Carcinoma, Non-Small-Cell LungPhase 4NCT03172988
Dexamethasone, Flurbiprofen Axetil and Long-term Survival After Lung Cancer Surgery
A Phase 4 study testing Dexamethasone, Normal saline and Flurbiprofen axetil in people with Carcinoma, Non-Small-Cell Lung and Surgery, run by Peking University First Hospital at 2 sites in China.
Trial summary
Surgical resection is the first choice treatment for patients with non-small-cell lung cancer. Despite of advances in surgical techniques, the long-term survival rate of postoperative patient is far from optimal. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Surgery, Dexamethasone
- What is being tested?
- Dexamethasone, Normal saline and Flurbiprofen axetil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 2 sitesChina
- Study dates
- 2 Aug 2017to 26 Dec 2018
- Phase
- Phase 4
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 85 years old;
- Diagnose as non-small-cell lung cancer (stage IA-IIIA);
- Plan to undergo surgical resection;
- Provide written informed consents.
Who cannot join
- Clinical evidences suggest remote metastasis of the primary cancer; have received radiotherapy, chemotherapy or targeted therapy before surgery; have received previous surgery for lung cancer; diagnosed with other cancer (other than lung cancer) currently or previously;
- History of therapy with glucocorticoids or immunosuppressants within 1 year, or therapy with non-steroidal anti-inflammatory drugs (NSAIDs) within 1 month;
- Allergy to glucocorticoids or NSAIDs;
- Contraindications to dexamethasone or flurbiprofen axetil, such as asthma or hives urticaria induced by aspirin or other NSAIDs; active digestive tract ulcer or bleeding, or history of repeated digestive tract ulcer or bleeding; coagulopathy (platelet count < 50*10^9/L, International Normalized Ratio > 1.4, or activated partial thromboplastin time > 4 seconds above upper limit); current therapy with lomefloxacin, norfloxacin, or enoxacin; severe cardiac dysfunction (New York heart association class 3 or above, or Left Ventricular Ejection Fraction less than 30%) or myocardial infarction within 3 months; liver injury (transaminase higher than 2 times of upper limit); kidney injury (creatinine higher than 1.5 times of upper limit); uncontrolled severe hypertension before surgery (> 180/120 mmHg);
- ASA physical status class IV or higher;
- Refuse to use patient-controlled analgesia pump after surgery;
- Other conditions that are considered unsuitable for study participation.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Peking University First Hospital
Beijing, Beijing Municipality, 100035
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
About this study
Official title: Impact of Perioperative Dexamethasone and Flurbiprofen Axetil on Long-term Survival After Surgery for Non-small Cell Lung Cancer: A 2x2 Factorial Randomized Controlled Trial
Surgical resection is the first choice treatment for patients with non-small-cell lung cancer. Despite of advances in surgical techniques, the long-term survival rate of postoperative patient is far from optimal. In a recent retrospective cohort study of the applicants, 588 patients after surgery for non-small-cell lung cancer were followed up for a medium of 5.2 years. The results showed that perioperative use of dexamethasone was associated with prolonged survival; perioperative use of flurbiprofen axetil was also associated with a slightly longer survival but not statistically significant. Further analysis showed that combined administration of dexamethasone and flurbiprofen axetil had additive effect in prolonging survival. We hypothesize that, for patients undergoing surgery for non-small-cell lung cancer, perioperative administration of dexamethasone and flurbiprofen axetil may improve long-term survival. However, evidences from randomized controlled trials are still lacking in this aspect.
Read the detailed description
Surgical resection is the first choice treatment for patients with non-small-cell lung cancer. Although improvements of surgical techniques have reduced the incidence of complications, the long-term survival rate of postoperative patient is far from optimal. Cancer metastasis and recurrence are the main reasons that lead to long-term postoperative death. It is unavoidable that some cancer cells will be disseminated into the blood circulation or the lymphatic systems during surgery. The development of metastasis and recurrence are dependent on the balance between the immune function of the body and the cancer-promoting factors during the perioperative period.
