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AzTrials

Stomach NeoplasmsPhase 3NCT04351867

A Clinical Trial of Two Adjuvant Chemotherapy Regimens for Postoperative Gastric Cancer

A Phase 3 study testing docetaxel plus oxaliplatin and capecitabine and oxaliplatin plus capecitabine in people with Stomach Neoplasms, run by LiNing 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study was a prospective, randomized, controlled phase III clinical study to evaluate the efficacy and safety of docetaxel plus oxaliplatin and capecitabine versus oxaliplatin plus capecitabine in the treatment of gastric or gastroesophageal junction adenocarcinoma with postoperative pathological stage IIIB and… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Stomach Neoplasms
What is being tested?
docetaxel plus oxaliplatin and capecitabine and oxaliplatin plus capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
196 participants
Where
1 siteChina
Study dates
Sep 2020to Jun 2024
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have signed the informed consent and can comply with the visit and related procedures stipulated in the program
  • Age ≥18 years old and ≤75 years old
  • D2 radical resection was performed within 21-60 days before the beginning of the first cycle of chemotherapy in this clinical study
  • Preoperative neoadjuvant chemotherapy was not performed and Gastric and gastroesophageal junction adenocarcinoma (including signed-ring cell carcinoma, mucinous adenocarcinoma, and hepatoid adenocarcinoma) at stage IIIB and IIIC were confirmed by postoperative pathological staging. Note: the presence of distant metastases should be confirmed by a CT or MRI scan.ECT should be performed if bone metastases are suspected.If peritoneal metastases are suspected, laparoscopy should be performed
  • Postoperative ECOG score was 0 or 1
  • Leukocyte ≥ 4×109/L, platelet ≥ 100×109/L without blood transfusion, neutrophil absolute value (ANC) ≥ 1.5×109/L without granulocyte stimulating factor treatment, and hemoglobin ≥ 90 g/L
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  • Bilirubin ≤ 1.5 times of the upper limit of normal value, glutamic oxalacetic transaminase and glutamic-pyruvic transaminase ≤ 2.5 times of the upper limit of normal value
  • Serum creatinine ≤ 1.5 times the upper limit of normal value, or GFR>45 ml/min
  • Serum albumin ≥ 25 g/L (2.5g /dL)
  • INR or PT ≤ 1.5 times ULN
  • Hepatitis b surface antigen positive patients need to be tested for hepatitis b DNA virus quantitative detection, only < the upper limit of the normal detection value can be included in the group, and should long-term use of anti-hepatitis b drugs
  • Tumor specimens can be provided for consultation (if the patient's surgical specimen comes from another hospital), protein and gene testing

Who cannot join

  • Postoperative wound healing is poor and chemotherapy is not appropriate to start
  • Recurrent patients or suspected peritoneal metastases after radical surgery
  • Known DPD enzyme deficiency
  • Allergy to, or history of severe allergy to, or contraindication to any of the experimental drugs or its excipients
  • Patients who are expected to require major surgery during the study period
  • Congenital pulmonary fibrosis, drug-induced pneumonia, organized pneumonia, or CT-confirmed active pneumonia
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  • Tested positive for HIV
  • Active hepatitis b or c
  • Only liquid diet was allowed after the operation, with BMI <18kg/m2
  • Uncontrolled pain
  • A history of antitumor drug therapy other than radical surgery
  • Severe infection in the active stage or with poor clinical control
  • Use of hormones is contraindicated
  • Severe cardiovascular disease, myocardial infection or cerebrovascular accident, arrhythmia, unstable angina pectoris within 3 months before the trial
  • Uncontrollable increase in blood pressure or blood sugar
  • A history of other malignancies within 5 years, except for carcinoma in situ of the cervix, non-melanoma skin cancer, or stage I uterine cancer
  • Distant metastases are known
  • Peripheral neuropathy ≥ NCI CTCAE grade 2
  • Serum albumin < 2.5 g/dL
  • Chronic enteritis
  • Any other disease for which there is evidence of a need to limit the use of experimental drugs
  • Participate in additional trials up to 30 days before the trial or plan to participate in additional trials while the trial is ongoing
  • Receive other experimental drugs up to 28 days before the start of the trial
  • Women who are pregnant or nursing, or who plan to become pregnant within five months of the end of treatment. Women of childbearing age should receive a blood/urine pregnancy test 7 days before the start of the trial
  • Clinically significant active bleeding
  • Patients who have trouble swallowing tablets
  • Previous allogeneic bone marrow transplant or organ transplant

Trial locations and contacts

1 site in 1 country.

