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

NCT01558947 | Unknown Phase 2 DMC

• 1 other identifier: PC-AGC-01
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastric Cancer

Keywords

gastric cancer; Peri-operative chemotherapy

Outcome Measures

Primary Outcomes (1)

• the relapse-free survival time/rate

  3 years

Study Arms (2)

chemotherapy with ECX

EXPERIMENTAL

chemotherapy with ECX

Drug: Peri-operative chemotherapy of ECX

chemotherapy with XP

EXPERIMENTAL

chemotherapy with XP

Drug: Peri-operative chemotherapy of XP

Interventions

Peri-operative chemotherapy of ECX DRUG

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

chemotherapy with ECX

Peri-operative chemotherapy of XP DRUG

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

chemotherapy with XP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• xiangdong Cheng, MD

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

xiangdong Cheng, MD

CONTACT

+86 571 88122516; abdsurg@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2012
• First Posted: March 20, 2012
• Study Start: January 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: June 1, 2013
• Last Updated: March 20, 2012

Record last verified: 2012-03

Locations

CN (1)