- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03973008
Adujvant CT+CRT vs Adujvant CT After D2 Resection for Locally Advanced Proximal Gastric Adenocarcinoma
1. juni 2019 opdateret af: Zhejiang Cancer Hospital
Phase III, Randomized, Open-label Study of Adjuvant Chemotherapy Combined With Chemoradiotherapy Versus Adujvant Chemotherapy After Standard D2 Resection for Locally Advanced Proximal Gastric Adenocarcinoma
This study evaluates the addition of adjuvant chemoradiotherapy to adjuvant chemotherapy in the treatment of locally advanced proximal gastric adenocarcinoma after standard D2 radical resection.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Because of its special anatomical structure, local recurrence rate of locally advanced proximal gastric adenocarcinoma is still high after radical operation.
As a local/regional therapy, radiotherapy combined with concurrent chemotherapy can kill local residual tumor cells and reduce the risk of local and regional recurrence.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
408
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Luying Liu
- Telefonnummer: 13957113195
- E-mail: luyingliu@163.com
Undersøgelse Kontakt Backup
- Navn: Jinwen Shen
- Telefonnummer: 13616543578
- E-mail: shenjw2005@126.com
Studiesteder
-
-
Zhejiang
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Hangzhou, Zhejiang, Kina, 310022
- Rekruttering
- Jinwen Shen
-
Kontakt:
- Jinwen Shen
- E-mail: shenjw2005@126.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Voluntary Participation and Written Signature of Informed Consent.
- Age 18-70, gender unlimited.
- Gross pathology confirmed that the tumor center was within 1 cm to 5 cm of the EGJ line. Histopathologically diagnosed as adenocarcinoma.
- No neoadjuvant therapy.
- Transabdominal standard D2 radical operation was performed and R0 resection was performed. Ascites cytology was negative.
- The pathological stages were IIB, IIIA, IIIB and IIIC.
- There was no intraperitoneal implantation and distant metastasis. CT should be routinely performed to evaluate the tumor bed before radiotherapy. Positron emission tomography (PET-CT) could be accepted to determine whether there was residual or distant metastasis.
- Physical condition score ECOG 0-1.
- No history of serious heart and lung diseases, abnormal hematological examination and immunodeficiency: hemoglobin (Hb) > 9 g/dL; white blood cell (WBC) > 3 x 109/L; neutrophil (ANC) > 1.5 x 109/L; platelet (Pt) > 100 x 109/L; bilirubin < 1.5 times the upper limit of normal value; glutathione transaminase (ALT) & alanine transaminase (AST) = 2.5 times the upper limit of normal value; serum creatinine < 1.5 times the normal value Upper limit.
- No other systemic tumors were found.
- Fertile men or women are willing to take contraceptive measures in the trial.
- The daily energy intake is more than 1500 kcal.
Exclusion Criteria:
- Those who had a history of malignant tumors (except skin basal cell carcinoma, thyroid papillary adenocarcinoma and cervical carcinoma in situ, who survived for more than 3 years after treatment).
- Patients with a history of neoadjuvant radiotherapy and chemotherapy before operation.
- Study participants who participated in other clinical trials within 30 days before treatment.
- Pregnancy, lactation or fertility without contraceptive measures.
- Drug addiction and other adverse drug addiction, long-term alcoholism and AIDS patients.
- Those with uncontrollable infections, seizures, or loss of self-awareness due to mental illness.
- Those with a history of severe allergy or specific constitution.
- Researchers believe that it is not appropriate to participate in this experiment.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Adujvant CT+CRT
Four to six weeks after D2 radical surgery, adjuvant chemotherapy was initiated with SOX regimen , repeated every three weeks, and adjuvant radiotherapy was started at the end of two cycles of adjuvant chemotherapy , with synchronous tegiol single drug chemotherapy.
And the original SOX regimen was continued for 4 cycles after 3-4 weeks of radiotherapy.
|
DT 45Gy/25F/5W, using IMRT technology, synchronous tegio single drug chemotherapy
Andre navne:
Oxalis 130mg/m2 intravenous drip on day 1, tegio 80-120 mg daily, twice, half an hour after breakfast and dinner, for 14 consecutive days
Andre navne:
|
|
Aktiv komparator: Adujvant CT
The adjuvant chemotherapy was started 4-6 weeks after D2 radical operation.
The SOX regimen was repeated every 3 weeks for 8 cycles.
|
Oxalis 130mg/m2 intravenous drip on day 1, tegio 80-120 mg daily, twice, half an hour after breakfast and dinner, for 14 consecutive days
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
disease-free survival
Tidsramme: 3 year
|
after primary treatment the patient survives without any signs or symptoms of cancer.
|
3 year
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Xiangdong Cheng, Zhejiang Cancer Hospital
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
11. marts 2019
Primær færdiggørelse (Forventet)
29. februar 2024
Studieafslutning (Forventet)
31. maj 2025
Datoer for studieregistrering
Først indsendt
1. juni 2019
Først indsendt, der opfyldte QC-kriterier
1. juni 2019
Først opslået (Faktiske)
4. juni 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. juni 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. juni 2019
Sidst verificeret
1. maj 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ZJCH-GA-CRT
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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