Non Small Cell Lung CancerEarly Phase 1NCT02568033
Stereotactic Radiosurgery and Systemic Dose Chemotherapy for Locally Advanced Lung Cancer
A Early Phase 1 study testing Pemetrexed, Carboplatin and Cisplatin in people with Non Small Cell Lung Cancer, run by The Cooper Health System at 1 site in United States.
Trial summary
This is a pilot study looking at using stereotactic radiosurgery and full dose chemotherapy to treat stage II and III lung cancer that is not amendable to surgical resection. 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?
- Pemetrexed, Carboplatin and Cisplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Oct 2017
- Phase
- Early Phase 1
- 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
- Nonsmall cell lung cancer (NSCLC) (any histology)
- unresectable stage II
- Stage III
- Tumor less than 8 cm
- Karnofsky performance scale (KPS) of 50 or better
- Three or fewer mediastinal or hilar lymph nodes
Who cannot join
- Small cell lung cancer (SCLC)
- Stage I and stage IV patients
- Stage II patients eligible for surgical resection
- Concurrent severe disease that the treating physician feels will interfere with therapy this can include significant cardiovascular or pulmonary disease.
- KPS 40 or less (bed bound)
- Tumor size greater than 8 cm
- Inability to safely treat target lesions (at discretion of treating physician, this would most likely be secondary to not being able to place fiducial markers for tracking)
- Four or more medisatinal or hilar lymph nodes
Trial locations and contacts
1 site in 1 country.
Kimberly Krieger contact
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center at Cooper
Camden, New Jersey, 08103
Kim Krieger, 856-735-6237
About this study
Official title: Stereotactic Radiosurgery and Systemic Dose Chemotherapy for Locally Advanced Lung Cancer (Protocol Number GK001)
This is a pilot study looking at using stereotactic radiosurgery and full dose chemotherapy to treat stage II and III lung cancer that is not amendable to surgical resection.
Read the detailed description
Current standard of care for treatment of locally advanced (unresectable stage II and all of stage III) non-small cell lung cancer (NSCLC) is chemo-radiation which consists of 7 weeks of radiation and chemotherapy given at a reduced dose (as opposed to systemic dose when chemotherapy given by itself). While outcomes have improved over time they remain humbling, with current approaches associated with overall poor results both in terms of local (30% of patients have local failure) and distant control (40% of patients have distant failure) with a median overall survival of 17 months.
This study is evaluating treatment with full dose chemotherapy and stereotactic body radiotherapy (SBRT). SBRT uses high doses of radiation in a very precise and conformal manner, the number of treatments are much reduced versus conventional radiation (SBRT would be able to be completed in 2 weeks or less). The biologically effective dose of SBRT is much higher than that of conventional radiation; despite being a shorter number of treatments the effective radiation dose is higher. SBRT would be completed in 2 weeks and since radiation would be completed in a shorter time span, would allow patients to have higher (systemic) chemotherapy doses.
The purpose of this study is to explore SBRT in addition to systemic doses of chemotherapy in the treatment of locally advanced NSCLC.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Pemetrexed, Carboplatin, Cisplatin, Docetaxel, Paclitaxel
- 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.
PemetrexedDrug
Also called Alimta
CarboplatinDrug
CisplatinDrug
DocetaxelDrug
Also called taxotere
PaclitaxelDrug
Also called taxol
stereotactic radiosurgeryRadiation
Also called CK, cyberknife, cyber knife
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Chemotherapy:
for Non-Squamous Cell: Pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 on day 1 of 21 day cycle or Carboplatin AUC6 and Paclitaxel 75 mg/m2 on day 1 of 21 day cycle
for Squamous Cell: Cisplatin 75 mg/m2 and docetaxel 75mg m2 day 1 of 21 day cycle or Carboplatin AUC6 and paclitaxel 200 mg/m2 day 1 of 21 day cycle
Radiation- Stereotactic radiosurgery Peripheral Lung lesion: 60 Gy over 3 fractions Central Lung lesion: 50 Gy over 5 fractions Hilar and Mediastinal LNs 40-50Gy over 5 fractions
Schedule is:
2 cycles of chemotherapy, followed by SRS, followed by 2 additional cycles of chemotherapy. Receives: Drug: Pemetrexed; Drug: Carboplatin; Drug: Cisplatin; Drug: Docetaxel; Drug: Paclitaxel; Radiation: stereotactic radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free progression
Local control will be evaluated at end of treatment (4-6 months) and then at regular follow up intervals.
Measured: 4-6 months
Toxicity (Treatment related side effects)
Treatment related side effects will be monitored
Measured: 4-5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2015 (estimated)
- Study startOct 2013
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cooper Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02568033
- Sponsor's protocol ID
- 13-130
- Status last verified
- Jul 2016
- First submitted
- 2 Oct 2015
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Kubicek GJ, Khrizman P, Squillante C, Callahan K, Xu Q, Abouzgheib W, Boujaoude Z, Patel A, Hageboutros A. Stereotactic Body Radiotherapy and Systemic Dose Chemotherapy for Locally Advanced Lung Cancer: Single Arm Phase 2 Study. Am J Clin Oncol. 2022 Mar 1;45(3):129-133. doi: 10.1097/COC.0000000000000892.
