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Trial of Adjuvant Chemotherapy for High Risk Gastric Cancer Patients

This study is currently recruiting participants.
Verified May 2012 by Tianjin Medical University Cancer Institute and Hospital
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier:
NCT01618474
First received: May 27, 2012
Last updated: June 11, 2012
Last verified: May 2012
History of Changes
  Purpose

This trial is going to evaluate the efficacy and safety of two regimens of DX (docetaxel plus capecitabine)and XELOX (oxaliplatin plus capecitabine)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.


Condition Intervention Phase
Stomach Cancer
 Drug: DX
Drug: XELOX
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Randomized Controlled Trial of Adjuvant Chemotherapy for High Risk Gastric Cancer Patients (IIIb-IIIc)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tianjin Medical University Cancer Institute and Hospital:

Primary Outcome Measures:
  • disease free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    OS was defined as the length of time from the date of randomization to the date of death of vaious reasons

  • CTC negative conversion rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    CTC negative conversion rate was defined as the proportion of the patients whose positive circulating tumor cell turns to be negative after adjuvant chemotherapy


Estimated Enrollment: 100
Study Start Date: May 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DX
DX: Docetaxel 60mg/m2, intravenous infusion, day 1; Capecitabine 1000mg/m2, oral administration, twice a day, day1-14; 3 weeks a cycle for 8 consecutive cycles.
 Drug: DX
Docetaxel 60mg/m2, intravenous infusion, day 1; Capecitabine 1000mg/m2, oral administration, twice a day, day1-14; 3 weeks a cycle for 8 consecutive cycles.
Other Names:
  • Docetaxel
  • Xeloda
Active Comparator: XELOX
XELOX: oxaliplatin 130mg/m2, intravenous infusion, day 1; Capecitabine 1000mg/m2, oral administration, twice a day, day 1-14, 3 weeks a cycle for 8 consecutive cycles
 Drug: XELOX
oxaliplatin 130mg/m2, intravenous infusion, day 1; Capecitabine 1000mg/m2, oral administration, twice a day, day 1-14, 3 weeks a cycle for 8 consecutive cycles
Other Names:
  • Eloxatin
  • XEloda

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01618474

Contacts
Contact: Dingzhi Huang, M.D. +86-22-23340123-1031 dingzhih72@163.com

Locations
China, Tianjin
Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital Recruiting
Tianjin, Tianjin, China, 300060
Contact: Dingzhi Huang, M.D.     +86-22-23340123-1031     dingzhih72@163.com    
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
Investigators
Principal Investigator: Dingzhi Huang, M.D. Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital
  More Information

No publications provided

Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT01618474     History of Changes
Other Study ID Numbers: CIH-HDZ-201205001
Study First Received: May 27, 2012
Last Updated: June 11, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Tianjin Medical University Cancer Institute and Hospital:
gastric cancer
adjuvant chemotherapy

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Adjuvants, Immunologic
Docetaxel
 Capecitabine
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013