Lung CancerNCT02801409

Epidural Anesthesia-analgesia and Long-term Survival After Lung Cancer Surgery

A study testing General anesthesia alone and Combined epidural-general anesthesia in people with Lung Cancer and Thoracic Surgery, run by Peking University First Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Lung Cancer, Thoracic Surgery, Anesthesia, Epidural
What is being tested?: General anesthesia alone and Combined epidural-general anesthesia
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 400 participants
Where: 1 siteChina
Study dates: 25 May 2015to 30 Nov 2019
Phase: Interventional
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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult patients (aged 18-80 years);
Clinically diagnosed as primary non-small cell lung cancer of stage IA to IIIA, and scheduled for radical surgery;
Agreed to receive patient-controlled analgesia after surgery.

Who cannot join

Distant metastasis, malignant tumor in other organs, or chemo-/radiotherapy or other anti-cancer therapy before surgery;
Comorbid with autoimmune diseases, or glucocorticoid/immunosuppressant therapy within 1 year;
History of schizophrenia, epilepsy or Parkinson disease, or unable to complete preoperative assessment due to severe dementia, language barrier, or end-stage disease;
Severe hepatic disease (Child-Pugh classification C), renal failure (serum creatinine >442 umol/L or receiving renal replacement therapy), or American Society of Anesthesiologists classification IV or higher;
History of anesthesia and/or surgery within 1 year;
Contraindications to epidural anesthesia, including spinal deformity, coagulation dysfunction, local infection, and history of spinal trauma/surgery;
Allergic to any medications used during the study.

Trial locations and contacts

1 site in 1 country.

China1 site

Peking University First Hospital
Beijing, Beijing Municipality, 100034

Other trials in China

About this study

Official title: Effects of Epidural Anesthesia-analgesia on Long-term Survival in Patients After Lung Cancer Surgery: A Randomized Controlled Trial

Available studies suggest that regional anesthesia-analgesia may decrease the occurrence of recurrence/metastasis in patients after cancer surgery. However, evidences from prospective studies are still lacking. The purpose of this randomized controlled trial is to investigate the effect of epidural anesthesia-analgesia on recurrence-free survival in patients undergoing lung cancer surgery.

Read the detailed description

Lung cancer is increasing and is the leading cause of cancer death. Surgical resection is the mainstay of treatment for early stage non-small cell lung cancer. However, long-term survival after lung cancer surgery is far from optimal, and cancer recurrence or metastasis is the main reason leading to cancer death in these patients.

The development of cancer recurrence/metastasis largely depends on the balance between tumor-promoting factors and immune function of the body. Studies showed that surgical manipulation releases cancer cells into circulation; and stress response induced by surgery inhibits the cell-mediated immunity. In addition, volatile anesthetics and opioids may also aggravate immunosuppression and potentially worsen long-term outcome. On the other hand, regional anesthesia can blunt surgical stress and reduce anesthetic consumption. These effects may help to preserve immune function and reduce recurrence/metastasis. However, existing evidences are insufficient to draw conclusion in this topic.

The purpose of this randomized controlled trial is to test the hypothesize that regional anesthesia-analgesia may reduce recurrence/metastasis and improve long-term survival in patients after lung cancer surgery.

Conditions: Lung Cancer, Thoracic Surgery, Anesthesia, Epidural, Neoplasm Recurrence, Local, Neoplasm Metastasis
Being tested: General anesthesia alone, Combined epidural-general anesthesia
Keywords: Lung Cancer, Surgical Resection, Epidural Anesthesia and Analgesia, Cancer recurrence/metastasis, Long-Term Outcome
Medical subject headings: Lung Neoplasms, Neoplasm Recurrence, Local, Neoplasm Metastasis, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

General anesthesia aloneDrug
General anesthesia is performed during surgery; patient-controlled intravenous analgesia is provided after surgery.
Combined epidural-general anesthesiaDrug
Combined epidural-general anesthesia is performed during surgery; patient-controlled epidural analgesia is provided after surgery.

Study groups in NCT02801409
Study group	Role	What they receive
General anesthesia alone	Active comparator	General anesthesia is performed during surgery; patient-controlled intravenous analgesia is provided after surgery. Receives: Drug: General anesthesia alone
Combined epidural-general anesthesia	Experimental	Combined epidural-general anesthesia is performed during surgery; patient-controlled epidural analgesia is provided after surgery. Receives: Drug: Combined epidural-general anesthesia

What is being measured

The primary outcome is the main question the study is designed to answer.

Recurrence-free survival after surgery.
Time from surgery to the earliest date of recurrence/metastasis or death from any cause, whichever came first.
Measured: Up to 4 years after surgery.

Secondary outcomes (8)

Rate of intensive care unit admission after surgery.
Rate of intensive care unit admission after surgery.
Measured: Up to 30 days after surgery.
Incidence of postoperative complications during hospital stay.
Postoperative complications are defined as new-onset conditions that are harmful to patients' recovery and required therapeutic intervention, i.e., class II or higher on the Clavien-Dindo classification.
Measured: Up to 30 days after surgery.
Duration of chest tube placement.
Duration of chest tube placement.
Measured: Up to 30 days after surgery.
Length of stay in hospital after surgery.
Length of stay in hospital after surgery.
Measured: Up to 30 days after surgery.
Rate of all-cause mortality during hospital stay after surgery.
Rate of all-cause mortality during hospital stay after surgery.
Measured: Up to 30 days after surgery.
Overall survival rate after surgery.
Time from surgery to all-cause death.
Measured: Up to 4 year after surgery.
Cancer-specific survival after surgery.
Time from surgery to cancer-specific death; deaths from other causes are censored at the time of death.
Measured: Up to 4 years after surgery.
Activity engagement in 1-year survivors.
Activity engagement is assessed by estimating metabolic equivalents (METs; 1 MET = 3·5 ml/min/kg resting oxygen consumption) for activity in daily life.
Measured: At the end of the first year after surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 May 201530 Nov 2019

First posted15 Jun 2016 (estimated)
Study start25 May 2015
Primary completion11 Nov 2017
Study completion30 Nov 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (42)Papers the sponsor has linked to this study.
Other trials for Lung CancerStudies 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 N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 400 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02801409
Sponsor's protocol ID: 2013[653]
Other IDs: ChiCTR-TRC-14004136
Status last verified: Aug 2020
First submitted: 12 Jun 2016
Last updated: 27 Aug 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Kelsey CR, Marks LB, Hollis D, Hubbs JL, Ready NE, D'Amico TA, Boyd JA. Local recurrence after surgery for early stage lung cancer: an 11-year experience with 975 patients. Cancer. 2009 Nov 15;115(22):5218-27. doi: 10.1002/cncr.24625.
PubMed 19672942
Sawyer TE, Bonner JA, Gould PM, Foote RL, Deschamps C, Lange CM, Li H. Factors predicting patterns of recurrence after resection of N1 non-small cell lung carcinoma. Ann Thorac Surg. 1999 Oct;68(4):1171-6. doi: 10.1016/s0003-4975(99)00678-5.
PubMed 10543475
Snyder GL, Greenberg S. Effect of anaesthetic technique and other perioperative factors on cancer recurrence. Br J Anaesth. 2010 Aug;105(2):106-15. doi: 10.1093/bja/aeq164.
PubMed 20627881
Koebel CM, Vermi W, Swann JB, Zerafa N, Rodig SJ, Old LJ, Smyth MJ, Schreiber RD. Adaptive immunity maintains occult cancer in an equilibrium state. Nature. 2007 Dec 6;450(7171):903-7. doi: 10.1038/nature06309. Epub 2007 Nov 18.
PubMed 18026089
Shakhar G, Ben-Eliyahu S. Potential prophylactic measures against postoperative immunosuppression: could they reduce recurrence rates in oncological patients? Ann Surg Oncol. 2003 Oct;10(8):972-92. doi: 10.1245/aso.2003.02.007.
PubMed 14527919
Yamaguchi K, Takagi Y, Aoki S, Futamura M, Saji S. Significant detection of circulating cancer cells in the blood by reverse transcriptase-polymerase chain reaction during colorectal cancer resection. Ann Surg. 2000 Jul;232(1):58-65. doi: 10.1097/00000658-200007000-00009.
PubMed 10862196
Hofer SO, Molema G, Hermens RA, Wanebo HJ, Reichner JS, Hoekstra HJ. The effect of surgical wounding on tumour development. Eur J Surg Oncol. 1999 Jun;25(3):231-43. doi: 10.1053/ejso.1998.0634.
PubMed 10336800
Lennard TW, Shenton BK, Borzotta A, Donnelly PK, White M, Gerrie LM, Proud G, Taylor RM. The influence of surgical operations on components of the human immune system. Br J Surg. 1985 Oct;72(10):771-6. doi: 10.1002/bjs.1800721002.
PubMed 2412626
Carter JJ, Whelan RL. The immunologic consequences of laparoscopy in oncology. Surg Oncol Clin N Am. 2001 Jul;10(3):655-77.
PubMed 11685934
Tashiro T, Yamamori H, Takagi K, Hayashi N, Furukawa K, Nitta H, Toyoda Y, Sano W, Itabashi T, Nishiya K, Hirano J, Nakajima N. Changes in immune function following surgery for esophageal carcinoma. Nutrition. 1999 Oct;15(10):760-6. doi: 10.1016/s0899-9007(99)00151-3.
PubMed 10501289
Downing JE, Miyan JA. Neural immunoregulation: emerging roles for nerves in immune homeostasis and disease. Immunol Today. 2000 Jun;21(6):281-9. doi: 10.1016/s0167-5699(00)01635-2.
PubMed 10825740
Elenkov IJ, Wilder RL, Chrousos GP, Vizi ES. The sympathetic nerve--an integrative interface between two supersystems: the brain and the immune system. Pharmacol Rev. 2000 Dec;52(4):595-638.
PubMed 11121511
Page GG, Blakely WP, Ben-Eliyahu S. Evidence that postoperative pain is a mediator of the tumor-promoting effects of surgery in rats. Pain. 2001 Feb 1;90(1-2):191-9. doi: 10.1016/s0304-3959(00)00403-6.
PubMed 11166986
Afsharimani B, Cabot PJ, Parat MO. Morphine use in cancer surgery. Front Pharmacol. 2011 Aug 8;2:46. doi: 10.3389/fphar.2011.00046. eCollection 2011.
PubMed 21852973
Xu YX, Ayala A, Chaudry IH. Prolonged immunodepression after trauma and hemorrhagic shock. J Trauma. 1998 Feb;44(2):335-41. doi: 10.1097/00005373-199802000-00018.
PubMed 9498507

