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Status unknownNCT01558947Updated Mar 20, 2012

Peri-operative Chemotherapy With ECX or XP in the Treatment of Advanced Gastric Cancer

A Phase 2 interventional study of Peri-operative chemotherapy of ECX and Peri-operative chemotherapy of XP in Gastric Cancer, sponsored by Zhejiang Cancer Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-03-20.

Sponsored by Zhejiang Cancer Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
2
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the safety and the effect of perioperative chemotherapy in the treatment of advanced gastric cancer.

Read the detailed description

To evaluate the security and the relapse-free survival time/rate(1,2,3 yrs) of perioperative chemotherapy with ECX (epirubicin + cisplatin + capecitabine) and XP (capecitabine + cisplatin)in advanced gastric cancer

02

Conditions studied

  • Gastric Cancer

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Keywords

  • gastric cancer
  • Peri-operative chemotherapy
03

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's planned enrollment of 2 is below the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Zhejiang Cancer Hospital is the lead sponsor of 271 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male and female aged 18 to 70 years old.
  • The preoperative evaluation: gastric cancer patients, ≥ T2 or N +; or staging II, IIIA, IIIB.
  • Karnofsky score ≥ 70, life expectancy > 6 months.
  • Endoscopic biopsy diagnosis of gastric cancer, excluding non-Hodgkin's lymphoma, leiomyosarcoma and other mesenchymal tumors.
  • the blood and biochemical indicators of the subjects must meet the following criteria: Hb ≥ 9 g / dl; WBC ≥ 4,000 / mm3, ≤ 12000 / mm3; PLT ≥ 100,000/mm3; GOT, GPT within twice the institutional limit,serum total bilirubin \< 1.5 times the upper limit of normal, serum creatinine\< 1.25 times the upper limit of normal and creatinine clearance rate ≥ 60ml/min, LVEF ≥ 60%.
  • have not received prior chemotherapy, radiotherapy and biological therapy.
  • signed informed consent.
  • must accept the standard D2 or D2 + radical gastrectomy.
  • with good compliance.

Exclusion criteria

Exclusion Criteria:

  • pregnancy, breast-feeding women.
  • allergy with chemotherapy drugs or metabolic disorder.
  • the history of organ transplants (including bone marrow transplantation and autologous peripheral stem cell transplantation).
  • had long received systemic steroid treatment (Note: short-term users of withdrawal > 2 weeks can be selected.)
  • The existence of the peripheral nervous system disorders or significant neurological disorders and a history of central nervous system disorders.
  • patients with severe infection requires treatment.
  • patients associated with dysphagia, active peptic ulcer, incompleteness intestinal obstruction, active gastrointestinal bleeding, perforation.
  • severe liver disease (such as cirrhosis), kidney disease, respiratory disease or uncontrollable diabetes.
  • with other malignancies which were not cured.
  • EKG abnormalities or heart disease with apparent clinical symptoms, including congestive heart failure, coronary heart disease with symptoms, uncontrollable arrhythmia, hypertension, and heart attack within 12 months or III or IV grade myocardial infarction. Coronary heart disease with symptoms, uncontrollable arrhythmia, hypertension, and heart attack within 12 months or III or IV grade myocardial infarction.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
2 participants (estimated)

Study arms

  • Experimental
    chemotherapy with ECX

    chemotherapy with ECX

    Drug: Peri-operative chemotherapy of ECX

  • Experimental
    chemotherapy with XP

    chemotherapy with XP

    Drug: Peri-operative chemotherapy of XP

Interventions

  • DrugPeri-operative chemotherapy of ECX

    Preoperative chemotherapy of ECX for 3 cycles(Epirubicin 50mg/m2 on day 1; capecitabine 1000mg/m2, 2 times / day, 1 to 14 days; cisplatin 60mg/m2 on day 1, need hydration, 21 day/cycle), operation after 2\~4 weeks, and postoperative chemotherapy of ECX for 3 cycles 4\~6 weeks after surgery.

    Also known as: ECX chemotherapy

  • DrugPeri-operative chemotherapy of XP

    Preoperative chemotherapy of XP for 3 cycles(capecitabine 1000mg/m2, 2 times / day, 1 to 14 days; cisplatin 60mg/m2 on day 1, need hydration, 21 day/cycle), operation after 2\~4 weeks, and postoperative chemotherapy of XP for 3 cycles 4\~6 weeks after surgery.

    Also known as: XP chemotherapy

06

What researchers measure

Primary outcomes

  1. the relapse-free survival time/rate

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
  • Zhejiang Cancer Hospital
    Hangzhou, Zhejiang 310022, China
    • xiangdong Cheng, MD · Contact · abdsurg@hotmail.com · +86 571 88122516
    • xiangdong Cheng, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01558947
Lead sponsor
Zhejiang Cancer Hospital
Responsible party
Sponsor
First posted
Mar 20, 2012
Start date
Jan 2011
Primary completion
Dec 2012 (estimated)
Completion
Jun 2013 (estimated)
Last update
Mar 20, 2012

Study contacts

xiangdong Cheng, MD
Contact
abdsurg@hotmail.com
+86 571 88122516
xiangdong Cheng, MD
principal investigator · Zhejiang Cancer Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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