Inoperable Locally Advanced Non Small Cell Lung CancerPhase 1N12HYBNCT01933568
Combined CFRT and SABR in Stage II and III NSCLC With Peripheral Tumors Smaller Than 5 cm.
A Phase 1 study testing SABR and Cisplatin in people with Inoperable Locally Advanced Non Small Cell Lung Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial summary
A phase I trial is being conducted in patients with inoperable locally advanced NSCLC to treat with a combination of Conventional Fractionated Radiotherapy (CFRT) on the mediastinal lymph nodes and Stereotactic Ablative Radiotherapy (SABR)on the primary tumor with concurrent chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inoperable Locally Advanced Non Small Cell Lung Cancer
- What is being tested?
- SABR and Cisplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Feb 2013to 11 Nov 2018
- Phase
- 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
- Cytological or histological proven NSCLC stage III or inoperable stage II, cT1-2a-3N1-3M0 with peripheral tumors < 5 cm (chest wall infiltration is no exclusion criteria if the tumor diameter is < 5 cm).
- Weight loss < 10% in the last three months
- WHO-performance status ≤ 2
- Patients that receive concurrent chemoradiotherapy, with the exception of adriamycin and gemcitabine
- FEV1 and DLCO > 40 % of the age-adjusted normal value
- Minimum required laboratory data bone marrow reserve and hepatic- and renal function
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Before patient registration, written informed consent must be given according to GCP and national regulations
Who cannot join
- Patients with central tumors < 2 cm of the proximal bronchial tree (Figure 2) or tumors immediately adjacent to mediastinal or pericardial pleura.
- Patients that receive sequential chemoradiotherapy or radiotherapy only.
- Patients with grade 3 dyspnea at baseline (according to CTCAE version 4.03)
- Patients with Pancoast tumors
- Prior radiotherapy treatment to the thorax
- Any contraindications to the administration of thoracic radiotherapy
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Stereotactic Radiotherapy and Conventional Fractionation in Stage II and III Non Small Cell Lung Cancer (NSCLC) With Peripheral Tumors Smaller Than 5 cm
A phase I trial is being conducted in patients with inoperable locally advanced NSCLC to treat with a combination of Conventional Fractionated Radiotherapy (CFRT) on the mediastinal lymph nodes and Stereotactic Ablative Radiotherapy (SABR)on the primary tumor with concurrent chemotherapy. It is hypothesized that this will lead to an increase of local control and overall survival
Read the detailed description
In locally advanced NSCLC local control has been poor, but with SABR remarkable high local control rates with low toxicity have been reported. Currently stage III and inoperable II NSCLC patients have been treated with IMRT and concurrent chemotherapy at out institute. In this study we will explore the combination of SABR and CFRT with concurrent chemotherapy
- Being tested
- SABR, Cisplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SABRRadiation
combined CFRT and SABR with concurrent cisplatin
CisplatinDrug
combined CFRT and SABR with concurrent cisplatin
| Study group | Role | What they receive |
|---|---|---|
| Radiation | Experimental | combined CFRT and SABR with concurrent cisplatin Receives: Radiation: SABR; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean-lung dose that is associated with a 15% probability of dose limiting toxicity, defined according to the CTCAE v4; radiation pneumonitis ≥ grade 3 and radiation induced dyspnea ≥ grade 3.
Measured: 2 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2013 (estimated)
- Study start28 Feb 2013
- Primary completion11 Nov 2018
- Study completion11 Nov 2018
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 Inoperable Locally Advanced Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heike Peulen, MD, Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01933568
- Sponsor's protocol ID
- N12HYB
- Acronym
- N12HYB
- Status last verified
- Jun 2019
- First submitted
- 28 Aug 2013
- Last updated
- 27 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Peulen H, Franssen G, Belderbos J, van der Bijl E, Tijhuis A, Rossi M, Sonke JJ, Damen E. SBRT combined with concurrent chemoradiation in stage III NSCLC: Feasibility study of the phase I Hybrid trial. Radiother Oncol. 2020 Jan;142:224-229. doi: 10.1016/j.radonc.2019.07.015. Epub 2019 Aug 17.
