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Advanced Gastric CancerPhase 2NCT03564834

Laparoscopic Versus Open Gastrectomy for Elderly Local Advanced Gastric Cancer Patients

A Phase 2 study testing Laparoscopic gastrectomy and Open gastrectomy in people with Advanced Gastric Cancer, run by Peking University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Gastric cancer is one of the most common malignant tumors worldwide. With the rapid aging of global population, the number of elderly patients with local advanced gastric cancer is increasing. Surgery is the essential treatment for local advanced gastric cancer. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Advanced Gastric Cancer
What is being tested?
Laparoscopic gastrectomy and Open gastrectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteChina
Study dates
23 Aug 2018to 30 Jul 2023
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 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Ambulatory male or female aged 70 and above
  • Karnofsky score≥70%
  • Histologically proven gastric adenocarcinoma in biopsy (including Lauren classification) Proven clinical stage of cT2-4aNanyM0 by baseline ultrasound endoscope, enhanced CT/MRI examination, or diagnostic laparoscopy using Habermann Standards
  • No past chemotherapy or radiotherapy before diagnosis
  • Primary tumor located at stomach, achievable naked-eye complete resection (R0/1) via distal subtotal or total gastrectomy plus lymphadenectomy
  • Haematology and biochemistry index meet the following: hemoglobin≥80g/L, absolute neutrophils count (ANC)≥1.5×109/L, platelet≥100×109/L, ALT、AST≤2.5 times the upper limit of normal value, ALP≤2.5 times the upper limit of normal value, serum total bilirubin<1.5 times the upper limit of normal value, serum creatinine<1 times the upper limit of normal value, serum albumin≥30g/L
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  • Heart and lung function can withstand surgery
  • No severe concomitant disease that leads to survival<3 years
  • Willing and able to comply with study protocol Written agreement consent before enrolment and full aware of the right to quit the study at any time with no loss

Who cannot join

  • Uncontrolled seizure, central nervous system diseases, or mental disorders;
  • Past history of upper abdominal surgery (except for laparoscopic cholecystectomy)
  • Past history of gastric surgery (including diagnosis procedure such as ESD and EMR)
  • Other malignant diseases in 5 years (except for cured skin carcinoma and cervical carcinoma in situ)
  • Clinical severe or active heart diseases, such as symptomatic coronary heart disease, NYHA grade II or above congestive heart failure, severe arrhythmia, or myocardial infarction in 6 months
  • Cerebral hemorrhage or infarction in 6 months
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  • Organ transplant recipients under immunosuppressive therapy
  • Severe uncontrolled repeated infection or other severe uncontrolled concomitant diseases
  • Medium or severe renal damage (creatinine clearance rate≤50ml/min or serum creatinine> upper limit of normal value)
  • Other diseases requiring synchronous surgery
  • Requiring emergent surgery due to oncologic emergent (e.g. bleeding, perforation, obstruction)
  • FEV1<50% of expected value Participated in other studies 4 weeks before the randomization.

Trial locations and contacts

1 site in 1 country.

Fei Shan, MD contact

0086-10-88196606

shanfei@hsc.pku.edu.cn

Ziyu Li, MD contact

0086-10-88196605

ziyu_li@hsc.pku.edu.cn

China1 site, 1 recruiting

  • Peking University Cancer Hospital & Institute

    Beijing, Beijing Municipality, 100142

    Fei Shan, M.D., 86-010-8819-6606, shanfei@hsc.pku.edu.cn

    Ziyu Li, M.D., 86-010-8819-6605, ziyu_li@hsc.pku.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Laparoscopic Versus Open Gastrectomy for Elderly Local Advanced Gastric Cancer Patients: a Phase II Randomized Parallel Controlled Trial

Gastric cancer is one of the most common malignant tumors worldwide. With the rapid aging of global population, the number of elderly patients with local advanced gastric cancer is increasing. Surgery is the essential treatment for local advanced gastric cancer. However, because of the degeneration of physiological organs, cell functions, compensatory ability, immunity, and physiological reserve ability, elderly patients often face great safety issues when having surgery. Therefore, how to treat the elderly patients with local advanced gastric cancer with safe and effective surgery is one of the important problems in the field of gastric cancer treatment. With the introduction of minimally invasive treatment concepts and techniques, the role of laparoscopic radical gastrectomy in the treatment of early gastric cancer, as well as the advantages of trauma control and postoperative accelerated rehabilitation have been confirmed, however, there is still a lack of sufficient high-level clinical evidence in the elderly patients with advanced gastric cancer. The current study therefore aims to evaluate the safety and efficacy of laparoscopic versus open gastrectomy for advanced gastric cancer in elderly patients, using a randomized parallel controlled study design. The investigators hypothesized that laparoscopic gastrectomy is superior to open gastrectomy in terms of perioperative safety for local advanced gastric cancer patients aged 70 and above.

Read the detailed description

Gastric cancer is one of the most common cancer and cause of cancer death worldwide. With the rapid aging of global population, the number of elderly patients with local advanced gastric cancer has been continuously increasing. Surgery is the essential treatment for local advanced gastric cancer. However, elderly patients are at high risk of postoperative complications due to reduced functional reserve and increased comorbidities. Studies have shown that elder patients can have postoperative complication incidence up to 18%-32% and surgery-related mortality rate to 3.8%-9.5%. Therefore, elderly patients usually require more restrict operative injury control compared to the younger population. Surgical safety and effectiveness has become a crucial research focus for local advanced gastric cancer among elderly patients.

