Non-small Cell Lung CancerPhase 2NCT02054819
Treating NSCLC Minimal Stage IV With Curative Intent
A Phase 2 study testing Induction chemotherapy and concurrent radiation and Consolidation: Radiation therapy to metastatic sites in people with Non-small Cell Lung Cancer, run by Leo W. Jenkins Cancer Center at 1 site in United States.
Trial summary
It is the hypothesis of this protocol that a subset of NSCLC patients with stage IVa disease can benefit from curative therapy and extends beyond the very limited subset of oligometastatic patients that have already been studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Induction chemotherapy and concurrent radiation and Consolidation: Radiation therapy to metastatic sites
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to 22 Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytological documented NSCLC, including squamous cell carcinoma, adenocarcinoma, large cell carcinoma including large cell neuroendocrine carcinoma and poorly differentiated (not otherwise specified - NOS) non-small cell lung cancer. Bronchial alveolar adenocarcinoma and totally resected tumors are excluded. All histology is to be reviewed at East Carolina University or designated participating center.
- Patients with Stage II-IIIB intra-thoracic disease with oligometastatic disease (hereafter referred to as "Stage IVa" disease) are eligible. Definition of Stage IVa:
- Metastatic disease; either biopsy proven or with strong radiographic evidence suggesting its existence.
- As determined by CT, MRI or PET no more than five distinct metastatic sites. All metastatic disease must be anatomically located in such a way as to permit a reasonable attempt at permanent ablation. Ablative measures may include surgery, stereotactic radiosurgery, and external beam therapy. Patients who meet the minimal metastatic disease requirement and who would otherwise have been staged II, IIIA or IIIB.
- Patients with tumors adjacent to a vertebral body are eligible as long as all gross disease can be encompassed in the radiation boost field.
- Patients must be ≥ 18 years of age.
Show all 19Show fewer
- Patients with Zubrod (ECOG) performance status ≤ 2.
- Adequate hematologic function defined as: absolute neutrophil count (ANC) ≥ 1000/mm3, platelets ≥ 75,000/mm3, and hemoglobin ≥ 8 g/dL (prior to transfusions); adequate hepatic function defined as: total bilirubin ≤ 3.0 mg/dl, and adequate renal function defined as a serum creatinine level ≤ 2.0 mg/dl.
- Forced expiratory volume (FEV1) ≥ 800ml.
- Patients with weight loss < 20% over the past 3 months.
- Patients with a pleural effusion that is proven cytologically negative or is too small to tap.
- Women of childbearing potential must agree to practice effective contraception throughout the study plus four weeks.
- Pretreatment evaluations required for eligibility include:
- A medical history, physical exam, and Zubrod performance status within 3 weeks prior to study entry.
- Complete blodd count (CBC) with differential and platelet count, and laboratory profile must be completed within 3 weeks prior to study entry.
- FEV1, CT scan of the chest or whole body PET (preferred), and a CT scan or MRI (preferred) of the brain within 4 weeks prior to study entry.
- For women of childbearing potential, a serum or urine pregnancy test within a week prior to the start of protocol treatment.
- Medical Oncology and Radiation Oncology consultation and approval.
- Patients must sign a study-specific consent form prior to study entry.
Who cannot join
- Prior systemic chemotherapy or radiotherapy that would interfere with delivery of treatment as outlined above as judged by the clinician.
- Cytologically malignant effusions.
- Metastatic disease beyond what is described in section 3.1.2.
- Active pulmonary infection not responsive to antimicrobial therapy.
- History of symptomatic interstitial pneumonitis.
- Significant symptomatic cardiac disease, i.e., unstable angina, uncompensated congestive heart failure, or uncontrolled cardiac ventricular arrhythmias.
Show all 11Show fewer
- Patients with > grade 2 neuropathy.
- Evidence of malignancy in the past 2 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other in situ cancers.
- Women who are pregnant or breast feeding.
- Women of childbearing potential who are unwilling to practice effective contraception.
- Patients who currently are participating in other clinical trials and/or who have participated in other clinical trials in the previous 30 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
Leo W. Jenkins Cancer Center
Greenville, North Carolina, 27834
About this study
Official title: A Pilot Study Treating Patients With Minimal Stage IV Non-Small Cell Lung Cancer (NSCLC) With Curative Intent
It is the hypothesis of this protocol that a subset of NSCLC patients with stage IVa disease can benefit from curative therapy and extends beyond the very limited subset of oligometastatic patients that have already been studied.
Read the detailed description
In this study, patiently will be aggressively treated with 4 cycles of full dose platinum-based chemotherapy with concurrent radiation therapy to the primary tumor and identified mediastinal lymph nodal metastatic drainage. Local curative radiation will then target the oligometastatic tumor sites.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Induction chemotherapy and concurrent radiation, Consolidation: Radiation therapy to metastatic sites
- Keywords
- lung cancer, NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction chemotherapy and concurrent radiationOther
Cycle 1: irinotecan 65mg/m2 and cisplatin 30 mg/m2 on Day 1 and 8 Q 21 days Cycles 2-4: irinotecan 65 mg/m2, and cisplatin 30 mg/m2 Day 1 and 8 Q 21 days PLUS radiation therapy 66 Gy/7weeks/33 daily fractions
Consolidation: Radiation therapy to metastatic sitesOther
At least 60 Gy total (taking into account a possible 3 Gy x 4 pre-treatment or equivalent) to all metastatic sites. For brain, 2.5 Gy x 14 to whole brain to follow stereotactic radiosurgery (SRS).
| Study group | Role | What they receive |
|---|---|---|
| Single arm study | Other | Induction chemotherapy and concurrent radiation to primary tumor Cycle 1: irinotecan 65mg/m2 and cisplatin 30 mg/m2 on Day 1 and 8 Q 21 days Cycles 2-4: irinotecan 65 mg/m2, and cisplatin 30 mg/m2 Day 1 and 8 Q 21 days PLUS radiation therapy 66 Gy/7weeks/33 daily fractions
Consolidation Radiation: therapy to metastatic sites At least 60 Gy total (taking into account a possible 3 Gy x 4 pre-treatment or equivalent) to all metastatic sites. Receives: Other: Induction chemotherapy and concurrent radiation; Other: Consolidation: Radiation therapy to metastatic sites |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measure time of survival from enrollment to death from any cause, assessed up to 100 months.
Measured: Anticipated medial survival time is 8 - 10 months, however, all participants will be followed until death, assessed up to 100 months.
Secondary outcomes (1)
New metastatic disease
Measure of time from patient entry to time of new disease or progression of disease or date of death from any cause, whichever came first, assessed up to 100 months.
Measured: Anticipated time to progression is unknown, however, all patients will be followed for survival, up to 100 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startJun 2013
- Primary completion22 Aug 2017
- Study completion22 Aug 2017
Why it stopped: Didn't meet accrual goal, change in standard of care.
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 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leo W. Jenkins Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- East Carolina University
- Responsible party
- Sponsor
- Investigators
- Paul Walker, MD, PhD, Principal investigator, Brody School of Medicine ar East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02054819
- Sponsor's protocol ID
- LJCC 2011-01
- Status last verified
- Mar 2018
- First submitted
- 26 Aug 2013
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Treating Patients With Minimal Stage IV Non-Small Cell Lung Cancer (NSCLC) With Curative Intent
- ClinicalTrials.gov ID
- NCT02054819
- Acronym / sponsor ID
- LJCC 2011-01
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- lung cancer, NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Didn't meet accrual goal, change in standard of care.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Leo W. Jenkins Cancer CenterUniversity, hospital or other
- Collaborators
- East Carolina University
- Study start
- Jun 2013
- Primary completion
- 22 Aug 2017 (actual)
- Study completion
- 22 Aug 2017 (actual)
- First posted
- 4 Feb 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.
It is the hypothesis of this protocol that a subset of NSCLC patients with stage IVa disease can benefit from curative therapy and extends beyond the very limited subset of oligometastatic patients that have already been studied.
Detailed description
In this study, patiently will be aggressively treated with 4 cycles of full dose platinum-based chemotherapy with concurrent radiation therapy to the primary tumor and identified mediastinal lymph nodal metastatic drainage. Local curative radiation will then target the oligometastatic tumor sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm study | Other | Other: Induction chemotherapy and concurrent radiation, Other: Consolidation: Radiation therapy to metastatic sitesInduction chemotherapy and concurrent radiation to primary tumor Cycle 1: irinotecan 65mg/m2 and cisplatin 30 mg/m2 on Day 1 and 8 Q 21 days Cycles 2-4: irinotecan 65 mg/m2, and cisplatin 30 mg/m2 Day 1 and 8 Q 21 days PLUS radiation therapy 66 Gy/7weeks/33 daily fractions Consolidation Radiation: therapy to metastatic sites At least 60 Gy total (taking into account a possible 3 Gy x 4 pre-treatment or equivalent) to all metastatic sites. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Histological or cytological documented NSCLC, including squamous cell carcinoma, adenocarcinoma, large cell carcinoma including large cell neuroendocrine carcinoma and poorly differentiated (not otherwise specified - NOS) non-small cell lung cancer. Bronchial alveolar adenocarcinoma and totally resected tumors are excluded. All histology is to be reviewed at East Carolina University or designated participating center.
