Compare S-1 Plus Oxaliplatin to S-1 as Adjuvant Chemotherapy After D2 Resection in Patients With Gastric Cancer (CAPITAL)
A Prospective,Multicentral,Open-label,Randomized,Controlled,Phase III Clinical Trial to Compare S-1 Plus Oxaliplatin to S-1 as Adjuvant Chemotherapy After D2 Resection in Patients With Gastric Cancer
Background: It is shown that TS-1 as adjuvant chemotherapy after D2 resection in patients with gastric cancer can improve DFS and OS in one Japanese Trial. And TS-1 has become one of the standard therapies to these patients. But it is still unknown whether it would improve more to OS and DFS than single TS-1 after combined with oxaliplatin . This trial is designed to investigate the efficacy and safety of TS-1 plus oxaliplatin versus TS-1 single as adjuvant chemotherapy after D2 resection in patients with gastric cancer.
Patients and methods: In this study , patients with histologically confirmed gastric cancer who received D2 resection and staged II or III, aged from 18 to 70 years and with Eastern Cooperative Oncology Group performance status ≤2 and adequate organ function, are randomized 1:1 to oxaliplatin 100mg/m2 on day 1 and TS-1 40~60mg twice everyday for 14 days in a 21-days cycle for total 6 cycles followed by TS-1 single with the same dose and frequency to the end of the 1st year postoperatively(SOX) , or TS-1 single 40~60mg twice everyday for 14 days in a 21-days cycle to the end of the 1st year postoperatively (TS-1). The primary end point is overall survival (OS), and secondary end point is disease free survival(DFS) and safety. Final study analysis will be conducted in the end of the 5th year after the last patient's enrollment.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
-
-
Guangdong
-
Chaozhou, Guangdong, Chine
- the central hospital of Chaozhou
-
Foshan, Guangdong, Chine
- The 1st People's Hospital of Foshan
-
Guangzhou, Guangdong, Chine
- Cancer center of Sun Yat-sen University
-
Guangzhou, Guangdong, Chine
- cancer center of Guangzhou medical college
-
Guangzhou, Guangdong, Chine
- Guangdong Traditional Medical Hospital
-
Guangzhou, Guangdong, Chine
- the 1st affliated hospital of Guangdong pharmacuetic college
-
Guangzhou, Guangdong, Chine
- the 1St Affliated Hospital of Guangzhou Medical College
-
Guangzhou, Guangdong, Chine
- the 6th affliated hospital of Sun-yat-sen University
-
Shantou, Guangdong, Chine
- the 1st hospital of Shantou University
-
Shantou, Guangdong, Chine
- the cental hospital of Shantou
-
Shaoguan, Guangdong, Chine
- YUE-BEI people's hospital
-
Shenzhen, Guangdong, Chine
- The 2nd People's Hospital of Shenzhen
-
Zhuhai, Guangdong, Chine
- the 5th hospital of Sun-yat-sen University
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- informed consensus of patients
- be able to receive oral administration
- from 18 to 70 years old
- be proven to be primary adenocarcinoma of gastric cancer and staged II or III by pathological evidences
- without other chemotherapy and/or radiation against to the disease
- normal function of other organs including heart,liver ,kidney and so on
- Eastern Cooperative Oncology Group performance status:0~2
Exclusion Criteria:
- history of other malignancy
- allergic reaction to S-1 or oxaliplatin
- be enrolling in other clinical trials
- abnormal GI tract function
- dysfunction of other organs
- female in pregnancy or lactation,or refuse to receive Contraception measures during chemotherapy
- other situation to be judged not adaptive to the study by investigators
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: S-1 plus Oxaliplatin
6 courses chemotherapy with S-1 plus oxaliplatin followed by 10 courses S-1 single after d D2 resection
|
6 courses chemotherapy with S-1 plus oxaliplatin followed by 10 courses S-1 single after d D2 resection
Autres noms:
|
|
Comparateur actif: S-1 single
S-1 40~60mg twice daily for 14 days in 3 weeks for totally 16 courses after D2 resection
|
16 courses S-1 single after d D2 resection
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
la survie globale
Délai: 5 ans
|
5 ans
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
survie sans maladie
Délai: 3 années
|
3 années
|
|
Nombre de participants avec événements indésirables
Délai: 5 ans
|
5 ans
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Zhiwei Zhou, PHD, SunYat-sen University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SYSUCCGPS
- ZHOUZHIWEI (Identificateur de registre: ZZHIWEI)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .