A prospective, randomized trial of pre-operative and intraoperative radiotherapy versus surgery alone in resectable gastric cancer.
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.
Skoropad
V Y
VY
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
Berdov
B A
BA
Mardynski
Y S
YS
Titova
L N
LN
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