A Phase II Randomized Controlled Trial of Adjuvant Chemotherapy for High Risk Gastric Cancer Patients (IIIb-IIIc)
18 Years
N/A
Both
Stomach Cancer
Trial Information
A Phase II Randomized Controlled Trial of Adjuvant Chemotherapy for High Risk Gastric Cancer Patients (IIIb-IIIc)
Operation is the only curative treatment for gastric cancer patients. However, the rate of
recurrence is high up to 60%. The 5 year's overall survival of patient at stage IIIb or more
advanced stage is still poor and approximately 8-28%. Adjuvant chemotherapy is critical for
improving efficacy further. Unfortunately, the optimal adjuvant regimen is not identified
yet. The standard adjuvant treatments of American and European patients are not accepted
widely in Asia area because of different operation procedure and patient's tolerability.
Results of two critical trials indicated that S-1 alone as Japanese standard adjuvant
chemotherapy could not improve the survival of stage IIIb advanced stage gastric cancer
patients while the Korean standard regimen XELOX could. This implied that the more intensive
chemotherapy must be used for the patients with higher risk of relapse. The proportion of
the stage IIIb-IIIc Chinese gastric cancer patients is much larger than that of Japan and
Korean. However, no randomized trial focusing on the extremely high risk of relapse stage
IIIb and stage IIIc patients has been performed, and the standard adjuvant chemotherapy
regimen is not clear and needs to be investigated.
Docetaxel based combination is one of the most effective regimens for advanced gastric
cancer. The combination of docetaxel and 5-FU was found to have a similar efficacy to ECF
regimen along with milder toxicity. Capecitabine has been proved to be a good alternative to
infusional 5-FU. So, docetaxel plus capecitabine seems to be a promising adjuvant regimen
for high risk stage IIIb-IIIc gastric cancer patients. But it still needs to be verified.
This trial is going to evaluate the efficacy and safety of two regimens of DX and XELOX as
adjuvant chemotherapy for stage IIIb-IIIc gastric cancer patients after curative D2/D2+
operation, and to investigate the optimal adjuvant regimen for such extremely high risk
patients.
Inclusion Criteria:
- a post operation histologically confirmed gastric or esophagogastric junction
adenocarcinoma;
- curative D2 or D2+ operation had been performed, and the pathological stage post
operation was verified as IIIb or IIIc;
- no adjuvant chemotherapy before or after operation;
- Karnofsky performance status scale ≥ 70;
- prior adjuvant chemotherapy that did not include taxanes and S-1;
- white blood count ≥ 3,500/mm3, absolute neutrophil count ≥ 1,500/mm3, platelet count
≥ 100,000/mm3, hemoglobin count ≥ 90 g/dL, serum bilirubin level < 1.5 of the upper
limit of normal (ULN) for the institution, aspartate aminotransferase, alanine
aminotransferase and alkaline phosphatase ≤ 2.5 ULN, serum albumin ≥ 30g/L, serum
creatinine ≤ 1.5 ULN; and
- normal cardiac function with no severe heart disease.
Exclusion Criteria:
Major exclusion criteria were as follows:
- pregnancy or breast feeding;
- past history of allergy to taxanes, platinum and 5-fluorouracil or their analogues;
- radiotherapy for all measurable target lesions;
- obstructive bowel disease;
- past history of other cancers except for cured non-melanoma skin cancer or cervical
cancer; and
- concomitant treatment with other anticancer drugs.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
disease free survival
Outcome Description:
DFS was difined as the length of time from the date of randomization to the date of first documentation of relapse of gastric cancer or any other type of cancer or death.
Outcome Time Frame:
3 years
Safety Issue:
No
Principal Investigator
Dingzhi Huang, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital
Authority:
China: Food and Drug Administration
Study ID:
CIH-HDZ-201205001
NCT ID:
NCT01618474
Start Date:
May 2012
Completion Date:
May 2015
Related Keywords:
- Stomach Cancer
- gastric cancer
- adjuvant chemotherapy
- Stomach Neoplasms
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