Carcinoma, Non-Small-Cell LungPhase 2NCT00115518
Radiation Plus Cetuximab in Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
A Phase 2 study testing cetuximab in people with Carcinoma, Non-Small-Cell Lung, run by Heidelberg University at 1 site in Germany.
Trial summary
The purpose of this trial is to study combined locoregional radiotherapy with cetuximab in non-operable NSCLC Stage III (Phase II trial). Endpoints: safety and feasibility (primary) response, survival, time to progression (secondary) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- cetuximab
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- May 2005to Aug 2010
- Phase
- Phase 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
- Histologically verified NSCLC
- Not eligible for Radiochemotherapy or patient refuses chemotherapy
- FeV1 >1.5 L or min. 50%
- KPI >= 70%
- Life expectancy > 6 months
- Weight loss less than 10% of body weight in 12 months
Show all 10Show fewer
- Compliance
- Adequate blood counts (LC > 3000 x 10^3/ml, Tc >100000 x 10^3/ml, Hb > 10 g/dl)
- Effective contraception
- Amendment 1/07: FeV1 >1.2 L or min 40%
Who cannot join
- Active infection
- Reduced liver function
- Vena cava superior syndrome
- Malignant pleural effusion
- Pregnancy or breast feeding
- Additional serious systemic disease
Show all 10Show fewer
- Secondary malignancy (except carcinoma in situ of the cervix, basalioma of the skin, secondary cancer in remission for > 5 years)
- Known allergies against proteins
- History of former antibody therapy
- Allergy against i.v. contrast agents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Locoregional Radiotherapy in Combination With Cetuximab in Inoperable Non-Small Cell Lung Cancer Stage III
The purpose of this trial is to study combined locoregional radiotherapy with cetuximab in non-operable NSCLC Stage III (Phase II trial).
Endpoints:
safety and feasibility (primary) response, survival, time to progression (secondary)
Read the detailed description
Study entry examinations:
- blood cell count
- liver enzymes
- ventilatory function test
- pregnancy test (premenopausal women)
- CT of the thorax
- CT of the brain
- Ultrasound of the liver
- Bone scan
- FDG PET scan (after inclusion)
Follow-up examinations (2 months, than every 3 months):
- patients history and examination
- CT scan of the thorax
- ventilatory functions test
- FDG PET scan (at least at 6 months)
- bone scan (yearly)
- ultrasound of the liver (every 6 months)
Cetuximab administration:
- 450 mg / m^2 body surface on week 1
- 250 mg /m^2 body surface weekly, week 2 -21
Radiation therapy:
- intensity modulated radiation therapy of primary tumor and mediastinum (2 Gy single dose, total dose 50 Gy; 5 fractions per week) with boost to the PET positive sites (2 Gy single doses up to 66 Gy). Radiation therapy during weeks 2-8.
Amendment 1/07: 3D conformal RT possible, but not if FeV1 < 1.5L of < 50%
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- cetuximab
- 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.
cetuximabDrug
After Cetuximab loading dose. weekly cetuximab during RT. 13 weeks cetuximab weekly maintenance
What is being measured
The primary outcome is the main question the study is designed to answer.
safety: rate of side effects (skin reactions, allergic reactions, decrease of pulmonary function)
Measured: 3 yrs
Secondary outcomes (3)
response (RECIST criteria of primary tumor and enlarged lymphnodes)
Measured: 3 yrs
survival (at 3 years)
Measured: 3 yrs
time to progression (locally and systemically)
Measured: 3 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2005 (estimated)
- Study startMay 2005
- Primary completionJun 2009
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Investigators
- Klaus K Herfarth, MD, Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00115518
- Sponsor's protocol ID
- NEAR L-284/2004
- Status last verified
- Feb 2011
- First submitted
- 22 Jun 2005
- Last updated
- 5 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Jensen AD, Munter MW, Bischoff HG, Haselmann R, Haberkorn U, Huber PE, Thomas M, Debus J, Herfarth KK. Combined treatment of nonsmall cell lung cancer NSCLC stage III with intensity-modulated RT radiotherapy and cetuximab: the NEAR trial. Cancer. 2011 Jul 1;117(13):2986-94. doi: 10.1002/cncr.25888. Epub 2011 Jan 24.
