Non-Small Cell Lung CancerPhase 3CYCLUSNCT00300729
Effect of Celecoxib on Survival in Patients With Advanced Non-Small Cell Lung Cancer Receiving Chemotherapy
A Phase 3 study testing Celecoxib in people with Non-Small Cell Lung Cancer, run by University Hospital, Linkoeping at 13 sites in Sweden.
Trial summary
The primary purpose of the study is to investigate if daily treatment with celecoxib, an inhibitor of cyclooxygenase-2, can prolong survival in patients with advanced non-small cell lung cancer who receive anticancer chemotherapy as their primary treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Celecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 319 participants
- Where
- 13 sitesSweden
- Study dates
- May 2006to Sep 2010
- Phase
- Phase 3
- 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 or cytologically confirmed non-small cell lung cancer (NSCLC).
- Age at least 18 years. No upper age limit.
- Disease stage IIIB or IV.
- Performance status (WHO) 0-2
- Treatment with curative intent is not possible
- No prior chemotherapy for the present disease
Show all 11Show fewer
- Planned treatment is palliative chemotherapy
- WBC count at least 3.0, platelet count at least 100
- Bilirubin < 1.5 * upper reference limit (URL), ASAT and ALAT < 3 * URL (<5 in case of liver metastases)
- Calculated creatinine clearance at least 40 mg/ml
- Informed oral and written consent
Who cannot join
- Regular use of NSAID (except ASA at a dose of 50-100 mg daily)
- Active duodenal ulcer, ongoing gastrointestinal bleeding or inflammatory bowel disease
- Serious heart failure or serious liver disease
- Hypersensitivity so sulfonamides
- Pregnancy
- Lactation
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Sweden13 sites
Department of Pulmonary Medicine and Allergology, Sahlgrenska University Hospital
Gothenburg, 413 45
Section of Pulmonary Medicine, Ryhov County Hospital
Jönköping, 551 85
Section of Pulmonary Medicine and Allergology, County Hospital of Kalmar
Kalmar, 391 85
Department of Pulmonary Medicine, University Hospital
Linköping, 581 85
Department of Pulmonary Medicine and Allergy, Lund University Hospital
Lund, 221 85
Section of Pulmonary Medicine, Malmö University Hospital
Malmö, 205 02
Department of Pulmonary Medicine, Örebro University Hospital
Örebro, 701 85
Department of Medicine, Skövde Hospital/KSS
Skövde, 541 85
Department of Medicine, Trollhättan Hospital/NÄL
Trollhättan, 461 85
Department of Medicine, Uddevalla Hospital
Uddevalla, 451 80
Department of Pulmonary medicine, Umeå University Hospital
Umeå, 901 85
Department of Pulmonary Medicine and Allergology, Uppsala University Hospital
Uppsala, 751 85
Department of Medicine, Ystad Hospital
Ystad, SE-27182
About this study
Official title: Cox-2-Inhibitor and Chemotherapy in Non-Small Cell Lung Cancer. A Prospective Randomized Double-Blind Study
The primary purpose of the study is to investigate if daily treatment with celecoxib, an inhibitor of cyclooxygenase-2, can prolong survival in patients with advanced non-small cell lung cancer who receive anticancer chemotherapy as their primary treatment. Secondary endpoints of the study are: health-related quality of life, toxicity, cardiovascular events, progression-free survival, and biological markers (VEGF, proteomics).
Read the detailed description
The study (CYCLUS trial, CY-cyclooxygenase-2 inhibitor, Chemotherapy, LUng cancer, Survival) is a prospective randomized double-blind multicenter trial. Patients are randomized to receive celecoxib at a dose of 400 mg b.i.d. or placebo. Primary endpoint of the trial is survival. Secondary endpoints are: quality of life, progression-free survival, toxicity, cardiovascular events, and biological parameters (plasma VEGF and proteomics).
