Capecitabine or Observation for Patients With pT1N+M0 or pT2-3N0M0 Gastric Adenocarcinoma Undergoing R0 Resection

  • STATUS
    Recruiting
  • End date
    Jan 30, 2026
  • participants needed
    768
  • sponsor
    The First Affiliated Hospital of Anhui Medical University
Updated on 24 January 2021
platelet count
fluorouracil
metastasis
gastric adenocarcinoma
neutrophil count
capecitabine
adjuvant therapy
cancer chemotherapy
adenocarcinoma
immunostimulants

Summary

Gastric cancer (GC) is one of the most common and lethal malignancies in Asia. For early (stage T1) GC, it has been found by analyzing surgical specimens that ~5% of cancers have lymph node metastasis. For patients with stage T2-3N0M0 GCs, there is a considerable probability of micro-metastasis. While the US National Comprehensive Cancer Network (NCCN), the Japanese Gastric Cancer Association (JGCA), and the European Society for Medical Oncology (ESMO) guidelines recommend adjuvant therapy for most patients with resected >T1N0 GCs, the recommendations vary regarding postsurgical treatment for patients with stage T1N+M0 or T2-3N0M0 disease. The JGCA guidelines do not recommend postsurgical chemotherapy for this patient population, while the ESMO support the adjuvant treatment. The NCCN has not offered a definitive recommendation on this issue. Through careful literature search, there is not yet randomized report on whether postsurgical chemotherapy benefits survival for patients with resected T1N+M0 or T2-3N0M0 GC. The first-line chemotherapy regimen for GC is fluorouracil plus platinum. Among fluorouracil, platinum is especially favored due to its less frequent and less severe adverse effects. This large multicenter phase III randomized controlled trial is led by Department of Gastrointestinal Surgery, The First Affiliated Hospital of Anhui Medical University, and carried out in multiple Chinese centers, aiming to compare the safety and efficacy of capecitabine monotherapy versus no therapy in the adjuvant setting for patients with stage T1N+M0 or T2-3N0M0 GC undergoing R0 Resection.

Details
Condition Gastropathy, Stomach Discomfort, Gastric Cancer, Gastric Cancer, Stomach Cancer, Stomach Discomfort, Gastric Carcinoma, Stomach Cancer, gastric cancers
Treatment Capecitabine monotherapy
Clinical Study IdentifierNCT03817268
SponsorThe First Affiliated Hospital of Anhui Medical University
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Microscopically-confirmed gastric adenocarcinoma (cardia cancer/adenocarcinoma of the esophagogastric junction)
Cancer stage pT1N+M0 or pT2-3N0M0
Radical R0 resection
Retrieved lymph node number 15
Without hepatic, peritoneal, or other distant metastasis
Aged 18-70 years
No other cancer-directed therapy except primary cancer resection
Good tissue and organ function: white blood cell count 4000/mm3; neutrophil count 1500/mm3; platelet count 100000/mm3; total bilirubin 25.7 mol/L or within 1.5 times the upper threshold; aspartate transaminase (AST) and alanine transaminase (ALT) within 2.5 times the upper threshold; creatinine within 1.25 times the upper threshold; creatinine clearance rate >60 mL/min
No serious cardiovascular or cerebrovascular disease
No concomitant or previous malignancies
Enrolled within 6 weeks after resection
Eastern Cooperative Oncology Group (ECOG) score 2
Clavien-Dindo morbidity score 0-2
Patient informed consent

Exclusion Criteria

The need to take phenytoin or coumarin anti-coagulates
Allergic to capecitabine or fluorouracil
Known DPD activity deficiency (DPYD gene mutation)
Pregnant or breeding women
All others contradictory to the items listed in the Inclusion Criteria
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note