cancer is 23% which is much less than survival in similar stage breast and Colon Cancers (2). Current standard of care for inoperable stage III NSCLC is concurrent chemo-radiotherapy as established by a study (Southwestern Oncology Group) SWOG 9019 (3). Surgery following concurrent chemo-radiotherapy has been evaluated in a large Phase III clinical trial in patients with Stage III (N2) disease which did not show any improvement in overall survival from surgery as compared to concurrent chemo-radiotherapy alone.(4). These two studies demonstrated that the most common site of cancer relapse in patients with stage III disease was distant metastasis, 65% (3) and 57% (4) respectively.
These observations have led to the idea that perhaps giving additional chemotherapy following definitive concurrent chemo-radiotherapy may prevent distant relapse in stage III NSCLC.
This idea was evaluated in a Phase II study SWOG S9504 in which patients with stage III NSCLC were treated with concurrent chemo-radiotherapy followed by 4 cycles of docetaxel consolidation (5). Four cycles of docetaxel consolidation showed an impressive improvement in median Overall Survival (OS) to 26 months.
This idea of docetaxel consolidation was subsequently evaluated in a large phase III trial in which patients inoperable stage III NSCLC after receiving concurrent chemo-radiotherapy were randomized to docetaxel consolidation versus observation (6). However, this study showed no improvement in OS between the docetaxel arm and the observation arm. Many patients in docetaxel arm developed pneumonitis and febrile neutropenia.
Histology based selection of chemotherapy is now standard of for stage IV metastatic NSCLC. A large randomized Phase III trial from Europe showed that a combination of Cisplatin and Pemetrexed is more effective in patients with non-squamous histology and a combination of Cisplatin and Gemcitabine showed efficacy in patients with squamous cell histology (7). Recently maintenance Pemetrexed was evaluated in advanced NSCLC and showed improvement in PFS and OS in patients with non-squamous histology (8). Similarly maintenance gemcitabine has also been evaluated in large Phase III clinical trial after initial chemotherapy with Cisplatin and Gemcitabine (9).
Since most patients with inoperable stage III NSCLC develop distant metastasis following definitive concurrent chemo-radiotherapy there clearly is a need to give addition treatment for these patients. Docetaxel consolidation has not been shown to be successful as noted above. Perhaps tailoring chemotherapy according to histology may result in improvement in PFS and OS in these patients.
Based on this hypothesis the investigators intend to do a pilot phase II study of histology based consolidation chemotherapy in patients with inoperable stage III NSCLC following concurrent chemo-radiotherapy. Patients with inoperable stage III NSCLC would be treated with standard concurrent chemo-radiotherapy and subsequently those with non-squamous histology would be offered 4 cycles of consolidation pemetrexed and those with squamous histology 4 cycles of consolidation with gemcitabine.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Experimental | Drug: Chemotherapy following concurrent ChemoradiotherapyACTIVE TREATMENT intervention below: 1. NSCLC (Non-Small Cell Lung Cancer) 2. PE (Cisplatin 50mg/m2 on days 1,8,29,36 Etoposide 60 mg/m2 days 1-3 and 29-31) 3. Radiation 59.4 Gy with 2 cycles of PE 4. (Non-squamous histology) Pemetrexed consolidation 500mg/m2 every 21 days for 4 cycles 5. (Squamous histology) Gemcitabine consolidation 1000mg/m2 days 1,8, every 21 days for 4 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Adult patients 18 years and older with histology proven NSCLC with inoperable stage III A or IIIB disease.
- Inoperable stage III A defined by multiple and or/bulky N2 mediastinal lymph nodes on computed tomography (CT) scan such that in opinion of treating investigator, the patient was not a candidate for surgical resection.
- N2 disease must be documented by either biopsy, fluorodeoxyglucose positron emission tomography (PET), and or CT scan if nodes are more than 2 cm.
- Stage IIIB patients must have N3 or T4 status. N3 status must be documented by presence of contralateral (to the primary tumor) mediastinal lymph node or supraclavicular or scalene lymph node proven by either biopsy, fluorodeoxyglucose PET, or more than 2 cm on CT scan.
- No prior treatment for lung cancer
Key exclusion criteria (11 listed)
- Patient who have had prior treatment for lung cancer.
- Prior history of radiation to chest.
- Known malignancy other than the current cancer.
- Uncontrolled intercurrent illness including but not limited to ongoing active infection, history of cardiac disease, e.g. uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within last six months or ventricular arrhythmias requiring medication, psychiatric illness that would impair patients ability to comply with study requirements.
- Pregnant or lactating women (any women becoming pregnant during the study will be withdrawn from the study)
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 |
|---|---|---|
| Chemotherapy following concurrent ChemoradiotherapyAlso: Pemetrexed, Gemcitabine, Cisplatin, Etoposide1. NSCLC (Non-Small Cell Lung Cancer) 2. PE (Cisplatin 50mg/m2 on days 1,8,29,36 Etoposide 80mg/m2 days 1-3 and 29-31) 3. Radiation 59.4 Gy with 2 cycles of PE 4. (Non-squamous histology) Pemetrexed consolidation 500mg/m2 every 21 days for 4 cycles 5. (Squamous histology) Gemcitabine consolidation 1000mg/m2 days 1,8, every 21 days for 4 cycles | Drug | Active Treatment |
Primary outcome
Progression free survival
Time frame: 3 years
From date of registration to date of first observation of progressive disease, death due to any cause or symptomatic deterioration.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2014.
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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.
Syed H. Jafri, MD principal investigator
LSU Health Shreveport, Feist-Weiller Cancer Center
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 Chemotherapy following concurrent Chemoradiotherapy in people with Stage III Non-small Cell Lung Cancer, run by Syed Jafri at 1 site in United States.
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 17 inclusion and 11 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: withdrawn, as of the sponsor's last update on 18 Dec 2014. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: 3 years). 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 18 Dec 2014.