Treatment Rationale and Study Design for Clinical Trial on the Efficacy of UFT/LV for Stage II Colorectal Cancer With Risk Factors for Recurrence (JFMC46-1201).

Background: The usefulness of adjuvant chemotherapy for stage II colon cancer has not been established. Meanwhile, the presence of stage II colon cancer with high-risk factors for recurrence has been reported. To our knowledge, no prospective study of adjuvant chemotherapy for stage II colon cancer with high-risk factors has been implemented to date.

Safety analysis of two different regimens of uracil-tegafur plus leucovorin as adjuvant chemotherapy for high-risk stage II and III colon cancer in a phase III trial comparing 6 with 18 months of treatment: JFMC33-0502 trial.

Purpose: The JFMC33-0502 trial is a phase III clinical study designed to determine the most appropriate duration of postoperative adjuvant chemotherapy with uracil-tegafur (UFT) plus leucovorin in patients with stage IIB or III colon cancer. We report the interim results of preplanned safety analyses.

Methods: Patients with stage IIB or III colon cancer who had undergone curative resection were randomly assigned to receive UFT (300 mg/m(2)) plus leucovorin (75 mg/day) for 6 months (control group, 4 weeks of treatment followed by a 1-week rest, five courses) or for 18 months (study group, 5 days of treatment followed by a 2-day rest, 15 courses).

Number of lymph nodes retrieved is an important determinant of survival of patients with stage II and stage III colorectal cancer.

Objective: The number of lymph nodes retrieved is recognized to be a prognostic factor of Stage II colorectal cancer. However, the prognostic significance of the number of lymph nodes retrieved in Stage III colorectal cancer remains controversial.

Methods: The relationship between the number of lymph nodes retrieved and clinical and pathological factors, and significance of the number of lymph nodes retrieved for prognosis of Stage II and III colorectal cancer were investigated.

Final results of randomized trials by the National Surgical Adjuvant Study of Colorectal Cancer (NSAS-CC).

Objective: In the latter 1990s, adjuvant chemotherapy for completely resected Stage III colorectal cancer remained controversial in Japan. We conducted two independent randomized controlled trials in patients with Stage III colon and rectal cancer.

Methods: Patients were randomly assigned to receive surgery alone or surgery followed by treatment with UFT (400 mg/m²/day), given for five consecutive days per week for 1 year.

Randomized trial of the efficacy of adjuvant chemotherapy for colon cancer with combination therapy incorporating the oral pyrimidine 1-hexylcarbamoyl-5-fluorouracil.

Background And Aims: The purpose of the present trial was to clarify the efficacy of postoperative adjuvant chemotherapy including an oral fluoropyrimidine anticancer drug, the 1-hexylcarbamoyl-5-fluorouracil (HCFU), for the treatment of colon cancer.

Method: Patients with clinical stage Dukes' B and C colon cancer, who had been treated surgically, were assigned to a chemotherapy group treated with mitomycin C, 5-fluorouracil (5-FU), and HCFU and to a control group that received no postoperative adjuvant chemotherapy.

Results: Of the 1,001 patients registered for the study, 17 (1.

Adjuvant chemotherapy with uracil-tegafur for pathological stage III rectal cancer after mesorectal excision with selective lateral pelvic lymphadenectomy: a multicenter randomized controlled trial.

Background: Although adjuvant radiotherapy was proved to be effective for local control of rectal cancer even after standardized mesorectal excision, the role of adjuvant chemotherapy after such standardized surgery remains to be clarified. We aimed to assess the efficacy of a combination of uracil and tegafur for pathological stage III rectal cancer treated by standardized mesorectal excision with selective lateral pelvic lymphadenectomy.

Methods: We randomly assigned patients with completely resected stage III rectal cancer, who underwent standardized mesorectal excision with selective lateral pelvic lymphadenectomy, to receive either oral uracil-tegafur (400 mg/m2 tegafur per day) for one year or no treatment.

Significance of histologic type of primary lesion and metastatic lymph nodes as a prognostic factor in stage III colon cancer.

Purpose: This study was designed to investigate whether the histologic types of the primary lesion and of metastatic lymph nodes in Stage III colon cancer are useful as prognostic factors. The usefulness of adjuvant chemotherapy in a randomized, controlled trial by using these prognostic factors as stratification criteria was also investigated.

Methods: Stage III colon cancer patients were enrolled and were divided into two groups: Group W, in which the histologic type of both primary tumors and metastatic lymph nodes was well-differentiated adenocarcinoma; and Group U, in which the primary tumors and the metastatic lymph nodes were of any type other than well-differentiated.

An individual patient data meta-analysis of adjuvant therapy with carmofur in patients with curatively resected colon cancer.

Background: Oral carmofur, either as a single or in combination with other chemotherapeutic agents, has been used as adjuvant chemotherapy for curatively resected colon cancer patients. Past trials and meta-analyses indicate that it is somewhat effective in extending survival of patients with this cancer. The objective of this study was to perform a reappraisal of randomized clinical trials conducted in this regard.

A multicenter randomized study comparing 5-fluorouracil continuous infusion (ci) plus 1-hexylcarbamoyl-5-fluorouracil and 5-FU ci alone in colorectal cancer.

To verify the effectiveness of oral 1-hexylcarbamoyl-5-fluorouracil (HCFU) in improving the surgical cure rate in advanced colorectal cancer, a multicenter randomized comparative study was conducted. A total of 429 patients who had had curative resection for stage II and III colorectal cancer were randomly assigned to a study group receiving a 14-day course of 5-FU continuous infusion (320 mg/m2/day) followed by oral HCFU for a year (300 mg/day), or to the control group receiving a 14-day course of 5-FU continuous infusion alone. In terms of background factors, no significant differences were found between the 214 patients in the study group and the 215 in the control group.

