The Clinical Randomized Study Of 7-day Continuous Accelerated Irradiation In Patients With Esophageal Carcinoma

Objective: Toxicity and therapeutic efficacy of 7-day continuous accelerated irradiation schedule (CAIR) was evaluated and compared with late course accelerated hyperfractionation radiotherapy schedule (LCAF) for esophageal carcinoma in a randomized trial. Methods: From February to August , 2002, 57 patients were recruited for this study. The eligibility criteria were: newly histologically confirmed squamous cell carcinoma without previous treatment, age ≤70, KPS≥70, a primary tumor length of 3-10cm, no evidence of perforation or bleeding, no supraclavicular lymph node enlargement, and no distant metastases, acceptance of informed consent. Pretreatment evaluation included taking a detailed medical history, along with a thorough physical examination, chest radiograph, chest CT, esophageal barium test, abdominal ultrasonic examination, Liver function, kidney function, and cardic function test, and complete blood test. All patients were hospitalized during the treatment because acute reactions were expected to be more severe. The patients were randomly divided into two groups: a)7-day continuous accelerated irradiation group (CAIR group), and b) late course accelerated hyperfractionation radiotherapy group (LCAF group). The patient distribution between the two groups showed no significant difference (P>0.05).The patients in LCAF group were first treated with conventional fractionated irradiation (2Gy a time daily, 5 times per week) for a total dose of 30Gy in 3 weeks and then with accelerated hyperfractionation (twice daily at 1.5Gy per fraction with a minimum interval of 6h between the two fractions, 5 days per week) for a total dose of 30Gy in two weeks. The patients in the CAIR group were treated in daily fraction of 2Gy, 7 times per week for a total dose of 60Gy in 30 days (4.3 weeks). The Six-MV X-ray accelerator was used in the present study. The irradiation dose to the spinal cord was limited to less than 40Gy in both groups.The radiation fields were designed on the basis of the chest CT, barium examination, and esophagoscopy. A 3-field strategy (one anterior and two posterior oblique fields) was applied for all patients. The range of width for the field was 5-8cm, and the length of the field covered the primary tumor with 3-5cm margins from both ends of the primary lesion.A complete blood test was taken every week during the treatment, and once at the end of treatment. A barium mealwas done at the time of 30Gy and at the end of treatment. The tumor response was assessed at the end of treatment, and acute radiation esophagitis was assessed twice a week during treatment, three months after radiotherapy, and once very month, subsequently. Acute and late toxicities were observed and graded according to the RTOG criteria (1995).Result: The incidence rates of early tumor response were similar between two groups and were 96.6% in CAIR group and 100% in LCAF group. The 1-year local tumor control was 90.79% in CAIR group and 77.14% in LCAF group, respectively, and no significant difference was observed in two groups (P=0.210). The 1-year overall survival rates were 66.14% and 64.72% in CAIR group and in LCAF group, respectively. The 1-year case-specific survival rates were 74.19% and 64.72% in CAIR and LCAF group, and the rate in CAIR group was higher than that in LCAF group, but there was no significant difference in two groups (P=0.689).The incidence rate of the acute radiation esophagitis in CAIR group was higher than that in LCAF group, and the rate was 96.4% and 89.3% respectively. The rate of GradeⅠand GradeⅡ esophagitis in two groups was similar. However, the rate of Grade Ⅲ esophagitis in CAIR group was higher than that in LCAF group and 9 patients were observed in CAIR group and 4 patients in LCAF group.One patient in CAIR group died at the end of treatment because of perforation and bleeding and he was regarded as having a Grade Ⅴ esophagitis. No patients developed Grade Ⅳ in either groups from the commencement of therapy till 90 days later. No s...