Irinotecan and capecitabine with concurrent chemoradiotherapy for unresectable advanced gastric carcinoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-ONC-13003949

Enrollment

Unknown

Registered

2013-11-27

Start date

2011-09-08

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unresectable advanced gastric carcinoma

Interventions

one:Irinotecan and capecitabine with concurrent chemoradiotherapy

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Written informed consent; 2. Age > 18; Male or Female; 3. Minimum life expectancy of 3 months; 4. ECOG 0-2; 5. Histologically proven gastric adenocarcinoma; Stage T2-4 with or with any positive LN (AJCC 2010), No distant metastasis(M0); unresectable; 6. Adequate bone marrow functions in one week (WBC >/=4.0*10^9/L, GRAN>/=2.0*10^9/L, Hb>/=90g/L, PLT>/=100*10^9/L); Adequate renal functions(serum creatinine /=30g/L, serum bilirubin </=1.5*ULN (Excluding patients with biliary obstruction or cholangitis), AST/ALT </=2.5 times; 7. Previous no radiotherapy for stomach, or radiotherapy for non-target organ has been completed at least 4 weeks before inclusion,no targeted therapies; 8. Patients conforming the upon conditions after laparotomy, postoperative jaundice and bowel obstruction were relieve after surgery; 9. pregnant negative women (chosen).

Exclusion criteria

Exclusion criteria: 1. Stage T1N0 or with distant metastasis; 2. active gastrointestinal bleeding; 3. Patient who has had the malignant tumor at present or before, except for cured basal cell carcinoma of skin or Cervical carcinoma in situ; 4. The existence of the peripheral nervous system disorders or significant neurological disorders and a history of central nervous system disorders, sucn as patients with Alcoholism, drug addiction or mental illness; 5. concurrent serious systemic disease or complications; 6. Patients associated with upper gastrointestinal dysfunction,or dysphagia that may influence the absorption of capecitabine; or unable to take oral medication; 7.Pregnant or lactating woman, or child-bearing period woman with pregnancy tests positive or without pregnancy tests before receiving treatment; postmenopausal women must be no menstrual periods for at least 12 months; 8. Patients who are unwilling or unable to comply with the study protocol.

Design outcomes

Primary

Measure	Time frame
PFS;	—

Secondary

Measure	Time frame
ORR;OS;	—

Countries

China

Contacts

Public ContactTao Zhang

Cancer Center of Union Hospital, Wuhan

13377876066@163.com+86 13808640033

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026