Lung CancerPhase 1/2VOLUMESNCT01543672
Irradiation of Large Lung Tumors or Two or More Lung Metastases Simultaneously
A Phase 1/2 study testing Stereotactic Body Radiotherapy (SBRT) in people with Lung Cancer and Metastatic Lung Cancer, run by The Netherlands Cancer Institute at 5 sites in 4 countries.
Trial summary
Treatment of larger tumor volumes or ≥ 2 lung metastases simultaneously in lung cancer patient using Stereotactic Body Radiation Therapy (SBRT) in a mean-lung dose escalation study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Metastatic Lung Cancer
- What is being tested?
- Stereotactic Body Radiotherapy (SBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 22 Nov 2011to 31 Oct 2017
- Phase
- Phase 1/2
- 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
- Weight loss < 10% in the last three months.
- WHO-performance status ≤ 2
- Medical inoperable patients or patients refusing surgery.
- Chemotherapy is allowed in neoadjuvant and adjuvant setting, with exclusion of the period 4 weeks pre-SBRT and 6 weeks post-SBRT.
- Before patient registration, written informed consent must be given according to ICH/GCP, national and local regulations.
- Risk group A specification:
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- NSCLC (Cytological or histological proven) patients with peripheral tumors >5 cm with tumor staging cT2bN0M0 or cT3N0M0 (chest wall infiltration is no exclusion criteria, as long as the tumor diameter is > 5 cm).
- Single peripheral lung metastasis in inoperable patients with a diameter of > 5 cm. In case of first presentation of metastatic disease, cytological or histological proof is obligated.
- In patients without cytological or histological confirmation of NSCLC, a growing FDG-PET positive lesion (SUV >5) is accepted if a contra-indication for invasive diagnostic examination (or refusal) is present.
- Risk group B specification:
- Patients with ≥ 2 simultaneous peripheral lung metastases ≤ 5 cm of any origin at any location in the lung.
- In case of first presentation of metastatic disease, cytological or histological proof is obligated. This is not necessary in case of a history of an already proven disseminated disease.
- Patients having ≥ 2 peripheral lung metastases without unacceptable dose overlap.
Who cannot join
- Patients with central tumors
- Pancoast tumors
- Prior radiotherapy treatment to the thorax
- Patients receiving any systemic treatment during SBRT
- Pregnant patients
- Patients previously treated with adriamycin agents in case of heart involvement within the treatment field.
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
United States2 sites
Thomas Jefferson University/ Kimmel Cancer Center
Philadelphia, Pennsylvania, PA 19107
Beaumont Hospital, Royal Oak
Royal Oak, Michigan, 48076
About this study
Official title: VOLUMES Treatment of Larger Tumor Volumes or ≥ 2 Lung Tumors Simultaneously in Lung Cancer Patients Using SBRT in a Mean-lung Dose Escalation Study
Treatment of larger tumor volumes or ≥ 2 lung metastases simultaneously in lung cancer patient using Stereotactic Body Radiation Therapy (SBRT) in a mean-lung dose escalation study.
Read the detailed description
A phase I/II multicenter trial will be conducted in patients with medically inoperable with peripheral non small cell lung cancer (NSCLC) > 5 cm without lymph node involvement (group A) or medically with ≥ 2 or more lung metastases (group B). Radiation pneumonitis is expected to be dose-limiting in these patients and there is evidence that the incidence is predicted by the mean lung dose (MLD). The MLD escalation will be performed separately in both patient groups, using a time-to-event continual reassessment method (TITE-CRM). All patients will receive 3-5 fractions SBRT to the lung tumor(s), with a minimum mean PTV dose ≥ 42 Gy. Fraction size may be downscaled based on the MLD constraint.
- Conditions
- Lung Cancer, Metastatic Lung Cancer
- Being tested
- Stereotactic Body Radiotherapy (SBRT)
- Keywords
- lung, SBRT, MLD, toxicity
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiotherapy (SBRT)Radiation
Also called Stereotactic Body Radiotherapy
3-5 fractions within 10-14 days
Stereotactic Body Radiotherapy (SBRT)Radiation
Also called Stereotactic Body Radiotherapy
3-5 fractions per tumor within one treatment session or sequential within one month
| Study group | Role | What they receive |
|---|---|---|
| SBRT group A | Experimental | escalate MLD in medically inoperable patients with tumors larger than 5 cm in diameter (primary or solitary metastases) Receives: Radiation: Stereotactic Body Radiotherapy (SBRT) |
| SBRT group B | Experimental | Escalate the MLD in patients with ≥ 2 lung metastases Receives: Radiation: Stereotactic Body Radiotherapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
MLD
The assessment of the maximum mean lung dose that can be safely treated with SBRT and that is associated with a 20% probability of the DLT.