PubMed 35195562
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Radiosurgery and Systemic Dose Chemotherapy for Locally Advanced Lung Cancer (Protocol Number GK001)
- ClinicalTrials.gov ID
- NCT02568033
- Acronym / sponsor ID
- 13-130
- Conditions
- Non Small Cell Lung Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- The Cooper Health SystemUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 5 Oct 2015 (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 study looking at using stereotactic radiosurgery and full dose chemotherapy to treat stage II and III lung cancer that is not amendable to surgical resection.
Detailed description
Current standard of care for treatment of locally advanced (unresectable stage II and all of stage III) non-small cell lung cancer (NSCLC) is chemo-radiation which consists of 7 weeks of radiation and chemotherapy given at a reduced dose (as opposed to systemic dose when chemotherapy given by itself). While outcomes have improved over time they remain humbling, with current approaches associated with overall poor results both in terms of local (30% of patients have local failure) and distant control (40% of patients have distant failure) with a median overall survival of 17 months.
This study is evaluating treatment with full dose chemotherapy and stereotactic body radiotherapy (SBRT). SBRT uses high doses of radiation in a very precise and conformal manner, the number of treatments are much reduced versus conventional radiation (SBRT would be able to be completed in 2 weeks or less). The biologically effective dose of SBRT is much higher than that of conventional radiation; despite being a shorter number of treatments the effective radiation dose is higher. SBRT would be completed in 2 weeks and since radiation would be completed in a shorter time span, would allow patients to have higher (systemic) chemotherapy doses.
The purpose of this study is to explore SBRT in addition to systemic doses of chemotherapy in the treatment of locally advanced NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Pemetrexed, Drug: Carboplatin, Drug: Cisplatin, Drug: Docetaxel, Drug: Paclitaxel, Radiation: stereotactic radiosurgeryChemotherapy: for Non-Squamous Cell: Pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 on day 1 of 21 day cycle or Carboplatin AUC6 and Paclitaxel 75 mg/m2 on day 1 of 21 day cycle for Squamous Cell: Cisplatin 75 mg/m2 and docetaxel 75mg m2 day 1 of 21 day cycle or Carboplatin AUC6 and paclitaxel 200 mg/m2 day 1 of 21 day cycle Radiation- Stereotactic radiosurgery Peripheral Lung lesion: 60 Gy over 3 fractions Central Lung lesion: 50 Gy over 5 fractions Hilar and Mediastinal LNs 40-50Gy over 5 fractions Schedule is: 2 cycles of chemotherapy, followed by SRS, followed by 2 additional cycles of chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Nonsmall cell lung cancer (NSCLC) (any histology)
- unresectable stage II
- Stage III
- Tumor less than 8 cm
- Karnofsky performance scale (KPS) of 50 or better
Key exclusion criteria (8 listed)
- Small cell lung cancer (SCLC)
- Stage I and stage IV patients
- Stage II patients eligible for surgical resection
- Concurrent severe disease that the treating physician feels will interfere with therapy this can include significant cardiovascular or pulmonary disease.
- KPS 40 or less (bed bound)
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 |
|---|---|---|
| PemetrexedAlso: Alimta | Drug | A |
| Carboplatin | Drug | A |
| Cisplatin | Drug | A |
| DocetaxelAlso: taxotere | Drug | A |
| PaclitaxelAlso: taxol | Drug | A |
| stereotactic radiosurgeryAlso: CK, cyberknife, cyber knife | Radiation | A |
Primary outcome
Disease free progression
Time frame: 4-6 months
Local control will be evaluated at end of treatment (4-6 months) and then at regular follow up intervals.
Toxicity (Treatment related side effects)
Time frame: 4-5 months
Treatment related side effects will be monitored
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
- Derived from this study: PubMed 35195562Kubicek GJ, Khrizman P, Squillante C, Callahan K, Xu Q, Abouzgheib W, Boujaoude Z, Patel A, Hageboutros A. Stereotactic Body Radiotherapy and Systemic Dose Chemotherapy for Locally Advanced Lung Cancer: Single Arm Phase 2 Study. Am J Clin Oncol. 2022 Mar 1;45(3):129-133. doi: 10.1097/COC.0000000000000892.
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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.
Kimberly Krieger contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Pemetrexed, Carboplatin and Cisplatin in people with Non Small Cell Lung Cancer, run by The Cooper Health System 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 6 inclusion and 8 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 31 Jan 2017. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Kimberly Krieger (856-735-6237), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free progression (time frame: 4-6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02568033, which also lists 1 linked publication.
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 31 Jan 2017.