Non-small-cell Lung CarcinomaGFPC_01-14NCT02400424
Study of the Efficacy of SBRT on Unresectable Peripheral Primary Tumor
A study testing SBRT in people with Non-small-cell Lung Carcinoma, run by Centre Leon Berard at 2 sites in France.
Trial summary
The purpose of this study is to evaluate the efficacy of stereotactic lung radiation therapy after concomitant radiochemotherapy for unresectable stage III non-small cell lung carcinoma (NSCLC) with peripheral primary tumor. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small-cell Lung Carcinoma
- What is being tested?
- SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesFrance
- Study dates
- Feb 2015to 25 Jun 2020
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years ≤ Age ≤ 75 years
- PS ECOG 0 or 1
- Histologically proven NSCLC
- Unresectable stage III: T1 or T2 or T3 ≤ 5 cm AND N2 or N3 (only contralateral mediastinum or homolateral supraclavicular).
- Peripheral primary tumor ≥ 1 cm and ≤ 5 cm
- Possible concomitant chemoradiotherapy : 1 cure induction and 3 concomitant cycles of chemotherapy with cisplatin and Navelbine ® and 3D conformal radiotherapy delivering 66 Gy in 33 fractions to the mediastinal lymph node involvement without treating the peripheral tumor.
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- Adequate biological parameters
- Forced expiratory volume (FEV) ≥1 liter or ≥ 30% of the theoretical value
- Patient covered by a health insurance scheme
- Signed informed consent
Who cannot join
- SCLC or large cell neuroendocrine carcinoma
- Metastatic disease
- Stage IVa
- Pregnant or breast-feeding women
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Leon Berard
Lyon, 69373 cedex 08
Hopital Nord-Ouest
Villefranche, 69655
About this study
Official title: Multicenter Prospective Study of the Efficacy of Stereotactic Lung Radiation Therapy After Concomitant Radio-chemotherapy for Unresectable Stage III Non-small Cell Lung Carcinoma (NSCLC) With Peripheral Primary Tumor.
The purpose of this study is to evaluate the efficacy of stereotactic lung radiation therapy after concomitant radiochemotherapy for unresectable stage III non-small cell lung carcinoma (NSCLC) with peripheral primary tumor.
Evaluate in terms of local control rate at 6 months the addition of stereotactic radiotherapy after concurrent chemoradiotherapy in the treatment of mediastinal non-resectable stage III NSCLC having a peripheral primary tumor.
The number of patients required in this multicenter prospective study is 70.
This is a prospective, multicenter, non comparative and non randomized study.
Read the detailed description
Stereotactic radiotherapy or SBRT (Body Stereotactic Radiation Therapy) allows to irradiate with high dose limited lesions size with a local control surrounding of 80-98% and with a low level of toxicity.
We propose to realize a classic concomitant RT-CT for mediastinal irradiation and combine this treatment with stereotactic RT for peripheral primary tumor.
The estimated inclusion period is approximately 3 years.
Follow-up duration for each patient is 2 years. The duration of the research is 5 years.
- Conditions
- Non-small-cell Lung Carcinoma
- Being tested
- SBRT
- Keywords
- Stereotactic lung radiation therapy, Radiochemotherapy, Unresectable stage III Non-Small Cell lung Carcinoma, Peripheral primary tumor
- 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.
SBRTRadiation
Also called Stereotactic body radiation therapy
54 Gy in 3 fractions D1-D3-D5. SBRT should be started within 3 to 4 weeks after the end of radiochemotheray (RT-CT).
| Study group | Role | What they receive |
|---|---|---|
| SBRT | Experimental | Study treatment = SBRT for peripheral primary tumor. Receives: Radiation: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local control rate
According to RECIST v1.1
Measured: 6 months after the end of SBRT
Secondary outcomes (3)
Overall survival
Measured: From date of inclusion until the date of death from any cause, assessed up to 24 months after the end of SBRT
Progression-free survival
Measured: From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months after the end of SBRT
Safety (adverse events, assessed using the NCI-CTCAE v4 grading scale)
Incidence of adverse events, assessed using the NCI-CTCAE v4 grading scale
Measured: Up to 2 years after the end of SBRT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completion13 Feb 2019
- Study completion25 Jun 2020
Why it stopped: Approval of adjuvant durvalumab after RT-CT (not anticipated in the study design) and small number of stage III NSLCL patients with peripheral tumor accessible to SBRT
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 CarcinomaStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle IM Martel Lafay, MD, Principal investigator, Center Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02400424
- Sponsor's protocol ID
- GFPC 01-14
- Acronym
- GFPC_01-14
- Status last verified
- Feb 2021
- First submitted
- 11 Mar 2015
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Study of the Efficacy of Stereotactic Lung Radiation Therapy After Concomitant Radio-chemotherapy for Unresectable Stage III Non-small Cell Lung Carcinoma (NSCLC) With Peripheral Primary Tumor.