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer

All Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Epidural Anesthesia-analgesia on Long-term Survival in Patients After Lung Cancer Surgery: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT02801409
Acronym / sponsor ID: 2013[653]
Conditions: Lung Cancer, Thoracic Surgery, Anesthesia, Epidural, Neoplasm Recurrence, Local, Neoplasm Metastasis
Keywords: Lung Cancer, Surgical Resection, Epidural Anesthesia and Analgesia, Cancer recurrence/metastasis, Long-Term Outcome
Study type: Interventional
Recruitment status: Completed
Enrolment: 400 participants (actual)
Lead sponsor: Peking University First HospitalUniversity, hospital or other
Study start: 25 May 2015 (actual)
Primary completion: 11 Nov 2017 (actual)
Study completion: 30 Nov 2019 (actual)
First posted: 15 Jun 2016 (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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
General anesthesia alone	Active comparator	Drug: General anesthesia aloneGeneral anesthesia is performed during surgery; patient-controlled intravenous analgesia is provided after surgery.
Combined epidural-general anesthesia	Experimental	Drug: Combined epidural-general anesthesiaCombined epidural-general anesthesia is performed during surgery; patient-controlled epidural analgesia is provided after surgery.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Adult patients (aged 18-80 years);
Clinically diagnosed as primary non-small cell lung cancer of stage IA to IIIA, and scheduled for radical surgery;
Agreed to receive patient-controlled analgesia after surgery.

Key exclusion criteria (7 listed)

Distant metastasis, malignant tumor in other organs, or chemo-/radiotherapy or other anti-cancer therapy before surgery;
Comorbid with autoimmune diseases, or glucocorticoid/immunosuppressant therapy within 1 year;
History of schizophrenia, epilepsy or Parkinson disease, or unable to complete preoperative assessment due to severe dementia, language barrier, or end-stage disease;
Severe hepatic disease (Child-Pugh classification C), renal failure (serum creatinine >442 umol/L or receiving renal replacement therapy), or American Society of Anesthesiologists classification IV or higher;
History of anesthesia and/or surgery within 1 year;

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
General anesthesia aloneGeneral anesthesia is performed during surgery; patient-controlled intravenous analgesia is provided after surgery.	Drug	General anesthesia alone
Combined epidural-general anesthesiaCombined epidural-general anesthesia is performed during surgery; patient-controlled epidural analgesia is provided after surgery.	Drug	Combined epidural-general anesthesia

Primary outcome

Recurrence-free survival after surgery.
Time frame: Up to 4 years after surgery.
Time from surgery to the earliest date of recurrence/metastasis or death from any cause, whichever came first.