Studies showed that surgical stress inhibits the cytotoxic effects of natural killer cells and the activity of T cells, and thus leads to immunosuppression of the body. Furthermore, perioperative management such as anesthetic techniques, anesthetics and related drugs, blood transfusion and hypothermia can also affect immune function. For example, studies showed that inhalational anesthetics and opioids aggravate immunosuppression, and may lead to worse outcome; whereas regional anesthesia and non-steroid anti-inflammatory drugs relieve immunosuppression, and thus may improve outcome. Glucocorticoids (mainly dexamethasone) are frequently used for prevention of postoperative nausea and vomiting. A recent retrospective study showed that, for patients undergoing surgery for pancreatic cancer, perioperative use of dexamethasone was associated with improved long-term survival. However, prospective randomized controlled trials are still lacking to demonstrate the relationship between perioperative management and long-term outcome in cancer patients.
A recent retrospective cohort study of the applicants recruited 588 patients after surgery for non-small-cell lung cancer and performed a postoperative follow-up for a medium of 5.2 years. After adjusting the confounding factors with multivariate logistic regression model, perioperative use of dexamethasone (medium dose 10 mg, for prevention of postoperative nausea and vomiting) was associated with prolonged survival (HR 0.70, 95% CI 0.54-0.89; P = 0.004); perioperative use of flurbiprofen axetil (medium dose 200 mg, for postoperative analgesia) was also associated with a slightly longer survival but not statistically significant (HR 0.81, 95% CI 0.63-1.03; P = 0.083). Further analysis showed that combined administration of dexamethasone and flurbiprofen axetil had additive effect in prolonging survival (compared to no use of both: adjusted HR 0.57, 95% CI 0.38-0.84, P = 0.005).
The investigators hypothesize that, for patients undergoing surgery for non-small-cell lung cancer, perioperative administration of dexamethasone and flurbiprofen axetil may improve long-term survival. However, evidences from randomized controlled trials are still lacking in this aspect.
- Conditions
- Carcinoma, Non-Small-Cell Lung, Surgery, Dexamethasone, Flubiprofen Axetil, Long-term Effects Secondary to Cancer Therapy in Adults
- Being tested
- Dexamethasone, Normal saline, Flurbiprofen axetil, Lipid microsphere
- Keywords
- Carcinoma, Non-Small-Cell Lung, Surgery, Dexamethasone, Flurbiprofen axetil, Long-term 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.
DexamethasoneDrug
Also called Dexamethasone sodium phosphate injection
Dexamethasone 10 mg is administered before anesthesia induction.
Normal salineDrug
Normal saline 2 ml is administered before anesthesia induction.
Flurbiprofen axetilDrug
Also called Flurbiprofen axetil injection
Flurbiprofen axetil 50 mg is administered before the start of surgery. Postoperative analgesia is provided with a patient-controlled analgesia pump, which is established with 100 ml of 1.25 μg/ml sufentanil and 2 mg/ml flurbiprofen axetil, programmed to deliver a 2 ml bolus with a lockout interval of 6-8 min and a background infusion of 1 ml/h.
Lipid microsphereDrug
Also called Lipid microsphere injection
Lipid microsphere 5 ml is administered before the start of surgery. Postoperative analgesia is provided with a patient-controlled analgesia pump, which is established with 100 ml of 1.25 μg/ml sufentanil and 20 ml lipid microsphere, programmed to deliver a 2 ml bolus with a lockout interval of 6-8 min and a background infusion of 1 ml/h.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone and flurbiprofen axetil | Experimental | Dexamethasone 10 mg is administered before anesthesia induction. Flurbiprofen axetil 50 mg is administered before the start of surgery. Postoperative analgesia is provided with a patient-controlled analgesia pump, which is established with 100 ml of 1.25 μg/ml sufentanil and 2 mg/ml flurbiprofen axetil, programmed to deliver a 2 ml bolus with a lockout interval of 6-8 min and a background infusion of 1 ml/h. Receives: Drug: Dexamethasone; Drug: Flurbiprofen axetil |
| Dexamethasone and lipid microsphere | Experimental | Dexamethasone 10 mg is administered before anesthesia induction. Lipid microsphere 5 ml is administered before the start of surgery. Postoperative analgesia is provided with a patient-controlled analgesia pump, which is established with 100 ml of 1.25 μg/ml sufentanil and 20 ml lipid microsphere, programmed to deliver a 2 ml bolus with a lockout interval of 6-8 min and a background infusion of 1 ml/h. Receives: Drug: Dexamethasone; Drug: Lipid microsphere |
| Normal saline and flurbiprofen axetil | Experimental | Normal saline 2 ml is administered before anesthesia induction. Flurbiprofen axetil 50 mg is administered before the start of surgery. Postoperative analgesia is provided with a patient-controlled analgesia pump, which is established with 100 ml of 1.25 μg/ml sufentanil and 2 mg/ml flurbiprofen axetil, programmed to deliver a 2 ml bolus with a lockout interval of 6-8 min and a background infusion of 1 ml/h. Receives: Drug: Normal saline; Drug: Flurbiprofen axetil |
| Normal saline and lipid microsphere | Placebo comparator | Normal saline 2 ml is administered before anesthesia induction. Lipid microsphere 5 ml is administered before the start of surgery. Postoperative analgesia is provided with a patient-controlled analgesia pump, which is established with 100 ml of 1.25 μg sufentanil and 20 ml lipid microsphere, programmed to deliver a 2 ml bolus with a lockout interval of 6-8 min and a background infusion of 1 ml/h. Receives: Drug: Normal saline; Drug: Lipid microsphere |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year survival after surgery
Duration of survival within 3 years after surgery.
