Clinical trial NCT03427684: Study of Hypo-fractionated Neoadjuvant Radiotherapy for Locally Advanced Gastric Cancer
Official title: Phase I Study of Hypo-fractionated Neoadjuvant Radiotherapy for Locally Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Gastric Cancer
Chemoradiation
Keywords: Gastric cancer
Chemo-radiotherapy
Phase I study
Hypo-fractionated radiotherapy
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2018-02-09
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximum tolerated dose AND Dose limited toxicity
timeFrame: From date of enrollment until one month after chemo-radiotherapy
Secondary outcomes:
measure: Response rate
timeFrame: From date of enrollment until surgery, assessed up to 2 months
measure: 2-year disease-free survival
timeFrame: From date of enrollment until the date of first documented progression or date of relapse, whichever came first, assessed up to 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese academy of medical sciences
state: Beijing
Study officials:
References:
citation: Li N, Xiang X, Zhao D, Wang X, Tang Y, Chi Y, Yang L, Jiang L, Jiang J, Shi J, Liu W, Fang H, Tang Y, Chen B, Lu N, Jing H, Qi S, Wang S, Liu Y, Song Y, Li Y, Zhang L, Jin J. Preoperative versus postoperative chemo-radiotherapy for locally advanced gastric cancer: a multicenter propensity score-matched analysis. BMC Cancer. 2022 Feb 26;22(1):212. doi: 10.1186/s12885-022-09297-7.
citation: Li N, Wang X, Tang Y, Zhao D, Chi Y, Yang L, Jiang L, Jiang J, Liu W, Tang Y, Fang H, Liu Y, Song Y, Wang S, Jin J, Li Y. A prospective phase I study of hypo-fractionated neoadjuvant radiotherapy for locally advanced gastric cancer. BMC Cancer. 2018 Aug 8;18(1):803. doi: 10.1186/s12885-018-4707-9.