PubMed 21264838Jensen AD, Munter MW, Bischoff H, Haselmann R, Timke C, Krempien R, Sterzing F, Nill S, Heeger S, Hoess A, Haberkorn U, Huber PE, Steins M, Thomas M, Debus J, Herfarth KK. Treatment of non-small cell lung cancer with intensity-modulated radiation therapy in combination with cetuximab: the NEAR protocol (NCT00115518). BMC Cancer. 2006 May 8;6:122. doi: 10.1186/1471-2407-6-122.
PubMed 16681848
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Locoregional Radiotherapy in Combination With Cetuximab in Inoperable Non-Small Cell Lung Cancer Stage III
- ClinicalTrials.gov ID
- NCT00115518
- Acronym / sponsor ID
- NEAR L-284/2004
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Jun 2009 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 23 Jun 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.
The purpose of this trial is to study combined locoregional radiotherapy with cetuximab in non-operable NSCLC Stage III (Phase II trial).
Endpoints:
safety and feasibility (primary) response, survival, time to progression (secondary)
Detailed description
Study entry examinations:
- blood cell count
- liver enzymes
- ventilatory function test
- pregnancy test (premenopausal women)
- CT of the thorax
- CT of the brain
- Ultrasound of the liver
- Bone scan
- FDG PET scan (after inclusion)
Follow-up examinations (2 months, than every 3 months):
- patients history and examination
- CT scan of the thorax
- ventilatory functions test
- FDG PET scan (at least at 6 months)
- bone scan (yearly)
- ultrasound of the liver (every 6 months)
Cetuximab administration:
- 450 mg / m^2 body surface on week 1
- 250 mg /m^2 body surface weekly, week 2 -21
Radiation therapy:
- intensity modulated radiation therapy of primary tumor and mediastinum (2 Gy single dose, total dose 50 Gy; 5 fractions per week) with boost to the PET positive sites (2 Gy single doses up to 66 Gy). Radiation therapy during weeks 2-8.
Amendment 1/07: 3D conformal RT possible, but not if FeV1 < 1.5L of < 50%
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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 (10 listed)
- Histologically verified NSCLC
- Not eligible for Radiochemotherapy or patient refuses chemotherapy
- FeV1 >1.5 L or min. 50%
- KPI >= 70%
- Life expectancy > 6 months
Key exclusion criteria (10 listed)
- Active infection
- Reduced liver function
- Vena cava superior syndrome
- Malignant pleural effusion
- Pregnancy or breast feeding
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 |
|---|---|---|
| cetuximabAfter Cetuximab loading dose. weekly cetuximab during RT. 13 weeks cetuximab weekly maintenance | Drug | – |
Primary outcome
safety: rate of side effects (skin reactions, allergic reactions, decrease of pulmonary function)
Time frame: 3 yrs
3 secondary outcomes
response (RECIST criteria of primary tumor and enlarged lymphnodes)
Time frame: 3 yrs
survival (at 3 years)
Time frame: 3 yrs
time to progression (locally and systemically)
Time frame: 3 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 5 Aug 2011.
- Results publication: PubMed 21264838Jensen AD, Munter MW, Bischoff HG, Haselmann R, Haberkorn U, Huber PE, Thomas M, Debus J, Herfarth KK. Combined treatment of nonsmall cell lung cancer NSCLC stage III with intensity-modulated RT radiotherapy and cetuximab: the NEAR trial. Cancer. 2011 Jul 1;117(13):2986-94. doi: 10.1002/cncr.25888. Epub 2011 Jan 24.
- Derived from this study: PubMed 16681848Jensen AD, Munter MW, Bischoff H, Haselmann R, Timke C, Krempien R, Sterzing F, Nill S, Heeger S, Hoess A, Haberkorn U, Huber PE, Steins M, Thomas M, Debus J, Herfarth KK. Treatment of non-small cell lung cancer with intensity-modulated radiation therapy in combination with cetuximab: the NEAR protocol (NCT00115518). BMC Cancer. 2006 May 8;6:122. doi: 10.1186/1471-2407-6-122.
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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.
Klaus K Herfarth, MD principal investigator
Heidelberg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cetuximab in people with Carcinoma, Non-Small-Cell Lung, run by Heidelberg University at 1 site in Germany.
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 10 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 5 Aug 2011. 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 Germany. 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 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?
safety: rate of side effects (skin reactions, allergic reactions, decrease of pulmonary function) (time frame: 3 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 NCT00115518, which also lists 2 linked publications.
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 5 Aug 2011.