Ning Li, PhD contact

0086-13526501903

lining97@126.com

China1 site

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

    Ning Li, PhD, 0086-13526501903, lining97@126.com

    Ning LI, PhD

Other trials in China

About this study

Official title: The Efficacy and Safety of Postoperative Chemotherapy With Docetaxel Plus Oxaliplatin and Capecitabine Versus Oxaliplatin Plus Capecitabine for Postoperative Pathological Stage IIIB/IIIC Gastric Adenocarcinoma: a Randomised, Phase 3 Trial

This study was a prospective, randomized, controlled phase III clinical study to evaluate the efficacy and safety of docetaxel plus oxaliplatin and capecitabine versus oxaliplatin plus capecitabine in the treatment of gastric or gastroesophageal junction adenocarcinoma with postoperative pathological stage IIIB and IIIC.

Read the detailed description

In 2019, CSCO guidelines grade I recommend gastric or gastroesophageal junction adenocarcinoma patients, after D2 R0 resection, whose postoperative pathological stage was III treated with XELOX as an adjuvant chemotherapy. However, some retrospective clinical studies in China suggest that the 3-year DFS rate of XELOX program as an adjuvant postoperative chemotherapy program is still low, and the risk of recurrence is higher for patients with postoperative pathological stage IIIB/IIIC.In recent years, the success of the JACCRO GC-07 trial has provided evidence for the value of Taxoids in postoperative adjuvant therapy of gastric cancer. In the FLOT4 trial, the FLOT improved the DFS rate by 3 years compared with the ECF/ECX. At present, there is no clinical study data to prove whether the combined three-drug regimen can further reduce the risk of postoperative recurrence and improve the treatment effect compared with oxaliplatin combined capecitabine two-drug regimen for patients with high postoperative recurrence risk (patients with postoperative pathological stage IIIB/IIIC). Therefore, the investigators carried out this trial.

Being tested
docetaxel plus oxaliplatin and capecitabine, oxaliplatin plus capecitabine
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • docetaxel plus oxaliplatin and capecitabineDrug

    Also called Three medicine combined

    docetaxel 50mg/㎡ ivgtt. d1+oxaliplatin 100mg/㎡ ivgtt. d1+capecitabine 1000mg/㎡ bid p.o. d1-d14 q21d

  • oxaliplatin plus capecitabineDrug

    Also called Two medicine combined

    oxaliplatin 130mg/㎡ ivgtt. d1+capecitabine 1000mg/㎡ bid p.o. d1-d14 q21d

Study groups in NCT04351867
Study groupRoleWhat they receive
experimental groupExperimentaldocetaxel plus oxaliplatin and capecitabine
Receives: Drug: docetaxel plus oxaliplatin and capecitabine
control groupActive comparatoroxaliplatin plus capecitabine
Receives: Drug: oxaliplatin plus capecitabine

What is being measured

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

  1. disease free survival

    From the date of randomization until the date of the first recorded disease recurrence, metastasis or death from any cause, whichever came first.

    Measured: up to three years.

Secondary outcomes (3)

  1. overall survival

    From the date of randomization until the date of the first recorded death from any cause. For subjects lost to follow-up prior to death, the last follow-up time is usually calculated as the time of death.

    Measured: up to three years.

  2. Adverse reaction

    Adverse reaction will be assessed by NCI CT CAE v5.0.

    Measured: up to three years.

  3. Assessment of life quality

    Quality of life will be assessed using The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Cancer (QLQ-C30) and the site-specific module for gastric cancer (QLQ-STO22) . These tables will be usde together to assessed the quality of life of the patients. The higher the score, the worse the quality of life.

    Measured: up to three years.

Timeline

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

  1. First posted17 Apr 2020
  2. Study startSep 2020 (estimated)
  3. Primary completionJun 2024 (estimated)
  4. Study completionJun 2024 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
196 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04351867
Sponsor's protocol ID
GC202001
Status last verified
Jul 2020
First submitted
27 Mar 2020
Last updated
16 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Raw data

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing docetaxel plus oxaliplatin and capecitabine and oxaliplatin plus capecitabine in people with Stomach Neoplasms, run by LiNing 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 12 inclusion and 27 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 16 Jul 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.

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?

Contact Ning Li, PhD (0086-13526501903, lining97@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

disease free survival (time frame: up to three years.). 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 NCT04351867.

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 16 Jul 2020; AzTrials last refreshed its copy on 8 Nov 2026.

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