Study of Hypo-fractionated Neoadjuvant Radiotherapy for Locally Advanced Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

Phase I Study of Hypo-fractionated Neoadjuvant Radiotherapy for Locally Advanced Gastric Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03427684
• Other study ID #: CAMS-GIRO-G005
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: January 28, 2018
• Last updated: February 8, 2018
• Start date: May 1, 2016
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2018
• Source: Chinese Academy of Medical Sciences
• Contact: Jing Jin, MD
• Phone: 8610-87787658
• Email: jinjing1025[@]csco.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Gastric cancer is one of the most common malignant tumors in China, and the incidence and mortality rate are second in malignant tumors. The treatment of gastric cancer need integrated multidisciplinary treatment, and surgery is the only possible curative method for gastric cancer at present. Previous studies have reported that neoadjuvant chemoradiotherapy can downstage primary tumor to increase radical resection rate in order to improve the long-term prognosis of advanced gastric cancer. However, there is no study on the application of hypo-radiotherapy to neoadjuvant radiotherapy in gastric cancer. The aim of this study was to observe the maximum tolerated dose (MTD) and dose limited toxicity (DLT) of hypo-fractionated radiotherapy for locally advanced gastric cancer.

Description:

After enrolled in this study, the patient was first treated with radiotherapy, concurrent with oral S-1 80mg/m2/day, on radiotherapy days. 3 weeks after the end of radiotherapy, patients treated with neoadjuvant chemotherapy with oxaliplatin and S-1. Oxaliplatin is given on dose of 130mg/m2 iv on day 1; S-1 on 40-60mg po BID on day 1-14, oral. Imaging evaluation was performed 3 weeks after neoadjuvant treatment. The radical operation and surgical procedure were determined on MDT discussion. Non-operable patients continue with 3 cycles of chemotherapy, and the chemotherapy regimen can be changed. A 3 cycle of SOX adjuvant chemotherapy was performed after surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Clinical stage T3-4N+M0

• Gastric cancer or Siewert II/III esophagogastric junction carcinoma;

• Pathologically confirmed adenocarcinoma;

• 18-75 years old, male or female;

• Karnofsky score >= 70;

• White blood cell count >= 4 x 109 / L; platelet count >= 100 x109/L; serum creatinine =< 1 x upper limit of normal, total bilirubin =< 1 x upper limit of normal, alanine aminotransferase and aspartate aminotransferase =< 2.5 x upper limit of normal, alkaline phosphatase =< 5 x upper limit of normal.

Exclusion Criteria:

• Any chemotherapy or radiotherapy history before enrollment

• Siewert I EGJ cancer

Related Conditions & MeSH terms

• Chemoradiation
• Gastric Cancer
• Stomach Neoplasms

Intervention

Radiation:
• Hypo-fractionated radiotherapy
Hypo-fractionated radiotherapy with fraction >2Gy .

Drug:
• S1
S-1 80mg/m2/day, orally intake on radiotherapy days.

Locations

Country	Name	City	State
China	Cancer Hospital, Chinese academy of medical sciences	Beijing	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
Primary	Maximum tolerated dose AND Dose limited toxicity	To assess maximum tolerated dose and dose limited toxicity of hypo-fractionated neoadjuvant radiotherapy	From date of enrollment until one month after chemo-radiotherapy
Secondary	Response rate	To evaluate the pathological response rate of gastric cancer after hypo-fractionated neoadjuvant radiotherapy	From date of enrollment until surgery, assessed up to 2 months
Secondary	2-year disease-free survival	To evaluate the 2-year disease-free survival of gastric cancer after hypo-fractionated neoadjuvant radiotherapy	From date of enrollment until the date of first documented progression or date of relapse, whichever came first, assessed up to 24 months