Measured: From end of surgery until 3 years after surgery.
Secondary outcomes (5)
Survival rates at different times after surgery
Survival rates at 6 months and 1, 2, 3 years after surgery.
Measured: At 6 months and 1, 2, 3 years after surgery.
Duration of recurrence-free survival
Duration of recurrence-free survival within 3 years after surgery
Measured: From end of surgery until 3 years after surgery.
Recurrence-free survival rates at different times after surgery
Recurrence-free survival rates at 6 months and 1, 2, 3 years after surgery.
Measured: At 6 months and 1, 2, 3 years after surgery.
Quality of life (WHOQOL-BREF) at 3 years after surgery
Assessed with World Health Organization Quality of Life Brief Scale (WHOQOL-BREF).
Measured: At 3 years after surgery.
Cognitive function (TICS-m) at 3 years after surgery
Assessed with Telephone Interview for Cognitive Status-modified (TICS-m).
Measured: At 3 years after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start2 Aug 2017
- Primary completion26 Dec 2018
- Study completion26 Dec 2018
Why it stopped: Protocol violation occurred frequently during the postoperative period.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute
- Responsible party
- Principal investigator, Dong-Xin Wang, Peking University First Hospital
- Investigators
- Dong-Xin Wang, MD, PhD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03172988
- Sponsor's protocol ID
- 2017[1359]-2
- Status last verified
- Mar 2019
- First submitted
- 30 May 2017
- Last updated
- 5 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Neeman E, Ben-Eliyahu S. Surgery and stress promote cancer metastasis: new outlooks on perioperative mediating mechanisms and immune involvement. Brain Behav Immun. 2013 Mar;30 Suppl(Suppl):S32-40. doi: 10.1016/j.bbi.2012.03.006. Epub 2012 Apr 4.
PubMed 22504092Ben-David B. Anaesthesia in Cancer Surgery: Can it Affect Cancer Survival? Curr Clin Pharmacol. 2016;11(1):4-20. doi: 10.2174/1574884711666160122093154.
PubMed 26638975Cassinello F, Prieto I, del Olmo M, Rivas S, Strichartz GR. Cancer surgery: how may anesthesia influence outcome? J Clin Anesth. 2015 May;27(3):262-72. doi: 10.1016/j.jclinane.2015.02.007. Epub 2015 Mar 11.
PubMed 25769963Bugada D, Bellini V, Fanelli A, Marchesini M, Compagnone C, Baciarello M, Allegri M, Fanelli G. Future Perspectives of ERAS: A Narrative Review on the New Applications of an Established Approach. Surg Res Pract. 2016;2016:3561249. doi: 10.1155/2016/3561249. Epub 2016 Jul 18.
PubMed 27504486Call TR, Pace NL, Thorup DB, Maxfield D, Chortkoff B, Christensen J, Mulvihill SJ. Factors associated with improved survival after resection of pancreatic adenocarcinoma: a multivariable model. Anesthesiology. 2015 Feb;122(2):317-24. doi: 10.1097/ALN.0000000000000489.