8 secondary outcomes

Rate of intensive care unit admission after surgery.
Time frame: Up to 30 days after surgery.
Incidence of postoperative complications during hospital stay.
Time frame: Up to 30 days after surgery.
Duration of chest tube placement.
Time frame: Up to 30 days after surgery.
Length of stay in hospital after surgery.
Time frame: Up to 30 days after surgery.
Rate of all-cause mortality during hospital stay after surgery.
Time frame: Up to 30 days after surgery.
Overall survival rate after surgery.
Time frame: Up to 4 year after surgery.
Cancer-specific survival after surgery.
Time frame: Up to 4 years after surgery.
Activity engagement in 1-year survivors.
Time frame: At the end of the first year after surgery.

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 Aug 2020.
Background: PubMed 19672942Kelsey CR, Marks LB, Hollis D, Hubbs JL, Ready NE, D'Amico TA, Boyd JA. Local recurrence after surgery for early stage lung cancer: an 11-year experience with 975 patients. Cancer. 2009 Nov 15;115(22):5218-27. doi: 10.1002/cncr.24625.
Background: PubMed 10543475Sawyer TE, Bonner JA, Gould PM, Foote RL, Deschamps C, Lange CM, Li H. Factors predicting patterns of recurrence after resection of N1 non-small cell lung carcinoma. Ann Thorac Surg. 1999 Oct;68(4):1171-6. doi: 10.1016/s0003-4975(99)00678-5.
Background: PubMed 20627881Snyder GL, Greenberg S. Effect of anaesthetic technique and other perioperative factors on cancer recurrence. Br J Anaesth. 2010 Aug;105(2):106-15. doi: 10.1093/bja/aeq164.
Background: PubMed 18026089Koebel CM, Vermi W, Swann JB, Zerafa N, Rodig SJ, Old LJ, Smyth MJ, Schreiber RD. Adaptive immunity maintains occult cancer in an equilibrium state. Nature. 2007 Dec 6;450(7171):903-7. doi: 10.1038/nature06309. Epub 2007 Nov 18.
Background: PubMed 14527919Shakhar G, Ben-Eliyahu S. Potential prophylactic measures against postoperative immunosuppression: could they reduce recurrence rates in oncological patients? Ann Surg Oncol. 2003 Oct;10(8):972-92. doi: 10.1245/aso.2003.02.007.
Background: PubMed 10862196Yamaguchi K, Takagi Y, Aoki S, Futamura M, Saji S. Significant detection of circulating cancer cells in the blood by reverse transcriptase-polymerase chain reaction during colorectal cancer resection. Ann Surg. 2000 Jul;232(1):58-65. doi: 10.1097/00000658-200007000-00009.
Background: PubMed 10336800Hofer SO, Molema G, Hermens RA, Wanebo HJ, Reichner JS, Hoekstra HJ. The effect of surgical wounding on tumour development. Eur J Surg Oncol. 1999 Jun;25(3):231-43. doi: 10.1053/ejso.1998.0634.
Background: PubMed 2412626Lennard TW, Shenton BK, Borzotta A, Donnelly PK, White M, Gerrie LM, Proud G, Taylor RM. The influence of surgical operations on components of the human immune system. Br J Surg. 1985 Oct;72(10):771-6. doi: 10.1002/bjs.1800721002.
Background: PubMed 11685934Carter JJ, Whelan RL. The immunologic consequences of laparoscopy in oncology. Surg Oncol Clin N Am. 2001 Jul;10(3):655-77.
Background: PubMed 10501289Tashiro T, Yamamori H, Takagi K, Hayashi N, Furukawa K, Nitta H, Toyoda Y, Sano W, Itabashi T, Nishiya K, Hirano J, Nakajima N. Changes in immune function following surgery for esophageal carcinoma. Nutrition. 1999 Oct;15(10):760-6. doi: 10.1016/s0899-9007(99)00151-3.
Background: PubMed 10825740Downing JE, Miyan JA. Neural immunoregulation: emerging roles for nerves in immune homeostasis and disease. Immunol Today. 2000 Jun;21(6):281-9. doi: 10.1016/s0167-5699(00)01635-2.
Background: PubMed 11121511Elenkov IJ, Wilder RL, Chrousos GP, Vizi ES. The sympathetic nerve--an integrative interface between two supersystems: the brain and the immune system. Pharmacol Rev. 2000 Dec;52(4):595-638.
Individual participant dataSharing planned: No

Related trials for Lung Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing General anesthesia alone and Combined epidural-general anesthesia in people with Lung Cancer and Thoracic Surgery, run by Peking University First Hospital at 1 site 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 3 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: finished, as of the sponsor's last update on 27 Aug 2020. 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 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

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?

Recurrence-free survival after surgery. (time frame: Up to 4 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 NCT02801409, which also lists 42 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 27 Aug 2020.