Clinical trial NCT02296658: A Phase II Study of Postoperative S-1-Based Chemoradiotherapy in Gastric Cancer
Official title: A Phase II Trial of Intensity-Modulated Radiotherapy Combined With S-1 Based Chemotherapy in Completely Resected Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stomach Neoplasms
Chemoradiotherapy, Adjuvant
Radiotherapy, Intensity-Modulated
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2014-11-20
Enrollment: 60
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: The aim of this phase II trial was to evaluate the feasibility, efficacy and tolerability of intensity-modulated radiotherapy combined with S-1 based chemotherapy in patients with pathologically positive lymph node after completely resected gastric cancer. Furthermore, the investigators sought to compare the dosimetric differences between the volumetric-modulated arc therapy (VMAT), Tomotherapy and intensity-modulated radiotherapy (IMRT) techniques in treatment planning for gastric cancer as adjuvant radiotherapy.


Eligibility criteria: Inclusion Criteria:

* Pathologically proven positive lymph node gastric adenocarcinoma in patients undergoing R0 resection
* Any prior chemotherapy is allowed in this protocol
* 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:

* 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
* 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

Primary outcomes:
measure: Disease free survival
timeFrame: 3 years
measure: Locoregional recurrence free survival
timeFrame: 3 years
measure: Overall survival
timeFrame: 3 years
measure: Distant metastasis free survival
timeFrame: 3 years
Secondary outcomes:
measure: Chemoradiotherapy-induced toxicities assessed by CTCAE 4.0
timeFrame: during treatment and within the first 30 days after completion of chemoradiotherapy
Other outcomes:
measure: Comparison of dosimetric differences between radiation techniques
timeFrame: 1 year
Locations:
city: Beijing
country: China
facility: Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
Study officials:
References: