Taxanes or Platinum in Combination With Capecitabine Followed by Capecitabine Alone as First Line Treatment for Patients With Advanced Adenocarcinoma of Stomach or Esophagogastric Junction
This study is currently recruiting participants.
Verified November 2011 by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Sponsor:
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Information provided by (Responsible Party):
Xu jianming, The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
ClinicalTrials.gov Identifier:
NCT01468389
First received: November 4, 2011
Last updated: November 8, 2011
Last verified: November 2011
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Purpose
The purpose of this study is to investigate whether Taxanes or Platinum Plus Capecitabine With Capecitabine Maintenance Treatment as 1st line treatment in he advanced gastric cancer is effective and safe.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastric Cancer |
Drug: Capecitabine Drug: capecitabine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Multicenter Phase III Study:Taxanes or Platinum in Combination With Capecitabine Followed by Capecitabine Alone vs.Taxanes or Platinum Combined With Capecitabine in Advanced Adenocarcinoma of the Stomach or Esophagogastric Junction. |
Resource links provided by NLM:
Further study details as provided by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences:
Primary Outcome Measures:
- Progression free survival [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Tumor response rate [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- disease control rate [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- overall survival [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]
- adverse events [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 300 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Taxanes or Platinum in combination with Capecitabine
The patients will received chemotherapy combining capecitabine with platinum or taxanes until progression.
|
Drug: Capecitabine
900-1000mg/m2 bid, days 1-14, every 3 weeks
|
|
Experimental: chemotherapy followed by capecitabine alone
The patients who has received 4 cycle chemotherapy combining capecitabine with platinum or taxanes and the result was SD or CR or PR,will be given capecitabine alone until progression.
|
Drug: capecitabine
Dosing schedule: 900-1000mg/m2 bid, days 1-14, every 3 weeks Maintenance dosing schedule: 1000-1250mg/m2 bid, days 1-14, every 3 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Having signed informed consent
- Age≥ 18 years old
- Histologically confirmed gastric adenocarcinoma
- Unresectable recurrent or metastatic disease
- Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months
- Previous chemotherapy with oxaliplatin or cisplatin or paclitaxel or docetaxel, if applicable, more than 12 months.
- Measurable disease according to the RECIST criteria
- ECOG performance status ≤2
- Life expectancy of ≥3 month
- No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks
- ALT and AST≤2.5 times ULN (≤5 times ULN in patients with liver metastases) Serum albumin level ≥3.0g/dL Serum creatinine ≤1.5ULN Bilirubin level ≤ 1.5 ULN WBC>3,000/mm3, absolute neutrophil count ≥1500/mm3, platelet>90,000/mm3, Hb>8g/dl
Exclusion Criteria:
- Brain metastasis (known or suspected)
- Previous systemic therapy for metastatic gastric cancer
- Inability to take oral medication
- Previous therapy targeting at angiogenesis or vasculogenesis pathway or other targeted therapy
- Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry
- Allergic constitution or allergic history to any investigating agents.
- Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension.
- Pregnancy or lactation period
- Any investigational agent within the past 28 days
- Other previous malignancy within 5 year
- Pre-existing neuropathy>grade 1
- Legal incapacity
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01468389
Contacts
| Contact: Xu jianming, M.D. | 861051128358 | jmxu2003@yahoo.com |
Locations
| China, Beijing | |
| 307 Hospital of PLA | Recruiting |
| Beijing, Beijing, China | |
| Contact: Xu jianming, M.D. 86-10-66947176 jmxu2003@yahoo.com | |
| Contact: Zhao chuanhua 86-10-66947179 chuanhuazhao@163.com | |
Sponsors and Collaborators
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Investigators
| Principal Investigator: | Xu jianming, M.D. | The Affiliated Hospital of the Chinese Academy of Military Medical Science |
| Principal Investigator: | XU jianming, M.D. | The Affiliated Hospital of the Chinese Academy of Military Medical Science |
More Information
No publications provided
| Responsible Party: | Xu jianming, The Affiliated Hospital of the Chinese Academy of Military Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT01468389 History of Changes |
| Other Study ID Numbers: | AGC001-307PLAH-XJM |
| Study First Received: | November 4, 2011 |
| Last Updated: | November 8, 2011 |
| Health Authority: | China: Ethics Committee |
Keywords provided by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences:
|
Gastric Cancer capecitabine maintenance treatment |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Stomach Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases |
Stomach Diseases Taxane Capecitabine Fluorouracil Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013