Measured: 4 years
Secondary outcomes (3)
loco-regional control
Determine the local control and regional control as a function of the mean lung dose, the largest toxicity effects as a function of the MLD and the overall survival.
Measured: 4 years
overall survival
Determine the local control and regional control as a function of the mean lung dose, the largest toxicity effects as a function of the MLD and the overall survival.
Measured: 5 years
Quality of life assessment
valuate the increase or decrease of physical discomfort.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study start22 Nov 2011
- Primary completion31 Oct 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 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
- NCT01543672
- Sponsor's protocol ID
- M11VOL
- Acronym
- VOLUMES
- Status last verified
- Oct 2017
- First submitted
- 21 Feb 2012
- Last updated
- 27 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- VOLUMES Treatment of Larger Tumor Volumes or ≥ 2 Lung Tumors Simultaneously in Lung Cancer Patients Using SBRT in a Mean-lung Dose Escalation Study
- ClinicalTrials.gov ID
- NCT01543672
- Acronym / sponsor ID
- VOLUMES / M11VOL
- Conditions
- Lung Cancer, Metastatic Lung Cancer
- Keywords
- lung, SBRT, MLD, toxicity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- 22 Nov 2011 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 5 Mar 2012 (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.
Treatment of larger tumor volumes or ≥ 2 lung metastases simultaneously in lung cancer patient using Stereotactic Body Radiation Therapy (SBRT) in a mean-lung dose escalation study.
Detailed description
A phase I/II multicenter trial will be conducted in patients with medically inoperable with peripheral non small cell lung cancer (NSCLC) > 5 cm without lymph node involvement (group A) or medically with ≥ 2 or more lung metastases (group B). Radiation pneumonitis is expected to be dose-limiting in these patients and there is evidence that the incidence is predicted by the mean lung dose (MLD). The MLD escalation will be performed separately in both patient groups, using a time-to-event continual reassessment method (TITE-CRM). All patients will receive 3-5 fractions SBRT to the lung tumor(s), with a minimum mean PTV dose ≥ 42 Gy. Fraction size may be downscaled based on the MLD constraint.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SBRT group A | Experimental | Radiation: Stereotactic Body Radiotherapy (SBRT)escalate MLD in medically inoperable patients with tumors larger than 5 cm in diameter (primary or solitary metastases) |
| SBRT group B | Experimental | Radiation: Stereotactic Body Radiotherapy (SBRT)Escalate the MLD in patients with ≥ 2 lung metastases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Weight loss < 10% in the last three months.
- WHO-performance status ≤ 2
- Medical inoperable patients or patients refusing surgery.
- Chemotherapy is allowed in neoadjuvant and adjuvant setting, with exclusion of the period 4 weeks pre-SBRT and 6 weeks post-SBRT.
- Before patient registration, written informed consent must be given according to ICH/GCP, national and local regulations.
Key exclusion criteria (6 listed)
- Patients with central tumors
- Pancoast tumors
- Prior radiotherapy treatment to the thorax
- Patients receiving any systemic treatment during SBRT
- Pregnant patients
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 |
|---|---|---|
| Stereotactic Body Radiotherapy (SBRT)Also: Stereotactic Body Radiotherapy3-5 fractions within 10-14 days | Radiation | SBRT group A |
| Stereotactic Body Radiotherapy (SBRT)Also: Stereotactic Body Radiotherapy3-5 fractions per tumor within one treatment session or sequential within one month | Radiation | SBRT group B |
Primary outcome
MLD
Time frame: 4 years
The assessment of the maximum mean lung dose that can be safely treated with SBRT and that is associated with a 20% probability of the DLT.
3 secondary outcomes
loco-regional control
Time frame: 4 years
overall survival
Time frame: 5 years
Quality of life assessment
Time frame: 2 years
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.
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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
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Stereotactic Body Radiotherapy (SBRT) in people with Lung Cancer and Metastatic Lung Cancer, run by The Netherlands Cancer Institute at 5 sites in 4 countries.
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 13 inclusion and 6 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 5 sites in United States, Canada, Germany, 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 combined 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.
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 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?
MLD (time frame: 4 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 27 Jun 2019.