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

NCT02301481 | Completed Phase 2 DMC

• 1 other identifier: NCC2015ST-09
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, randomized phase II study is designed to evaluate weather neoadjuvant chemoradiotherapy is superior to neoadjuvant chemotherapy with both followed by surgery and postoperative chemotherapy for locally advanced gastric adenocarcinoma.

Conditions

Stomach Neoplasms; Neoadjuvant Therapy; Chemoradiotherapy; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• R0 resection rate

  The surgical procedure was total or subtotal gastrectomy with recommended D2 lymphadenectomy 4-6 weeks after neoadjuvant therapy.

  2-3 months

Secondary Outcomes (7)

• Pathological response rate

  2-3 months

• Tumor down-staging

  2-3 months

• Postoperative complications

  2-3 months

• Acute chemotherapy/Chemoradiotherapy toxicities

  6-8 months

• Distant metastasis free survival

  3 years

Other Outcomes (1)

• Comparison of dosimetric differences between radiation techniques

  1 year

Study Arms (2)

Neoadjuvant Chemoradiotherapy (NCRT)

EXPERIMENTAL

NCRT arm receives intensity-modulated radiotherapy with a simultaneous integrated boost (SIB-IMRT) (45.1Gy and 40.04Gy in 22 fractions) concurrently with oral S-1(40mg/m2, orally twice daily every weekday) followed by surgery and four to six cycles of SOX at the same dosage with NCT arm.

Radiation: SIB-IMRT; Drug: S-1; Procedure: Surgery; Drug: SOX

Neoadjuvant Chemotherapy (NCT)

ACTIVE COMPARATOR

NCT arm consists of neoadjuvant three cycles of SOX(S-1: 40\~60mg, orally twice daily on days 1 to 14, oxaliplatin 130mg/m2 intravenously on day 1, 21 days per cycle followed by radical surgery and another postoperative three cycles of SOX.

Procedure: Surgery; Drug: SOX

Interventions

SIB-IMRT RADIATION

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

Neoadjuvant Chemoradiotherapy (NCRT)

S-1 DRUG

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

Also known as: TS-1

Neoadjuvant Chemoradiotherapy (NCRT)

Surgery PROCEDURE

Surgery, preferred D2 lymphadenectomy

Neoadjuvant Chemoradiotherapy (NCRT); Neoadjuvant Chemotherapy (NCT)

SOX DRUG

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

Also known as: TS-1; Oxaliplatin for injection

Neoadjuvant Chemoradiotherapy (NCRT); Neoadjuvant Chemotherapy (NCT)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically proven locally advanced gastric adenocarcinoma in patients staged as cT3-4N0M0 or anyTN+M0
• No distant metastasis in liver,lung,bone,central nervous system(CNS),no peritoneal transplantation
• No prior abdominal or pelvic radiotherapy
• Karnofsky performance status(KPS)≥ 70, predictive life span no less than 6 months
• Patients must have normal organ and marrow function as defined below: Leukocytes: greater than or equal to 3,000 G/L; Platelets: greater than or equal to 100,000/mm3 .Hemoglobin:greater than or equal to 10g/L .Total bilirubin: within normal institutional limits; AST/ALT: less than or equal to 1.5 times the upper limit; Creatinine within normal upper limits
• Informed consent

You may not qualify if:

• Any prior chemotherapy or other cancer treatment prior to this protocol
• Patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer
• With any distant metastasis in liver,lung,bone,CNS,or peritoneal transplantation
• History of allergic reactions attributed to similar chemical or biologic complex to S-1 or Xeloda or Oxaliplatin
• Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness
• History of myocardial infarction within the past 6 months or history of ventricular arrhythmia
• History of prior radiation to the abdomen
• Pregnant or lactating females

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

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

Beijing, 100021, China

Location

Related Publications (1)

• Wang X, Zhao DB, Yang L, Chi Y, Zhao H, Jiang LM, Jiang J, Tang Y, Li N, Liu WY, Dou LZ, Zou SM, Xue LY, Ren JS, Tian YT, Che X, Guo CG, Bai XF, Sun YM, Wang SL, Song YW, Liu YP, Fang H, Li YX, Jin J. Preoperative Concurrent Chemoradiotherapy Versus Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer: Phase II Randomized Study. Front Oncol. 2022 Apr 29;12:870741. doi: 10.3389/fonc.2022.870741. eCollection 2022.

  PMID: 35574368 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

S 1 (combination); titanium silicide; Surgical Procedures, Operative; Oxaliplatin; Injections

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 23, 2014
• First Posted: November 26, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: October 16, 2019

Record last verified: 2019-10

Locations

CN (1)