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

Stomach Neoplasms Clinical Trial

Official title:

A Prospective, Randomized Phase II Trial of Neoadjuvant Chemotherapy Compared With Concomitant Boost Intensity-Modulated Radiotherapy With S-1 in Locally Advanced Gastric Adenocarcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02301481
• Other study ID #: NCC2015ST-09
• Status: Completed
• Phase: Phase 2
• Start date: January 2014
• Est. completion date: December 2017

Study information

• Verified date: October 2019
• Source: Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Adenocarcinoma
• Chemoradiotherapy
• Chemotherapy
• Neoadjuvant Therapy
• Stomach Neoplasms

Intervention

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)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comparison of dosimetric differences between radiation techniques	To compare the dosimetric differences between the volumetric-modulated arc therapy (VMAT), Tomotherapy and intensity-modulated radiotherapy (IMRT) techniques in treatment planning.	1 year
Primary	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	Pathological response rate	Pathological response were classi?ed into three grades.Grade I signi?es that there is little shrinkage in the tumor; only mild regression in the tumor cells is observed under themicroscope. Grade II shows gross reduction in size of the tumor and marked regression in the cancer cells microscopically, yet viable nests of cancer tissue are still visible. Grade III implies complete or almost total resolution of the tumor on exploration, and disappearance of the tumor tissue microscopically; only remnants of degenerated cancer cells can be seen (so-called ghost cancer cells).	2-3 months
Secondary	Tumor down-staging	Down-staging was considered as any stage reduction between clinical and pathologic stage.	2-3 months
Secondary	Postoperative complications	During hospital stay and within the first 30 days after completion of surgery.	2-3 months
Secondary	Acute chemotherapy/Chemoradiotherapy toxicities	chemotherapy toxicities are evaluated by NCI-CTC version 4.0 and radiotherapy toxicities are graded using the RTOG/EORTC Radiation Morbidity Scoring Schema.	6-8 months
Secondary	Distant metastasis free survival		3 years
Secondary	Locoregional recurrence free survival		3 years
Secondary	Overall survival		3 years