PubMed 25305092Skevington SM, McCrate FM. Expecting a good quality of life in health: assessing people with diverse diseases and conditions using the WHOQOL-BREF. Health Expect. 2012 Mar;15(1):49-62. doi: 10.1111/j.1369-7625.2010.00650.x. Epub 2011 Jan 31.
PubMed 21281412
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Perioperative Dexamethasone and Flurbiprofen Axetil on Long-term Survival After Surgery for Non-small Cell Lung Cancer: A 2x2 Factorial Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03172988
- Acronym / sponsor ID
- 2017[1359]-2
- Conditions
- Carcinoma, Non-Small-Cell Lung, Surgery, Dexamethasone, Flubiprofen Axetil, Long-term Effects Secondary to Cancer Therapy in Adults
- Keywords
- Carcinoma, Non-Small-Cell Lung, Surgery, Dexamethasone, Flurbiprofen axetil, Long-term survival
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Protocol violation occurred frequently during the postoperative period.
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute
- Study start
- 2 Aug 2017 (actual)
- Primary completion
- 26 Dec 2018 (actual)
- Study completion
- 26 Dec 2018 (actual)
- First posted
- 1 Jun 2017 (actual)
- 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.
Surgical resection is the first choice treatment for patients with non-small-cell lung cancer. Despite of advances in surgical techniques, the long-term survival rate of postoperative patient is far from optimal. In a recent retrospective cohort study of the applicants, 588 patients after surgery for non-small-cell lung cancer were followed up for a medium of 5.2 years. The results showed that perioperative use of dexamethasone was associated with prolonged survival; perioperative use of flurbiprofen axetil was also associated with a slightly longer survival but not statistically significant. Further analysis showed that combined administration of dexamethasone and flurbiprofen axetil had additive effect in prolonging survival. We hypothesize that, for patients undergoing surgery for non-small-cell lung cancer, perioperative administration of dexamethasone and flurbiprofen axetil may improve long-term survival. However, evidences from randomized controlled trials are still lacking in this aspect.
Detailed description
Surgical resection is the first choice treatment for patients with non-small-cell lung cancer. Although improvements of surgical techniques have reduced the incidence of complications, the long-term survival rate of postoperative patient is far from optimal. Cancer metastasis and recurrence are the main reasons that lead to long-term postoperative death. It is unavoidable that some cancer cells will be disseminated into the blood circulation or the lymphatic systems during surgery. The development of metastasis and recurrence are dependent on the balance between the immune function of the body and the cancer-promoting factors during the perioperative period.
Studies showed that surgical stress inhibits the cytotoxic effects of natural killer cells and the activity of T cells, and thus leads to immunosuppression of the body. Furthermore, perioperative management such as anesthetic techniques, anesthetics and related drugs, blood transfusion and hypothermia can also affect immune function. For example, studies showed that inhalational anesthetics and opioids aggravate immunosuppression, and may lead to worse outcome; whereas regional anesthesia and non-steroid anti-inflammatory drugs relieve immunosuppression, and thus may improve outcome. Glucocorticoids (mainly dexamethasone) are frequently used for prevention of postoperative nausea and vomiting. A recent retrospective study showed that, for patients undergoing surgery for pancreatic cancer, perioperative use of dexamethasone was associated with improved long-term survival. However, prospective randomized controlled trials are still lacking to demonstrate the relationship between perioperative management and long-term outcome in cancer patients.
A recent retrospective cohort study of the applicants recruited 588 patients after surgery for non-small-cell lung cancer and performed a postoperative follow-up for a medium of 5.2 years. After adjusting the confounding factors with multivariate logistic regression model, perioperative use of dexamethasone (medium dose 10 mg, for prevention of postoperative nausea and vomiting) was associated with prolonged survival (HR 0.70, 95% CI 0.54-0.89; P = 0.004); perioperative use of flurbiprofen axetil (medium dose 200 mg, for postoperative analgesia) was also associated with a slightly longer survival but not statistically significant (HR 0.81, 95% CI 0.63-1.03; P = 0.083). Further analysis showed that combined administration of dexamethasone and flurbiprofen axetil had additive effect in prolonging survival (compared to no use of both: adjusted HR 0.57, 95% CI 0.38-0.84, P = 0.005).