The rationale behind the study consists of preclinical observations of antitumor effect of celecoxib in NSCLC. Inhibition of angiogenesis and proliferation as well as increased apoptosis has been demonstrated. In addition, pilot studies have shown that the combination of chemotherapy and celecoxib is feasible. No unexpected toxicity has been recorded in such trials. Furthermore, a randomized study of indomethacin, prednisolone or placebo in other types of advanced cancer, mainly gastrointestinal, showed a survival advantage for patients receiving antiinflammatory treatment.
Chemotherapy is given according to the current standard of the participating institution. In practice, patients will usually receive either carboplatin + gemcitabine or carboplatin + vinorelbine. Treatment duration with chemotherapy is 4 cycles (cycle length 3 weeks) in the absence of tumour progression or prohibitive toxicity.
Treatment with the study drug starts on the first day of cancer chemotherapy. Maximum treatment duration is one year. Treatment will be stopped earlier in case of objective tumor progression, serious toxicity that is considered to be related to the study drug or if the patient wants to stop treatment.
The size of the study is based on the hypothesis that celecoxib could prolong median survival by 8 weeks as compared to 7.5 months in the placebo group. With standard statistical requirements (type I error 5%, type II error 20%), the calculated number of patients was 760.
The study was supported by the Swedish Lung Cancer Study Group and organized as a multicenter trial, with participation of seven university hospitals and six smaller hospitals. The number of new cases of NSCLC stage IIIB-IV and performance status 0-2 in Sweden is around 1200/year. It was expected that 20% of the patients could be included in the study, which would make completion possible in three years.
The study was opened for randomization on May 31, 2006. Recruitment of patients was lower than expected. The study was closed for further randomization on May 31, 2009, as originally planned. 319 patients were included. Since maximum duration of treatment with the study drug is one year, the code will be broken after May 31, 2010. Data analysis is planned to take place in summer and autumn, 2010.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Celecoxib, Placebo
- Keywords
- Cyclooxygenase-2 inhibitors, Celecoxib, Carcinoma, non-small-cell lung, Antineoplastic agents, Therapy, palliative, Survival
- 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.
CelecoxibDrug
Also called Celebra, Onsenal
Celecoxib 400 mg twice daily, orally, starting on the same day as palliative chemotherapy. Maximum duration of treatment is one year. Treatment should be terminated earlier in case of disease progression, unacceptable toxicity, or if the patient wants to stop treatment.
PlaceboDrug
One capsule twice daily, starting on the same day as palliative chemotherapy. Maximum duration of treatment is one year. Treatment should be terminated earlier in case of disease progression, unacceptable toxicity, or if the patient wants to stop treatment.
| Study group | Role | What they receive |
|---|---|---|
| Celecoxib | Active comparator | Four cycles of combination chemotherapy, usually with carboplatin + gemcitabine or carboplatin + vinorelbine, plus celecoxib 400 mg b.i.d. Treatment with celecoxib is continued after completion of chemotherapy. Maximum treatment duration is one year. Receives: Drug: Celecoxib |
| Placebo | Placebo comparator | Chemotherapy as in arm 1 plus placebo capsules, b.i.d. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: Minimum follow-up 1 yr after randomization
Secondary outcomes (5)
Quality of life
Measured: Week 0, 3, 6, 9, 12, 20, 28, 36, 44
Progression-free survival
Measured: minimum follow-up 1 yr after randomization
Toxicity
Measured: Within one month after stopping study drug
Cardiovascular events
Measured: Within one month after stopping study drug
Biological parameters (plasma VEGF, proteomics)
Measured: Week 0, 6, 12, and 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2006 (estimated)
- Study startMay 2006
- Primary completionMay 2010 (estimated)
- Study completionSep 2010 (estimated)
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 Non-Small Cell Lung CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Lung Cancer Study Group, Pfizer
- Investigators
- Sverre Sörenson, MD, PhD, Study chair, Department of Medicine, Ryhov County Hospital, Jönköping, Sweden, Department of Pulmonary Medicine, University Hospital, Linköping, Sweden, and Department of Medical and Health Sciences, Linköping University, SwedenAndrea Koch, MD, Principal investigator, Allergy Centre, University Hospital, Linköping, Sweden, Department of Pulmonary Medicine, University Hospital, Linköping, Sweden, and Department of Medical and Health Sciences, Linköping University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00300729
- Sponsor's protocol ID
- SLCSG0501
- Acronym
- CYCLUS
- Status last verified
- Jun 2009
- First submitted
- 8 Mar 2006
- Last updated
- 30 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Koch A, Bergman B, Holmberg E, Sederholm C, Ek L, Kosieradzki J, Lamberg K, Thaning L, Ydreborg SO, Sorenson S; Swedish Lung Cancer Study Group. Effect of celecoxib on survival in patients with advanced non-small cell lung cancer: a double blind randomised clinical phase III trial (CYCLUS study) by the Swedish Lung Cancer Study Group. Eur J Cancer. 2011 Jul;47(10):1546-55. doi: 10.1016/j.ejca.2011.03.035. Epub 2011 May 10.
