title: A prospective, randomized trial of pre-operative and intraoperative radiotherapy versus surgery alone in resectable gastric cancer.
abstract: BACKGROUND
  Worldwide, gastric cancer remains one of the most common malignancies. Discouraging survival rates after surgical treatment promote the study of adjuvant therapy. A prospectively, randomized, controlled clinical trial was performed in order to determine whether pre-operative and intraoperative radiotherapy improves treatment results of gastrectomy for stomach carcinoma.
  
  
  METHODS
  From 1993 to 1998, 112 patients were randomized and underwent exploratory laparotomy; among them 78 satisfied protocol requirements and entered in the trial. Patients in the experimental group were treated with pre-operative radiotherapy (20 Gy/5 days), gastrectomy and intraoperative radiotherapy (20 Gy using 8-12 electrons). Patients in the control group underwent surgery alone.
  
  
  RESULTS
  Incidence and distribution of post-operative complications were similar in both groups except significantly higher incidence of pancreatitis after surgical treatment. No late radiation-related morbidity was registered. There was no significant difference in survival between the two treatment groups (Chi(2)=1.026, df=1, P=0. 311) as well as in N0 (Chi(2)=0.0029, df=1, P=0.956) and T1-2 subgroups (Chi(2)=0.1928, df=1, P=0.660). In contrast, combined treatment had marked survival advantage in more advanced stages: in the case of lymph-node involvement (Chi(2)=4.19, df=1, P=0.04) and extragastric tumour extension (Chi(2)=4.118, df=1, P=0.042).
  
  
  CONCLUSIONS
  The proposed intensive treatment programme is feasible, shows good acute and late tolerance and has the potential to improve survival in patients with locally advanced gastric cancer.
authors.affiliation: Department of Surgical and Combined Treatment of Abdominal Tumours, Medical Radiological Research Center of Russian Academy of Medical Sciences (MRRC RAMS), Koroliova Street 4, Obninsk, 249020, Russia. skoropad@mrrc.obninsk.ru
authors.forename: V Y
authors.initials: VY
authors.lastname: Skoropad
authors.forename: B A
authors.initials: BA
authors.lastname: Berdov
authors.forename: Y S
authors.initials: YS
authors.lastname: Mardynski
authors.forename: L N
authors.initials: LN
authors.lastname: Titova
mesh_terms: D000328:Adult; D000368:Aged; D003131:Combined Modality Therapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007432:Intraoperative Period; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D011300:Preoperative Care; D011446:Prospective Studies; D018714:Radiotherapy, Adjuvant / Q000009:adverse effects; D012008:Recurrence; D013274:Stomach Neoplasms / Q000401:mortality / Q000532:radiotherapy* / Q000601:surgery*; D016019:Survival Analysis