- ClinicalTrials.gov ID
- NCT02400424
- Acronym / sponsor ID
- GFPC_01-14 / GFPC 01-14
- Conditions
- Non-small-cell Lung Carcinoma
- Keywords
- Stereotactic lung radiation therapy, Radiochemotherapy, Unresectable stage III Non-Small Cell lung Carcinoma, Peripheral primary tumor
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Approval of adjuvant durvalumab after RT-CT (not anticipated in the study design) and small number of stage III NSLCL patients with peripheral tumor accessible to SBRT
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- 13 Feb 2019 (actual)
- Study completion
- 25 Jun 2020 (actual)
- First posted
- 27 Mar 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.
The purpose of this study is to evaluate the efficacy of stereotactic lung radiation therapy after concomitant radiochemotherapy for unresectable stage III non-small cell lung carcinoma (NSCLC) with peripheral primary tumor.
Evaluate in terms of local control rate at 6 months the addition of stereotactic radiotherapy after concurrent chemoradiotherapy in the treatment of mediastinal non-resectable stage III NSCLC having a peripheral primary tumor.
The number of patients required in this multicenter prospective study is 70.
This is a prospective, multicenter, non comparative and non randomized study.
Detailed description
Stereotactic radiotherapy or SBRT (Body Stereotactic Radiation Therapy) allows to irradiate with high dose limited lesions size with a local control surrounding of 80-98% and with a low level of toxicity.
We propose to realize a classic concomitant RT-CT for mediastinal irradiation and combine this treatment with stereotactic RT for peripheral primary tumor.
The estimated inclusion period is approximately 3 years.
Follow-up duration for each patient is 2 years. The duration of the research is 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT | Experimental | Radiation: SBRTStudy treatment = SBRT for peripheral primary tumor. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 years ≤ Age ≤ 75 years
- PS ECOG 0 or 1
- Histologically proven NSCLC
- Unresectable stage III: T1 or T2 or T3 ≤ 5 cm AND N2 or N3 (only contralateral mediastinum or homolateral supraclavicular).
- Peripheral primary tumor ≥ 1 cm and ≤ 5 cm
Key exclusion criteria (4 listed)
- SCLC or large cell neuroendocrine carcinoma
- Metastatic disease
- Stage IVa
- Pregnant or breast-feeding women
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 |
|---|---|---|
| SBRTAlso: Stereotactic body radiation therapy54 Gy in 3 fractions D1-D3-D5. SBRT should be started within 3 to 4 weeks after the end of radiochemotheray (RT-CT). | Radiation | SBRT |
Primary outcome
Local control rate
Time frame: 6 months after the end of SBRT
According to RECIST v1.1
3 secondary outcomes
Overall survival
Time frame: From date of inclusion until the date of death from any cause, assessed up to 24 months after the end of SBRT
Progression-free survival
Time frame: From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months after the end of SBRT
Safety (adverse events, assessed using the NCI-CTCAE v4 grading scale)
Time frame: Up to 2 years after the end of SBRT
Results and safety
The study was stopped early (reason given: Approval of adjuvant durvalumab after RT-CT (not anticipated in the study design) and small number of stage III NSLCL patients with peripheral tumor accessible to SBRT). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
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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.
Isabelle IM Martel Lafay, MD principal investigator
Center Leon Berard
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBRT in people with Non-small-cell Lung Carcinoma, run by Centre Leon Berard at 2 sites in France.
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 10 inclusion and 4 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 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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.
Are results available for this study?
The study was stopped early (reason given: Approval of adjuvant durvalumab after RT-CT (not anticipated in the study design) and small number of stage III NSLCL patients with peripheral tumor accessible to SBRT). 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?
Local control rate (time frame: 6 months after the end of SBRT). 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 9 Feb 2021.