PubMed 21565487
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
- Cox-2-Inhibitor and Chemotherapy in Non-Small Cell Lung Cancer. A Prospective Randomized Double-Blind Study
- ClinicalTrials.gov ID
- NCT00300729
- Acronym / sponsor ID
- CYCLUS / SLCSG0501
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Cyclooxygenase-2 inhibitors, Celecoxib, Carcinoma, non-small-cell lung, Antineoplastic agents, Therapy, palliative, Survival
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 319 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Collaborators
- Swedish Lung Cancer Study Group, Pfizer
- Study start
- May 2006
- Primary completion
- May 2010 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 9 Mar 2006 (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 primary purpose of the study is to investigate if daily treatment with celecoxib, an inhibitor of cyclooxygenase-2, can prolong survival in patients with advanced non-small cell lung cancer who receive anticancer chemotherapy as their primary treatment. Secondary endpoints of the study are: health-related quality of life, toxicity, cardiovascular events, progression-free survival, and biological markers (VEGF, proteomics).
Detailed description
The study (CYCLUS trial, CY-cyclooxygenase-2 inhibitor, Chemotherapy, LUng cancer, Survival) is a prospective randomized double-blind multicenter trial. Patients are randomized to receive celecoxib at a dose of 400 mg b.i.d. or placebo. Primary endpoint of the trial is survival. Secondary endpoints are: quality of life, progression-free survival, toxicity, cardiovascular events, and biological parameters (plasma VEGF and proteomics).
The rationale behind the study consists of preclinical observations of antitumor effect of celecoxib in NSCLC. Inhibition of angiogenesis and proliferation as well as increased apoptosis has been demonstrated. In addition, pilot studies have shown that the combination of chemotherapy and celecoxib is feasible. No unexpected toxicity has been recorded in such trials. Furthermore, a randomized study of indomethacin, prednisolone or placebo in other types of advanced cancer, mainly gastrointestinal, showed a survival advantage for patients receiving antiinflammatory treatment.
Chemotherapy is given according to the current standard of the participating institution. In practice, patients will usually receive either carboplatin + gemcitabine or carboplatin + vinorelbine. Treatment duration with chemotherapy is 4 cycles (cycle length 3 weeks) in the absence of tumour progression or prohibitive toxicity.
Treatment with the study drug starts on the first day of cancer chemotherapy. Maximum treatment duration is one year. Treatment will be stopped earlier in case of objective tumor progression, serious toxicity that is considered to be related to the study drug or if the patient wants to stop treatment.
The size of the study is based on the hypothesis that celecoxib could prolong median survival by 8 weeks as compared to 7.5 months in the placebo group. With standard statistical requirements (type I error 5%, type II error 20%), the calculated number of patients was 760.
The study was supported by the Swedish Lung Cancer Study Group and organized as a multicenter trial, with participation of seven university hospitals and six smaller hospitals. The number of new cases of NSCLC stage IIIB-IV and performance status 0-2 in Sweden is around 1200/year. It was expected that 20% of the patients could be included in the study, which would make completion possible in three years.
