Non-Small-Cell Lung CarcinomaPhase 1/2NCT00181506
HI-CHART:Feasibility of High-Dose Accelerated Conformal Radiotherapy
A Phase 1/2 study testing dose escalation (radiotherapy treatment schedule) in people with Non-Small-Cell Lung Carcinoma, run by Maastricht Radiation Oncology at 1 site in Netherlands.
Trial summary
In this study we try to increase the radiation dose, while reducing or keeping the radiation schedule below 4 weeks. The study hypothesis is that it is feasible to administer hyperfractionated accelerated radiotherapy to patients with inoperable or locally advanced non small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small-Cell Lung Carcinoma
- What is being tested?
- dose escalation (radiotherapy treatment schedule)
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2001to Dec 2007
- 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
- histological or cytological diagnosis of non-small cell lung cancer stage I-III disease, except supra-clavicular lymph nodes availability for participating in the detailed follow-up of the protocol able to tolerate a radiation course according to the protocol guidelines in case of previous chemotherapy, radiotherapy can start after a minimum of 3 weeks after the last CT course good performance status: Karnofsky>=70%, WHO performance status 0-2 adequate lung functions allowing the radiation according to the guidelines protocol no severe recent cardiac disease absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; conditions should be discussed with the patient before registration in the trial -
Who cannot join
- patients who have a peripherally located lower lobe tumor and contralateral upper mediastinal nodes malignant pleural or pericardial effusion concurrent chemotherapy programs history of a prior malignancy excluding non melanoma skin cancer or in-situ cancer history of prior chest irradiation recent myocardial infraction uncontrolled infectious disease distant metastases (stage IV)
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HI-CHART: A Phase I/II Study on the Feasibility of High-Dose Accelerated Conformal Radiotherapy in Patients With Inoperable Non-Small Cell Lung Cancer.
In this study we try to increase the radiation dose, while reducing or keeping the radiation schedule below 4 weeks.
The study hypothesis is that it is feasible to administer hyperfractionated accelerated radiotherapy to patients with inoperable or locally advanced non small cell lung cancer.
Read the detailed description
Non-small cell lung cancer is still the most common cancer and the main cause of cancer death. Treatment of choice for these patients is often radiotherapy, which results in an overall 5-year survival rate between 5 and 10%. The addition of chemotherapy improves survival by a few percentages and is therefore considered standard treatment for patients with stage III disease.
However, several factors have been identified that have an impact on the local control but also on survival.
- There is a dose-effect relationship. A higher dose results in a better survival rate. However, higher radiation doses are currently not delivered with conventional radiation due to the tolerance of normal tissue.
- The time factor plays an important role in radiotherapy. Prolonging the overall treatment time decreases the outcome of radiotherapy. Radiobiological modelling of data shows that the overall treatmetn time (OTT) should be kept below 4 weeks. Results from studies support this conclusion.
So, probably the best results will be achieved when a very high radiation dose can be delivered within 4 weeks, without severally damaging normal tissue.
In order to achieve this goal, an hyperfractionated accelerated treatment regimen together with a technically very advanced radiation technique to avoid as much normal tissue as possible, will be used in this study.
- Conditions
- Non-Small-Cell Lung Carcinoma
- Being tested
- dose escalation (radiotherapy treatment schedule)
- Keywords
- radiotherapy, radiation dose, lung cancer
- 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.
dose escalation (radiotherapy treatment schedule)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
acute toxicity
Secondary outcomes (1)
late toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startDec 2001
- Primary completionDec 2007
- Study completionDec 2007
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.
- 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
- 180 participants
Sponsor and investigators
- Lead sponsor
- Maastricht Radiation Oncology
- Sponsor type
- University, hospital or other
- Investigators
- Rinus Wanders, MD, Principal investigator, Maastricht Radiation Oncology (MAASTRO clinic)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00181506
- Sponsor's protocol ID
- P01.1314L
- Other IDs
- MEC MAASTRO clinic: 0105
- Status last verified
- Jun 2009
- First submitted
- 13 Sep 2005
- Last updated
- 30 Jun 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HI-CHART: A Phase I/II Study on the Feasibility of High-Dose Accelerated Conformal Radiotherapy in Patients With Inoperable Non-Small Cell Lung Cancer.
- ClinicalTrials.gov ID
- NCT00181506
- Acronym / sponsor ID
- P01.1314L
- Conditions
- Non-Small-Cell Lung Carcinoma
- Keywords
- radiotherapy, radiation dose, lung cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants
- Lead sponsor
- Maastricht Radiation OncologyUniversity, hospital or other
- Study start
- Dec 2001
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 16 Sep 2005 (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.
In this study we try to increase the radiation dose, while reducing or keeping the radiation schedule below 4 weeks.
The study hypothesis is that it is feasible to administer hyperfractionated accelerated radiotherapy to patients with inoperable or locally advanced non small cell lung cancer.
Detailed description
Non-small cell lung cancer is still the most common cancer and the main cause of cancer death. Treatment of choice for these patients is often radiotherapy, which results in an overall 5-year survival rate between 5 and 10%. The addition of chemotherapy improves survival by a few percentages and is therefore considered standard treatment for patients with stage III disease.
However, several factors have been identified that have an impact on the local control but also on survival.
- There is a dose-effect relationship. A higher dose results in a better survival rate. However, higher radiation doses are currently not delivered with conventional radiation due to the tolerance of normal tissue.
- The time factor plays an important role in radiotherapy. Prolonging the overall treatment time decreases the outcome of radiotherapy. Radiobiological modelling of data shows that the overall treatmetn time (OTT) should be kept below 4 weeks. Results from studies support this conclusion.
So, probably the best results will be achieved when a very high radiation dose can be delivered within 4 weeks, without severally damaging normal tissue.
In order to achieve this goal, an hyperfractionated accelerated treatment regimen together with a technically very advanced radiation technique to avoid as much normal tissue as possible, will be used in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- histological or cytological diagnosis of non-small cell lung cancer stage I-III disease, except supra-clavicular lymph nodes availability for participating in the detailed follow-up of the protocol able to tolerate a radiation course according to the protocol guidelines in case of previous chemotherapy, radiotherapy can start after a minimum of 3 weeks after the last CT course good performance status: Karnofsky>=70%, WHO performance status 0-2 adequate lung functions allowing the radiation according to the guidelines protocol no severe recent cardiac disease absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; conditions should be discussed with the patient before registration in the trial -
Key exclusion criteria (2 listed)
- patients who have a peripherally located lower lobe tumor and contralateral upper mediastinal nodes malignant pleural or pericardial effusion concurrent chemotherapy programs history of a prior malignancy excluding non melanoma skin cancer or in-situ cancer history of prior chest irradiation recent myocardial infraction uncontrolled infectious disease distant metastases (stage IV)
- -
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 |
|---|---|---|
| dose escalation (radiotherapy treatment schedule) | Procedure or surgery | – |
Primary outcome
acute toxicity
1 secondary outcome
late toxicity
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 30 Jun 2009.
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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.
Rinus Wanders, MD principal investigator
Maastricht Radiation Oncology (MAASTRO clinic)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing dose escalation (radiotherapy treatment schedule) in people with Non-Small-Cell Lung Carcinoma, run by Maastricht Radiation Oncology 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 1 inclusion and 2 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 30 Jun 2009. 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 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?
acute toxicity. 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 30 Jun 2009.