- Patients with Stage II-IIIB intra-thoracic disease with oligometastatic disease (hereafter referred to as "Stage IVa" disease) are eligible. Definition of Stage IVa:
- Metastatic disease; either biopsy proven or with strong radiographic evidence suggesting its existence.
- As determined by CT, MRI or PET no more than five distinct metastatic sites. All metastatic disease must be anatomically located in such a way as to permit a reasonable attempt at permanent ablation. Ablative measures may include surgery, stereotactic radiosurgery, and external beam therapy. Patients who meet the minimal metastatic disease requirement and who would otherwise have been staged II, IIIA or IIIB.
- Patients with tumors adjacent to a vertebral body are eligible as long as all gross disease can be encompassed in the radiation boost field.
Key exclusion criteria (11 listed)
- Prior systemic chemotherapy or radiotherapy that would interfere with delivery of treatment as outlined above as judged by the clinician.
- Cytologically malignant effusions.
- Metastatic disease beyond what is described in section 3.1.2.
- Active pulmonary infection not responsive to antimicrobial therapy.
- History of symptomatic interstitial pneumonitis.
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 |
|---|---|---|
| Induction chemotherapy and concurrent radiationCycle 1: irinotecan 65mg/m2 and cisplatin 30 mg/m2 on Day 1 and 8 Q 21 days Cycles 2-4: irinotecan 65 mg/m2, and cisplatin 30 mg/m2 Day 1 and 8 Q 21 days PLUS radiation therapy 66 Gy/7weeks/33 daily fractions | Other | Single arm study |
| Consolidation: Radiation therapy to metastatic sitesAt least 60 Gy total (taking into account a possible 3 Gy x 4 pre-treatment or equivalent) to all metastatic sites. For brain, 2.5 Gy x 14 to whole brain to follow stereotactic radiosurgery (SRS). | Other | Single arm study |
Primary outcome
Overall survival
Time frame: Anticipated medial survival time is 8 - 10 months, however, all participants will be followed until death, assessed up to 100 months.
Measure time of survival from enrollment to death from any cause, assessed up to 100 months.
1 secondary outcome
New metastatic disease
Time frame: Anticipated time to progression is unknown, however, all patients will be followed for survival, up to 100 months.
Results and safety
The study was stopped early (reason given: Didn't meet accrual goal, change in standard of care.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
Related trials for Non-small Cell Lung Cancer
RecruitingPhase 3
A Study Comparing TAK-928 With Docetaxel in Adults With Non-Small Cell Lung Cancer
IO Resistant Squamous and Nonsquamous NSCLC
RecruitingPhase 3
MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013)
Non-small Cell Lung Cancer
Not yet recruitingPhase 1
A Phase 1 Trial of KAN-001 With Pembrolizumab, With or Without Chemotherapy, in Participants With PD-L1-Positive Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer
RecruitingObservational study
Assessing Benefits and Harms of Cannabis/Cannabinoid Use Among Cancer Patients Treated in Community Oncology Clinics
Breast Carcinoma, Colorectal Carcinoma
RecruitingPhase 2
Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change
Advanced Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma
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.
Paul Walker, MD, PhD principal investigator
Brody School of Medicine ar East Carolina University
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 Induction chemotherapy and concurrent radiation and Consolidation: Radiation therapy to metastatic sites in people with Non-small Cell Lung Cancer, run by Leo W. Jenkins Cancer Center 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 19 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: stopped early, as of the sponsor's last update on 21 Aug 2019. 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 stopped early (reason given: Didn't meet accrual goal, change in standard of care.). Results are not available in the source record.
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?
Overall survival (time frame: Anticipated medial survival time is 8 - 10 months, however, all participants will be followed until death, assessed up to 100 months.). 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 Aug 2019.