The study was opened for randomization on May 31, 2006. Recruitment of patients was lower than expected. The study was closed for further randomization on May 31, 2009, as originally planned. 319 patients were included. Since maximum duration of treatment with the study drug is one year, the code will be broken after May 31, 2010. Data analysis is planned to take place in summer and autumn, 2010.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Celecoxib | Active comparator | Drug: CelecoxibFour cycles of combination chemotherapy, usually with carboplatin + gemcitabine or carboplatin + vinorelbine, plus celecoxib 400 mg b.i.d. Treatment with celecoxib is continued after completion of chemotherapy. Maximum treatment duration is one year. |
| Placebo | Placebo comparator | Drug: PlaceboChemotherapy as in arm 1 plus placebo capsules, b.i.d. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
- Age at least 18 years. No upper age limit.
- Disease stage IIIB or IV.
- Performance status (WHO) 0-2
- Treatment with curative intent is not possible
Key exclusion criteria (6 listed)
- Regular use of NSAID (except ASA at a dose of 50-100 mg daily)
- Active duodenal ulcer, ongoing gastrointestinal bleeding or inflammatory bowel disease
- Serious heart failure or serious liver disease
- Hypersensitivity so sulfonamides
- Pregnancy
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 |
|---|---|---|
| CelecoxibAlso: Celebra, OnsenalCelecoxib 400 mg twice daily, orally, starting on the same day as palliative chemotherapy. Maximum duration of treatment is one year. Treatment should be terminated earlier in case of disease progression, unacceptable toxicity, or if the patient wants to stop treatment. | Drug | Celecoxib |
| PlaceboOne capsule twice daily, starting on the same day as palliative chemotherapy. Maximum duration of treatment is one year. Treatment should be terminated earlier in case of disease progression, unacceptable toxicity, or if the patient wants to stop treatment. | Drug | Placebo |
Primary outcome
Overall survival
Time frame: Minimum follow-up 1 yr after randomization
5 secondary outcomes
Quality of life
Time frame: Week 0, 3, 6, 9, 12, 20, 28, 36, 44
Progression-free survival
Time frame: minimum follow-up 1 yr after randomization
Toxicity
Time frame: Within one month after stopping study drug
Cardiovascular events
Time frame: Within one month after stopping study drug
Biological parameters (plasma VEGF, proteomics)
Time frame: Week 0, 6, 12, and 20
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2009.
- Derived from this study: PubMed 21565487Koch A, Bergman B, Holmberg E, Sederholm C, Ek L, Kosieradzki J, Lamberg K, Thaning L, Ydreborg SO, Sorenson S; Swedish Lung Cancer Study Group. Effect of celecoxib on survival in patients with advanced non-small cell lung cancer: a double blind randomised clinical phase III trial (CYCLUS study) by the Swedish Lung Cancer Study Group. Eur J Cancer. 2011 Jul;47(10):1546-55. doi: 10.1016/j.ejca.2011.03.035. Epub 2011 May 10.
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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.
Sverre Sörenson, MD, PhD study chair
Department of Medicine, Ryhov County Hospital, Jönköping, Sweden, Department of Pulmonary Medicine, University Hospital, Linköping, Sweden, and Department of Medical and Health Sciences, Linköping University, Sweden
Andrea Koch, MD principal investigator
Allergy Centre, University Hospital, Linköping, Sweden, Department of Pulmonary Medicine, University Hospital, Linköping, Sweden, and Department of Medical and Health Sciences, Linköping University, Sweden
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Celecoxib in people with Non-Small Cell Lung Cancer, run by University Hospital, Linkoeping at 13 sites in Sweden.
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 11 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: status not confirmed, 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 13 sites in Sweden. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Overall survival (time frame: Minimum follow-up 1 yr after randomization). 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 NCT00300729, 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 30 Jun 2009.