Capecitabine and Oxaliplatin Adjuvant Study in Stomach Cancer (CLASSIC)
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|ClinicalTrials.gov Identifier: NCT00411229|
Recruitment Status : Completed
First Posted : December 13, 2006
Last Update Posted : February 20, 2013
- To demonstrate that capecitabine/oxaliplatin as adjuvant chemotherapy is superior to observation alone in terms of 3 year disease-free survival (DFS) rate in chemotherapy-naïve patients who underwent potentially curative resection for gastric cancer.
- To compare the overall survival of surgery and capecitabine/ oxaliplatin as adjuvant therapy versus surgery alone. To evaluate the safety profile of capecitabine/oxaliplatin adjuvant therapy.
|Condition or disease||Intervention/treatment||Phase|
|Stomach Neoplasms||Drug: Capecitabine Drug: Oxaliplatin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1035 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III Study Comparing Adjuvant Chemotherapy Consisting of Capecitabine/Oxaliplatin vs Surgery Alone in Patients With Stage II (T1N2, T2N1, T3N0), IIIa (T2N2, T3N1, T4NO), and IIIb (T3N2) Gastric Adenocarcinoma|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
Active Comparator: 1
Capecitabine + Oxalipatin
1,000 mg/m² twice daily. Film coated tablets of 500 mg, 150mg.
IV infusion, 130mg/m²
|No Intervention: 2|
- Recurrence of the original cancer [ Time Frame: From the beginning to end of the study ]
- Development of a new gastric cancer [ Time Frame: From beginning to end of study ]
- Death due to any cause [ Time Frame: From the beginning to the end of study ]
- Adverse events [ Time Frame: From beginning to end of study ]
- Clinical laboratory tests [ Time Frame: From beginning to end of study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00411229
|Korea, Republic of|
|Seoul, Korea, Republic of|
|Study Director:||Clinical Sciences & Operations||Sanofi|