The investigators hypothesize that, for patients undergoing surgery for non-small-cell lung cancer, perioperative administration of dexamethasone and flurbiprofen axetil may improve long-term survival. However, evidences from randomized controlled trials are still lacking in this aspect.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone and flurbiprofen axetil | Experimental | Drug: Dexamethasone, Drug: Flurbiprofen axetilDexamethasone 10 mg is administered before anesthesia induction. Flurbiprofen axetil 50 mg is administered before the start of surgery. Postoperative analgesia is provided with a patient-controlled analgesia pump, which is established with 100 ml of 1.25 μg/ml sufentanil and 2 mg/ml flurbiprofen axetil, programmed to deliver a 2 ml bolus with a lockout interval of 6-8 min and a background infusion of 1 ml/h. |
| Dexamethasone and lipid microsphere | Experimental | Drug: Dexamethasone, Drug: Lipid microsphereDexamethasone 10 mg is administered before anesthesia induction. Lipid microsphere 5 ml is administered before the start of surgery. Postoperative analgesia is provided with a patient-controlled analgesia pump, which is established with 100 ml of 1.25 μg/ml sufentanil and 20 ml lipid microsphere, programmed to deliver a 2 ml bolus with a lockout interval of 6-8 min and a background infusion of 1 ml/h. |
| Normal saline and flurbiprofen axetil | Experimental | Drug: Normal saline, Drug: Flurbiprofen axetilNormal saline 2 ml is administered before anesthesia induction. Flurbiprofen axetil 50 mg is administered before the start of surgery. Postoperative analgesia is provided with a patient-controlled analgesia pump, which is established with 100 ml of 1.25 μg/ml sufentanil and 2 mg/ml flurbiprofen axetil, programmed to deliver a 2 ml bolus with a lockout interval of 6-8 min and a background infusion of 1 ml/h. |
| Normal saline and lipid microsphere | Placebo comparator | Drug: Normal saline, Drug: Lipid microsphereNormal saline 2 ml is administered before anesthesia induction. Lipid microsphere 5 ml is administered before the start of surgery. Postoperative analgesia is provided with a patient-controlled analgesia pump, which is established with 100 ml of 1.25 μg sufentanil and 20 ml lipid microsphere, programmed to deliver a 2 ml bolus with a lockout interval of 6-8 min and a background infusion of 1 ml/h. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age from 18 to 85 years old;
- Diagnose as non-small-cell lung cancer (stage IA-IIIA);
- Plan to undergo surgical resection;
- Provide written informed consents.
Key exclusion criteria (7 listed)
- Clinical evidences suggest remote metastasis of the primary cancer; have received radiotherapy, chemotherapy or targeted therapy before surgery; have received previous surgery for lung cancer; diagnosed with other cancer (other than lung cancer) currently or previously;
- History of therapy with glucocorticoids or immunosuppressants within 1 year, or therapy with non-steroidal anti-inflammatory drugs (NSAIDs) within 1 month;
- Allergy to glucocorticoids or NSAIDs;
- Contraindications to dexamethasone or flurbiprofen axetil, such as asthma or hives urticaria induced by aspirin or other NSAIDs; active digestive tract ulcer or bleeding, or history of repeated digestive tract ulcer or bleeding; coagulopathy (platelet count < 50*10^9/L, International Normalized Ratio > 1.4, or activated partial thromboplastin time > 4 seconds above upper limit); current therapy with lomefloxacin, norfloxacin, or enoxacin; severe cardiac dysfunction (New York heart association class 3 or above, or Left Ventricular Ejection Fraction less than 30%) or myocardial infarction within 3 months; liver injury (transaminase higher than 2 times of upper limit); kidney injury (creatinine higher than 1.5 times of upper limit); uncontrolled severe hypertension before surgery (> 180/120 mmHg);
- ASA physical status class IV or higher;
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 |
|---|---|---|
| DexamethasoneAlso: Dexamethasone sodium phosphate injectionDexamethasone 10 mg is administered before anesthesia induction. | Drug | Dexamethasone and flurbiprofen axetil, Dexamethasone and lipid microsphere |
| Normal salineNormal saline 2 ml is administered before anesthesia induction. | Drug | Normal saline and flurbiprofen axetil, Normal saline and lipid microsphere |
| Flurbiprofen axetilAlso: Flurbiprofen axetil injectionFlurbiprofen axetil 50 mg is administered before the start of surgery. Postoperative analgesia is provided with a patient-controlled analgesia pump, which is established with 100 ml of 1.25 μg/ml sufentanil and 2 mg/ml flurbiprofen axetil, programmed to deliver a 2 ml bolus with a lockout interval of 6-8 min and a background infusion of 1 ml/h. | Drug | Dexamethasone and flurbiprofen axetil, Normal saline and flurbiprofen axetil |
| Lipid microsphereAlso: Lipid microsphere injectionLipid microsphere 5 ml is administered before the start of surgery. Postoperative analgesia is provided with a patient-controlled analgesia pump, which is established with 100 ml of 1.25 μg/ml sufentanil and 20 ml lipid microsphere, programmed to deliver a 2 ml bolus with a lockout interval of 6-8 min and a background infusion of 1 ml/h. | Drug | Dexamethasone and lipid microsphere, Normal saline and lipid microsphere |
Primary outcome
3-year survival after surgery
Time frame: From end of surgery until 3 years after surgery.
