Second-line Therapy Versus Supportive Care for Pretreated Advanced Gastric Cancer
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ClinicalTrials.gov Identifier: NCT00821990 |
Recruitment Status :
Completed
First Posted : January 14, 2009
Last Update Posted : January 20, 2012
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Condition or disease | Intervention/treatment | Phase |
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Advanced Gastric Cancer | Drug: Chemotherapy Other: Best supportive care | Phase 3 |
Fluoropyrimidine and/or platinum-based chemotherapy is now regarded as a standard first-line treatment in AGC patients because it has shown superiority in terms of response rate and time to disease progression compared with 5-FU monotherapy and other combinations in phase III trials. Despite the lack of evidence for benefit associated with administering salvage chemotherapy, it is a common practice to offer further chemotherapy for AGC patients after first-line failure. For patients who failed after fluoropyrimidine and platinum, taxanes (paclitaxel or docetaxel) and irinotecan have been evaluated extensively in the second-line setting.
Currently, there is no evidence that SLC in patients with AGC will result in substantial prolongation of survival and there is potential for toxicity from the treatment.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Patient Preference Randomized Phase III Clinical Trial of Second-line Chemotherapy (SLC) in Advanced Gastric Cancer (AGC) Patients Pretreated With Both Fluoropyrimidines and Platinum |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | September 2010 |
Actual Study Completion Date : | June 2011 |

Arm | Intervention/treatment |
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Active Comparator: Chemotherapy
Eligible patients will be first offered randomization. If willing to participate RCT, the patient will be randomized to chemotherapy or best supportive care. If patients refuse to participate in RCT, but nevertheless agree to receive treatment of their preferences, they are offered their treatment of choice (chemotherapy or supportive care).
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Drug: Chemotherapy
The administration of chemotherapy regimen (docetaxel or irinotecan) will be determined at the discretion of investigator, and depends on the patient's previous chemotherapy. Other: Best supportive care It includes nutritional support, analgesics, antibiotics, antiemetics, transfusions, or any other symptomatic therapy (with the exception of cytotoxic chemotherapy) and/or assistance of a psychological support. Localized radiotherapy to alleviate symptoms such as pain is allowed provided that the total dose delivered is in a palliative range. |
Active Comparator: Supportive care
Eligible patients will be first offered randomization. If willing to participate RCT, the patient will be randomized to chemotherapy or best supportive care. If patients refuse to participate in RCT, but nevertheless agree to receive treatment of their preferences, they are offered their treatment of choice (chemotherapy or supportive care).
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Other: Best supportive care
It includes nutritional support, analgesics, antibiotics, antiemetics, transfusions, or any other symptomatic therapy (with the exception of cytotoxic chemotherapy) and/or assistance of a psychological support. Localized radiotherapy to alleviate symptoms such as pain is allowed provided that the total dose delivered is in a palliative range. |
- Survival [ Time Frame: 1 year after last patient entered ]

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Ages Eligible for Study: | up to 75 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- aged 75 year or younger
- advanced gastric cancer
- ECOG performance status 0 or 1
- previous failure after chemotherapy with fluoropyrimidine and platinum
- adequate major organ functions
Exclusion Criteria:
- severe concurrent illness and/or active infection
- previously treated with taxanes and irinotecan
- active CNS metastases
- pregnant or lactating women
- who have not recovered from prior treatments

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): NCT00821990
Korea, Republic of | |
Samsung Medical Center | |
Seoul, Korea, Republic of, 135 710 |
Principal Investigator: | Se Hoon Park, MD | Samsung Medical Center, Seoul, Korea |
Responsible Party: | Se Hoon Park, MD, Samsung Medical Center |
ClinicalTrials.gov Identifier: | NCT00821990 |
Other Study ID Numbers: |
2008-08-055 |
First Posted: | January 14, 2009 Key Record Dates |
Last Update Posted: | January 20, 2012 |
Last Verified: | January 2012 |
Failed after previous chemotherapy |
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases |