A Randomized Phase II Trial of Neoadjuvant Chemotherapy Compared With Chemoradiotherapy in Gastric Adenocarcinoma

PHASE2CompletedINTERVENTIONAL
Enrollment

71

Participants

Timeline

Start Date

January 31, 2014

Primary Completion Date

December 31, 2016

Study Completion Date

December 31, 2017

Conditions
Stomach NeoplasmsNeoadjuvant TherapyChemoradiotherapyChemotherapy
Interventions
RADIATION

SIB-IMRT

45.1Gy and 40.04Gy in 22 fractions using intensity-modulated radiotherapy with a simultaneous integrated boost (SIB-IMRT) to primary tumor

DRUG

S-1

40mg/m2, orally twice daily every weekday concurrently with radiotherapy treatment

PROCEDURE

Surgery

Surgery, preferred D2 lymphadenectomy

DRUG

SOX

SOX (S-1: 40\~60mg, orally twice daily on days 1 to 14, oxaliplatin 130mg/m2 intravenously on day 1, 21 days per cycle)

Trial Locations (1)

100021

Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC), Beijing

All Listed Sponsors
lead

Chinese Academy of Medical Sciences

OTHER

NCT02301481 - A Randomized Phase II Trial of Neoadjuvant Chemotherapy Compared With Chemoradiotherapy in Gastric Adenocarcinoma | Biotech Hunter | Biotech Hunter