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Feasibility study of postoperative concurrent radiotherapy and chemotherapy for locally advanced gastric cancer patients

Phase I Study to Determine MTD of Capecitabine with Concurrent Radiation Therapy for Locally Advanced Gastric Cancer after D2 Resection

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-TNC-10000787
Enrollment
Unknown
Registered
2010-02-21
Start date
2008-01-01
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

Locally Advanced Gastric Cancer

Interventions

1:From the first day of radiotherapy, Capecitabine was administered 600 mg/m2 twice a day (b.i.d.) orally (PO), d1–14, every 21 days, 2 cycles in total.
2:From the first day of radiotherapy, Capecitabine was administered 700 mg/m2 twice a day (b.i.d.) orally (PO), d1–14, every 21 days, 2 cycles in total.
3:From the first day of radiotherapy, Capecitabine was administered 800 mg/m2 twice a day (b.i.d.) orally (PO), d1–14, every 21 days, 2 cycles in total.
4:From the first day of radiotherapy, Capecitabine was administered 850 mg/m2 twice a day (b.i.d.) orally (PO), d1–14, every 21 days, 2 cycles in total.
5:From the first day of radiotherapy, Capecitabine was administered 900 mg/m2 twice a day (b.i.d.) orally (PO), d1–14, every 21 days, 2 cycles in total.

Sponsors

Peking University School of Oncology, Beijing Cancer Hospital & Institute
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. All patients were 18-70 years old, male or female, and enrolled within 3 months of surgery; 2. Postoperative histologically confirmed locally advanced gastric cancer after D2 resection, including T3, T4 and any T, N1-3, M0; 3. Kps>=70, No more than 10% weight loss within past 6 months, life expectancy >12 months and tolerent radiation; 4. No main organ function disable, Leucocyte>= 4000/uL, a neutrophil count>=1500/uL, PLT >=10000/uL, hemoglobin>=10g/dL, CR<=1.0 upper limit of normal, TB<=1.5 upper limit of normal, AST and ALT<=2.5 upper limit of normal, AKP<=5 upper limit of normal; 5. No upper abdominal chest RT history; 6. Patients shoud understand and sign the Informed consent; 7. No history of allergy to 5-fluorouracil.

Exclusion criteria

Exclusion criteria: 1. Patients are receiving other anti-cancer therapy, and pregnant and lactating women; 2. Patients with a second primary tumor other than non-melanoma skin cancer or in situ cervical carcinoma; 3. Any chemotherapy contraindications such as active infection, uncontrolled diabetes, prior allergic reaction to fluorouracil and other serious disease, for example myocardial infarction; 4. Uncontrolable madman psychopath; 5. Investigator consider inappropriate patients for the study.

Design outcomes

Primary

MeasureTime frame
response rate, toxicity;

Countries

China

Contacts

Public ContactGuangying Zhu
zgypu@yahoo.com.cn+86 010 88196120

Outcome results

None listed

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