Chemotherapy Alone Versus Surgery Plus Chemotherapy for Distal Gastric Cancer With One Non-curable Factor
A Prospective,Multicentral,Open-label,Randomized,Controlled,Phase III Clinical Trial of Chemotherapy Alone Versus D2 Gastrectomy and Metastasectomy Plus Chemotherapy for Distal Gastric Cancer With One Non-curable Factor
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Gastric cancer is the fourth most common malignancy worldwide and the second leading cause of cancer-related deaths, with the highest mortality rates reported in East Asia, including China. Many patients are diagnosed at an advanced stage of gastric cancer because of late onset and nonspecific symptoms. The prognosis of patients with advanced gastric cancer with non-curable factors, such as hepatic, peritoneal, or distant lymph node metastases, is poor. Chemotherapy is the standard of care for these patients. Palliative resection or bypass surgery is generally indicated in the presence of major symptoms such as bleeding or obstruction for incurable advanced gastric cancer. The usefulness of gastrectomy and metastasectomy is still unclear.
The REGATTA trial is the first clinical trial to explore the significance of surgery for incurable advanced gastric cancer. However, it concluded an opposite conclusion that gastrectomy followed by chemotherapy did not show any survival benefit compared with chemotherapy alone in advanced gastric cancer with a single non-curable factor. Interestingly, there was a significant interaction between treatment effect and tumor location in subgroup analyses of overall survival. Gastrectomy plus chemotherapy was associated with significantly worse overall survival in patients with upper-third tumors for less chemotherapy cycles. This finding raises the question whether inclusion criteria were restricted to the patients with lower-third tumor, findings of study might have been positive. So we raise this new trail to assess the significance of Gastrectomy and Metastasectomy for Distal Gastric Cancer With One Non-curable Factor.
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 2
- Fas 3
Kontakter och platser
Studiekontakt
- Namn: Dazhi Xu, PHD
- Telefonnummer: (+86) 020-87343737
- E-post: xudzh@sysucc.org.cn
Studieorter
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Tianjin, Kina
- Rekrytering
- Tianjin Medical University Cancer Institute and Hospital
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Kontakt:
- Rupeng Zhang
- Telefonnummer: 13920561244
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Anhui
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Anqing, Anhui, Kina
- Rekrytering
- Anqing Municipal Hospital
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Kontakt:
- Yaming Zhang
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Kontakt:
- Daibin Tang
- Telefonnummer: 13865176528
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Hefei, Anhui, Kina
- Rekrytering
- The First Affiliated Hospital of Anhui Medical University
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Kontakt:
- Aman Xu
- Telefonnummer: 13705695470
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Kontakt:
- Fei Zhong
- Telefonnummer: 18226616729
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Hefei, Anhui, Kina
- Rekrytering
- Anhui Provincial Hospital
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Kontakt:
- Xuhui Zhao
- Telefonnummer: 18963789289
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Kontakt:
- Yifu He
- Telefonnummer: 13485691976
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Wuhu, Anhui, Kina
- Rekrytering
- First Affiliated Hospital of Wannan Medical College
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Kontakt:
- Lianghui Shi
- Telefonnummer: 13956159006
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Guangdong
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Guangzhou, Guangdong, Kina
- Rekrytering
- Yuebei People's Hospital
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Kontakt:
- Tao Tao Zhang
- Telefonnummer: 13500206389
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Guangzhou, Guangdong, Kina
- Rekrytering
- Cancer center of Sun Yat-sen University
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Kontakt:
- Dazhi Xu
- Telefonnummer: 86(020)87343737
- E-post: xudzh@sysucc.org.cn
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Kontakt:
- Youqing Zhan
- Telefonnummer: 86(020)87343910
- E-post: Zhanyq@sysucc.org.cn
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Jiangxi
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Nanchang, Jiangxi, Kina
- Rekrytering
- Jiangxi Provincial Cancer Hospital
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Kontakt:
- Huamin Rao
- Telefonnummer: 13879100685
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Zhejiang
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Hangzhou, Zhejiang, Kina
- Rekrytering
- Second Affiliated Hospital, School of Medicine, Zhejiang University
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Kontakt:
- Li Chen
- Telefonnummer: 13958092350
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Lower age limit of research subjects 18 years old and upper age limit of 75 years old.
- PS (ECOG) of 0 or 1.
- Without any other malignancies.
- Written informed consent from the patient.
- Standard gastrectomy with D2 lymphadenectomy for primary cancer
A single non-curable factor was defined by preoperative CT :
hepatic metastasis (H1 or H2; maximum diameter ≤4 cm, number ≤4); peritoneal metastasis (R0 or R1 resection) para-aortic lymph node metastasis （number ≤4) ovarian metastasis adrenal metastasis renal metastasis
- No contraindications to chemotherapy, including normal peripheral blood routine, liver and kidney function and electrocardiogram （WBC≥4.0 x 109 /L, NEU≥1.5 x 109 /L,PLT≥100 x 109 /L and HGB≥90g/L)
Exclusion Criteria:
- Female in pregnancy or lactation.
- Supraclavicular lymph nodes metastases，lung and bone metastases.
- Massive ascites or cachexia.
- Extensive cancer metastases of liver, peritoneal metastasis,para-aortic lymph node
- Patients participating in any other clinical trails currently，or participated in other trails within 1 months.
- Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases.
- Poor treatment compliance of patients
- The group of chemotherapy alone accepts gastrectomy for bleeding or obstruction
- Failure of R0 or R1 metastasectomy and gastrectomy with D2 lymphadenectomy
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Aktiv komparator: Chemotherapy
chemotherapy with capecitabine and oxaliplatin (eight 3-week cycles of oral capecitabine 1000 mg/m² twice daily on days 1-14 plus intravenous oxaliplatin 130 mg/m² on day 1) for 6 months or progress of disease
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capecitabine and oxaliplatin (eight 3-week cycles of oral capecitabine 1000 mg/m² twice daily on days 1-14 plus intravenous oxaliplatin 130 mg/m² on day 1) for 6 months or progress of disease
Andra namn:
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Experimentell: Surgery+Chemotherapy
D2 Gastrectomy and Metastasectomy + chemotherapy with capecitabine and oxaliplatin (eight 3-week cycles of oral capecitabine 1000 mg/m² twice daily on days 1-14 plus intravenous oxaliplatin 130 mg/m² on day 1) for 6 months or progress of disease
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capecitabine and oxaliplatin (eight 3-week cycles of oral capecitabine 1000 mg/m² twice daily on days 1-14 plus intravenous oxaliplatin 130 mg/m² on day 1) for 6 months or progress of disease
Andra namn:
D2 gastrectomy + metastasectomy
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Overall survival
Tidsram: 5-year
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OS
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5-year
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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progression free survival
Tidsram: 3-year
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PFS
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3-year
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Dazhi Xu, PHD, Sun Yat-sen University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- GCGC004
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