Fletcher G H, Lindberg R D, Caderao J B, Wharton J T
Cancer. 1977 Feb;39(2):617-23. doi: 10.1002/1097-0142(197702)39:2<617::aid-cncr2820390237>3.0.co;2-2.
From September 1968 to March 1974, a randomized clinical trial was carried out, using conventional fractionation, i.e., five treatments per week, in 233 patients with advanced cancers of the uterine cervix--Stages IIB, IIA, IIIB and IVA. The age limit was 70 years and all patients had medical clearance. Lymphangiography and, in some patients, an exploratory laparotomy with selective lymphadenectomy, were done prior to treatment to determine the extent of nodal disease. The staging has not been changed either by lymphangiogram or lymphadenectomy findings. A few patients with bulky Stage I and IIA lesions were entered into the trial because of extensive nodal disease demonstrated either by lymphangiogram and/or lymphadenectomy. First, the patients were grouped according to the clinical stage. The secondary stratification was according to the lymphangiogram and/or selective lymphadenectomy findings. The patients were then randomized to air or hyperbaric oxygen within each group. The patients were pressurized in a Vickers chamber at 3 atmosphere absolute, using a 20-minute soak time prior to the irradition. The size of the external beam portal was determined by the status of the nodes. The difference in absolute NED (no evidence of disease) survival rates for both groups as a whole and by stages is not statistically significant. There is no difference in the incidence of failures in the irradiated area between the HPO and air patients. There is no increase in distant metastases in the HP group. It does not seem that the HPO has had an effect on the major complications. However, there was an increase in the incidence of complications with extended fields. The addition of lymphadenectomy had increased the incidence of fatal complications, even with routine pelvic portals. The negative results of this trial with conventional fractioantion should not lead to the conclusion that HPO could not be useful with schemes using a few high dose fractions.
1968年9月至1974年3月，对233例IIB、IIA、IIIB和IVA期子宫颈癌晚期患者进行了一项采用常规分割（即每周五次治疗）的随机临床试验。年龄限制为70岁，所有患者均通过了医学检查。治疗前进行了淋巴管造影，部分患者还进行了探查性剖腹术及选择性淋巴结切除术，以确定淋巴结疾病的范围。淋巴管造影或淋巴结切除术的结果均未改变分期。少数I期和IIA期肿块较大的患者因淋巴管造影和/或淋巴结切除术显示有广泛的淋巴结疾病而纳入试验。首先，根据临床分期对患者进行分组。二级分层依据淋巴管造影和/或选择性淋巴结切除术的结果。然后将每组患者随机分为空气组或高压氧组。在照射前，患者在维氏舱内以3个绝对大气压加压，浸泡20分钟。外照射野的大小由淋巴结状态决定。两组总体及各分期的绝对无疾病生存（NED）率差异无统计学意义。高压氧组和空气组患者照射区域的失败发生率无差异。高压氧组远处转移率未增加。高压氧似乎对主要并发症没有影响。然而，扩大照射野时并发症发生率增加。即使采用常规盆腔照射野，增加淋巴结切除术也会增加致命并发症的发生率。这项采用常规分割的试验的阴性结果不应导致得出高压氧对采用少数高剂量分割方案无用的结论。