Laparoscopic gastrectomy is one of the standard treatments for early gastric cancer and has demonstrated its application value in local advanced gastric cancer. Two recent meta-analysis on observational studies have shown the feasibility of laparoscopic gastrectomy in elderly gastric cancer patients. Compared to conventional open resections, elderly patients may benefit from the advantages of laparoscopic approach such as less trauma, less blood loss, faster bowel movement recovery, earlier food intake, and shorter hospitalization. However, laparoscopic gastrectomy raises issues such as prolonged operation time and disturbance of circulatory and respiratory dynamics by carbon dioxide pneumoperitoneum during the procedure. Nonetheless, all currently available evidence comes from observational studies that are susceptible to bias and evidence on long-term survival is scarce. The investigators therefore proposed to conduct this randomized controlled trial comparing the feasibility and survival benefit of laparoscopic with open gastrectomy for elderly patients with local advanced gastric cancer. The investigators hypothesized that laparoscopic gastrectomy is superior to open gastrectomy in terms of perioperative safety for local advanced gastric cancer patients aged 70 and above.

Being tested
Laparoscopic gastrectomy, Open gastrectomy
Keywords
Elderly patients, Open gastrectomy, Laparoscopic gastrectomy

What participants receive

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

  • Laparoscopic gastrectomyProcedure or surgery

    Patients will receive laparoscopic gastrectomy within one week after randomization.

  • Open gastrectomyProcedure or surgery

    Patients will receive open gastrectomy within one week after randomization.

Study groups in NCT03564834
Study groupRoleWhat they receive
Laparoscopic gastrectomyExperimentalA standard laparoscopic gastrectomy with D2 lymphadenectomy will be performed by two experienced surgeons, according to the Japanese Gastric Cancer Treatment Guidelines 2014 (version 4) and the Japanese Classification of Gastric Carcinoma (3rd English edition).
Receives: Procedure: Laparoscopic gastrectomy
Open gastrectomyActive comparatorA standard open gastrectomy with D2 lymphadenectomy will be performed by two experienced surgeons, according to the Japanese Gastric Cancer Treatment Guidelines 2014 (version 4) and the Japanese Classification of Gastric Carcinoma (3rd English edition).
Receives: Procedure: Open gastrectomy

What is being measured

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

  1. Postoperative complication rate

    Surgery related complications include incision complications (infection, effusion, dehiscence, poor healing), peritoneal effusion or abscess formation, hemorrhage (inside abdominal cavity, inside digestive tract), ileus, anastomotic leakage, anastomotic stenosis, intestinal fistula, lymphatic leakage, pancreatic fistula, gastroparesis, pancreatitis, lung infection, pleural effusion, urinary tract infection, renal failure, liver failure, cardio-cerebrovascular events (both lower extremities thrombosis, pulmonary embolism, myocardial infarction, arrhythmia, cerebral infarction, etc.), and others. Complications will be reported and graded according to the Clavien-Dindo classification of surgical complications.

    Measured: within 30 days after surgery

Secondary outcomes (5)

  1. Length of postoperative hospitalization stay

    Postoperative hospitalization stay refers to the time interval between the day of surgery and discharge, and will be recorded by the investigators.

    Measured: within 30 days after surgery

  2. Postoperative life quality

    Will be assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life questionnaires (i.e. QLQ-C30), which contains both QLQ-STO22 and ELD14 modules. This is a questionnaire developed to assess the generic and disease-specific quality of life for elderly gastric cancer patients by European Organisation for Research and Treatment of Cancer. The Summary Score will be calculated from the mean of scales. Prior to calculating the mean, the symptom scales will need to be reversed to obtain a uniform direction of all scales. The summary score should only be calculated if all of the required scale scores are available (using scale scores based on the completed items, provided that at least 50% of the items in that scale have been completed.

    Measured: one-year after surgery

  3. Three-year overall survival rate

    Overall survival is defined as the time interval from the time of the radical gastrectomy to the date of all-cause death or the last follow-up. Three-year overall survival rate will be calculated using the Kaplan-Meier Methods.

    Measured: Three-year after surgery

  4. Three-year disease-free survival rate

    Disease-free survival is defined as the time interval from the time of the radical gastrectomy to the date of the detection of cancer recurrence or the last follow-up. Three-year disease-free survival rate will be calculated using the Kaplan-Meier Methods.

    Measured: Three-year after surgery

  5. Postoperative pain

    Postoperative pain will be measured using the Numeric Rating Scale (NRS-11) which is an 11-point scale for patient self-reporting of pain. The scale ranges from 0 to 10, with 0 being no pain. Pain level will be graded into four levels for analysis: "0: No Pain", "1-3: Mild Pain", "4-6 Moderate Pain", and "7-10 Severe Pain".

    Measured: within 2 weeks after surgery

Timeline

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

  1. First posted21 Jun 2018
  2. Study start23 Aug 2018
  3. Primary completion30 Jul 2020 (estimated)
  4. Study completion30 Jul 2023 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03564834
Sponsor's protocol ID
SF2018-4-2156
Status last verified
Sep 2018
First submitted
14 May 2018
Last updated
28 Sep 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The deidentified datasets generated during the current study will be publicly available via an appropriate data archive 6 months after the completion of the trial.

Publications

  • Li Z, Shan F, Ying X, Xue K, Ji J. Laparoscopic versus open gastrectomy for elderly local advanced gastric cancer patients: study protocol of a phase II randomized controlled trial. BMC Cancer. 2018 Nov 16;18(1):1118. doi: 10.1186/s12885-018-5041-y.

    PubMed 30445943

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Laparoscopic gastrectomy and Open gastrectomy in people with Advanced Gastric Cancer, run by Peking University 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 9 inclusion and 12 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 28 Sep 2018. 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.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fei Shan, MD (0086-10-88196606, shanfei@hsc.pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative complication rate (time frame: within 30 days 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 NCT03564834, 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 28 Sep 2018.

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