PubMed 31431387
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Stereotactic Radiotherapy and Conventional Fractionation in Stage II and III Non Small Cell Lung Cancer (NSCLC) With Peripheral Tumors Smaller Than 5 cm
- ClinicalTrials.gov ID
- NCT01933568
- Acronym / sponsor ID
- N12HYB / N12HYB
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- 28 Feb 2013 (actual)
- Primary completion
- 11 Nov 2018 (actual)
- Study completion
- 11 Nov 2018 (actual)
- First posted
- 2 Sep 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.
A phase I trial is being conducted in patients with inoperable locally advanced NSCLC to treat with a combination of Conventional Fractionated Radiotherapy (CFRT) on the mediastinal lymph nodes and Stereotactic Ablative Radiotherapy (SABR)on the primary tumor with concurrent chemotherapy. It is hypothesized that this will lead to an increase of local control and overall survival
Detailed description
In locally advanced NSCLC local control has been poor, but with SABR remarkable high local control rates with low toxicity have been reported. Currently stage III and inoperable II NSCLC patients have been treated with IMRT and concurrent chemotherapy at out institute. In this study we will explore the combination of SABR and CFRT with concurrent chemotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation | Experimental | Radiation: SABR, Drug: Cisplatincombined CFRT and SABR with concurrent cisplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Cytological or histological proven NSCLC stage III or inoperable stage II, cT1-2a-3N1-3M0 with peripheral tumors < 5 cm (chest wall infiltration is no exclusion criteria if the tumor diameter is < 5 cm).
- Weight loss < 10% in the last three months
- WHO-performance status ≤ 2
- Patients that receive concurrent chemoradiotherapy, with the exception of adriamycin and gemcitabine
- FEV1 and DLCO > 40 % of the age-adjusted normal value
Key exclusion criteria (7 listed)
- Patients with central tumors < 2 cm of the proximal bronchial tree (Figure 2) or tumors immediately adjacent to mediastinal or pericardial pleura.
- Patients that receive sequential chemoradiotherapy or radiotherapy only.
- Patients with grade 3 dyspnea at baseline (according to CTCAE version 4.03)
- Patients with Pancoast tumors
- Prior radiotherapy treatment to the thorax
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 |
|---|---|---|
| SABRcombined CFRT and SABR with concurrent cisplatin | Radiation | Radiation |
| Cisplatincombined CFRT and SABR with concurrent cisplatin | Drug | Radiation |
Primary outcome
The mean-lung dose that is associated with a 15% probability of dose limiting toxicity, defined according to the CTCAE v4; radiation pneumonitis ≥ grade 3 and radiation induced dyspnea ≥ grade 3.
Time frame: 2 yrs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
- Derived from this study: PubMed 31431387Peulen H, Franssen G, Belderbos J, van der Bijl E, Tijhuis A, Rossi M, Sonke JJ, Damen E. SBRT combined with concurrent chemoradiation in stage III NSCLC: Feasibility study of the phase I Hybrid trial. Radiother Oncol. 2020 Jan;142:224-229. doi: 10.1016/j.radonc.2019.07.015. Epub 2019 Aug 17.
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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.
Heike Peulen, MD principal investigator
The Netherlands Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SABR and Cisplatin in people with Inoperable Locally Advanced Non Small Cell Lung Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
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 8 inclusion and 7 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: finished, as of the sponsor's last update on 27 Jun 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 Netherlands. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The mean-lung dose that is associated with a 15% probability of dose limiting toxicity, defined according to the CTCAE v4; radiation pneumonitis ≥ grade 3 and radiation induced dyspnea ≥ grade 3. (time frame: 2 yrs). 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 NCT01933568, 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 27 Jun 2019.