Duration of survival within 3 years after surgery.
5 secondary outcomes
Survival rates at different times after surgery
Time frame: At 6 months and 1, 2, 3 years after surgery.
Duration of recurrence-free survival
Time frame: From end of surgery until 3 years after surgery.
Recurrence-free survival rates at different times after surgery
Time frame: At 6 months and 1, 2, 3 years after surgery.
Quality of life (WHOQOL-BREF) at 3 years after surgery
Time frame: At 3 years after surgery.
Cognitive function (TICS-m) at 3 years after surgery
Time frame: At 3 years after surgery.
Results and safety
The study was stopped early (reason given: Protocol violation occurred frequently during the postoperative period.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Background: PubMed 22504092Neeman E, Ben-Eliyahu S. Surgery and stress promote cancer metastasis: new outlooks on perioperative mediating mechanisms and immune involvement. Brain Behav Immun. 2013 Mar;30 Suppl(Suppl):S32-40. doi: 10.1016/j.bbi.2012.03.006. Epub 2012 Apr 4.
- Background: PubMed 26638975Ben-David B. Anaesthesia in Cancer Surgery: Can it Affect Cancer Survival? Curr Clin Pharmacol. 2016;11(1):4-20. doi: 10.2174/1574884711666160122093154.
- Background: PubMed 25769963Cassinello F, Prieto I, del Olmo M, Rivas S, Strichartz GR. Cancer surgery: how may anesthesia influence outcome? J Clin Anesth. 2015 May;27(3):262-72. doi: 10.1016/j.jclinane.2015.02.007. Epub 2015 Mar 11.
- Background: PubMed 27504486Bugada D, Bellini V, Fanelli A, Marchesini M, Compagnone C, Baciarello M, Allegri M, Fanelli G. Future Perspectives of ERAS: A Narrative Review on the New Applications of an Established Approach. Surg Res Pract. 2016;2016:3561249. doi: 10.1155/2016/3561249. Epub 2016 Jul 18.
- Background: PubMed 25305092Call TR, Pace NL, Thorup DB, Maxfield D, Chortkoff B, Christensen J, Mulvihill SJ. Factors associated with improved survival after resection of pancreatic adenocarcinoma: a multivariable model. Anesthesiology. 2015 Feb;122(2):317-24. doi: 10.1097/ALN.0000000000000489.
- Background: PubMed 21281412Skevington SM, McCrate FM. Expecting a good quality of life in health: assessing people with diverse diseases and conditions using the WHOQOL-BREF. Health Expect. 2012 Mar;15(1):49-62. doi: 10.1111/j.1369-7625.2010.00650.x. Epub 2011 Jan 31.
- Individual participant dataSharing planned: No
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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.
Dong-Xin Wang, MD, PhD principal investigator
Peking University First Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone, Normal saline and Flurbiprofen axetil in people with Carcinoma, Non-Small-Cell Lung and Surgery, run by Peking University First Hospital at 2 sites in China.
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 4 inclusion and 7 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 5 Mar 2019. 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 China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: Protocol violation occurred frequently during the postoperative period.). 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?
3-year survival after surgery (time frame: From end of surgery until 3 years after surgery.). 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 NCT03172988, which also lists 6 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 Mar 2019; AzTrials last refreshed its copy on 8 Nov 2026.