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Sponsored by: |
National Cancer Center, Korea |
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Information provided by: | National Cancer Center, Korea |
ClinicalTrials.gov Identifier: | NCT00515190 |
Randomized phase II study designed to evaluate the efficacy and safety of continuous S-1 plus oxaliplatin versus intermittent S-1 plus oxaliplatin as first-line therapy in patients with recurrent and/or metastastic gastric carcinoma. Within 2 weeks of the end of induction chemotherapy of 6 cycles with S-1 plus oxalipatin, patients who don't experience progression will be randomized to the continuous S-1 plus oxaliplatin arm or the intermittent S-1 plus oxaliplatin arm in a 1:1 ratio.
Condition | Intervention | Phase |
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Stomach Neoplasms |
Drug: S-1,oxaliplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Phase II Study of Continuous or Intermittent S-1 Combined With Oxaliplatin in Recurrent or Metastatic Gastric Carcinoma |
Estimated Enrollment: | 198 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
(continuous):S-1 plus oxalipatin will be continued until disease progression, unacceptable toxicity or consent withdrawal.
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Drug: S-1,oxaliplatin
Arm A (continuous arm): S-1 80mg/m2/d p.o. twice daily(q 12-h)on D1(evening)-D15(morning)plus oxaliplatin 130mg/m2 IV(in the vein)on D1 every 3 weeks, until disease progression, unacceptable toxicity, or consent withdrawal. Arm B (intermittent arm):Treatment will be stopped after the initial 6 cycles of S-1 plus oxaliplatin, and then S-1 plus oxaliplatin will be resumed at the disease progression during follow-up, as the same dose as the last chemotherapy of initial 6 cycles.
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B: Active Comparator
(intermittent arm): Treatment will be stopped after the initial 6 cycles of S-1 plus oxaliplatin, and then S-1 plus oxaliplatin will be resumed at the disease progression during follow-up, as the same dose as the last chemotherapy of initial 6 cycles.
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Drug: S-1,oxaliplatin
Arm A (continuous arm): S-1 80mg/m2/d p.o. twice daily(q 12-h)on D1(evening)-D15(morning)plus oxaliplatin 130mg/m2 IV(in the vein)on D1 every 3 weeks, until disease progression, unacceptable toxicity, or consent withdrawal. Arm B (intermittent arm):Treatment will be stopped after the initial 6 cycles of S-1 plus oxaliplatin, and then S-1 plus oxaliplatin will be resumed at the disease progression during follow-up, as the same dose as the last chemotherapy of initial 6 cycles.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Prior and/or current history of peripheral neuropathy
Contact: Sook Ryun Park, M.D. | +82-31-920-1609 | sukryun73@ncc.re.kr |
Contact: Se Youn Jang, M.S. | +82-+31-920-0667 | jj96smc@naver.com |
Korea, Republic of, Gyeonggi | |
National Cancer Center Korea | Recruiting |
Goyang, Gyeonggi, Korea, Republic of | |
Contact: Sook Ryun Park, M.D. +82-31-920-1609 sukryun73@ncc.re.kr | |
Contact: Se Youn Jang, M.S. +82-31-920-0667 jj96smc@naver.com | |
Sub-Investigator: Neo Kyenong Kim, M.D.Ph.D | |
Sub-Investigator: Young Iee Park, M,D.Ph.D | |
Sub-Investigator: Jong Seok Lee, M.D. | |
Sub-Investigator: Byung-Ho Nam, M.D.Ph.D | |
Sub-Investigator: Young-Ho Yun, M.D. |
Principal Investigator: | Sook Ryun Park, M.D. | National Cancer Center, Korea |
Responsible Party: | National Cancer Center, Korea ( Sook Ryun Park, M.D. ) |
Study ID Numbers: | NCCCTS-07-265, 82-31-920-1609 |
Study First Received: | August 10, 2007 |
Last Updated: | December 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00515190 History of Changes |
Health Authority: | Korea: Food and Drug Administration |
Stomach Neoplasms Secondary Combination chemotherapy S-1 oxaliplatin |
Oxaliplatin Stomach Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Stomach Neoplasms |
Neoplasm Metastasis Gastrointestinal Neoplasms Stomach Cancer Recurrence Carcinoma |
Oxaliplatin Neoplasms Stomach Diseases Digestive System Diseases Neoplasms by Site Digestive System Neoplasms |
Antineoplastic Agents Gastrointestinal Diseases Therapeutic Uses Stomach Neoplasms Gastrointestinal Neoplasms Pharmacologic Actions |