Esophageal intramural spreading from an adenocarcinoma of the esophagogastric junction.

Although intramural spreading from gastric carcinoma to the esophageal wall is occasionally reported, longitudinal intramural lesion of the esophagus is very rare. We herein report the case of a patient found to have a carcinoma of the gastric cardia with intramural spreading to the esophagus approximately 7.0 cm in length.

Effective treatment with chemotherapy and surgery for advanced small cell carcinoma of the esophagus.

A 78-year-old man reported a persistent midthoracic pain, mild dysphagia, and an abdominal distention. An abdominal computed tomography scan showed massive ascites, extensive paracardial mass, a large mass which invaded the pancreas, and a mass of multiple para-aortic lymphadenopathies which involved the superior mesenteric artery. An upper gastrointestinal endoscopic study revealed an infiltrative, ulcerating tumor of the lower esophagus.

Dynamic graciloplasty resulting fecal continence without electrical stimulation: report of a case.

A 32 year-old man received dynamic graciloplasty for fecal incontinence due to a pelvic fracture. The perception of stool was obtained soon after the colostomy closure. Defecography and a manometric study showed that the patient could contract the transposed gracilis muscle independently.

Randomized controlled trial of the efficacy of adjuvant immunochemotherapy and adjuvant chemotherapy for colorectal cancer, using different combinations of the intracutaneous streptococcal preparation OK-432 and the oral pyrimidines 1-hexylcarbamoyl-5-fluorouracil and uracil/tegafur.

Background: We investigated the efficacy and safety of adjuvant immunochemotherapy and adjuvant chemotherapy for colorectal cancer, using different combinations of the intracutaneous streptococcal preparation OK-432 and the oral pyrimidines 1-hexylcarbamoyl-5-fluorouracil (carmofur, HCFU) and uracil/tegafur (UFT).

Methods: Patients with stage II, III, or IV (Dukes' B, C) colorectal cancer were enrolled and randomly assigned to one of three groups: an immunochemotherapy group (mitomycin C [MMC] + 5-fluorouracil [5-FU] + HCFU + OK-432), a chemotherapy group (MMC + 5-FU + HCFU), and a control group (surgery alone) for those with colon cancer (study 1); and an immunochemotherapy group (MMC + 5-FU + UFT + OK-432), a chemotherapy group (MMC + 5-FU + UFT), and a control group (surgery alone) for those with rectal cancer (study 2).

Results: A total of 760 patients with colon cancer and 669 patients with rectal cancer were entered into this randomized clinical trial (RCT).

Changes in colorectal cancer during a 20-year period: an extended report from the multi-institutional registry of large bowel cancer, Japan.

Purpose: This study was designed to examine trends of colorectal cancer in relation to age, gender, site, and survival during the past 20 years.

Methods: The multi-institutional registry of the Japanese Society for Cancer of the Colon and Rectum offered 87,695 surgical cases with invasive adenocarcinoma during 1978 to 1997 for analysis. We calculated survival rates and used the Cox's proportional hazard model for cases during 1978 to 1994.

The usefulness of CEA and/or CA19-9 in monitoring for recurrence in gastric cancer patients: a prospective clinical study.

Background: Many studies on postoperative carcinoembryonic antigen (CEA) and/or carbohydrate antigen (CA)19-9 monitoring after operation for gastric cancer have been reported, but most have been retrospective.

Methods: A nationwide observational study was implemented in 135 leading institutions in Japan to evaluate the significance of CEA and/or CA19-9 in postoperative monitoring for recurrence in patients with advanced gastric cancer. Three hundred and twenty-one patients examined in this analysis underwent radical gastrectomy at one of Japan's leading institutions between November 1993 and March 1996 and had been followed up for at least 5 years.

Reliable cervical anastomosis through the retrosternal route with stepwise gastric tube.

Objectives: An extra-anatomic reconstruction would be beneficial in preventing recurrent malignant dysphagia. A long gastric tube that allowed a sufficient blood flow was necessary to perform the successful cervical anastomosis through the retrosternal route.

Methods: The gastric tube was created by means of separate division and closure of the seromuscular and submucosal-mucosal layers (stepwise group) in 15 consecutive patients and by means of full-thickness cutting of the stomach and closure of the seromuscular layer (standard group) in 22 patients.

A randomized controlled trial of postoperative adjuvant immunochemotherapy for colorectal cancer with oral medicines.

Postoperative adjuvant chemotherapy reportedly improves advanced colorectal cancer patients' survival, however, it is necessary to assess what regimens are useful. Doxifluridine (5'-DFUR) is an intermediate of capecitabine approved in Europe and USA to treat metastatic colorectal cancer. 5'-DFUR is metabolized to 5-fluorouracil (5-FU) by thymidine phosphorylase existing in tumor at high concentrations, suggesting high 5-FU levels in tumor tissues and lesser complications.

Conformal radiation therapy for liver metastasis of esophageal carcinoma.

Recently, aggressive hepatectomies or hepatic arterial infusion chemotherapy for liver metastasis from gastric or colorectal carcinoma have been performed, and the number of successful studies of liver metastasis have increased. However, there have been few successful cases of liver metastasis from esophageal carcinoma by surgery or chemotherapy. Herein, we show the benefits of radiation therapy for the treatment of liver metastasis from esophageal carcinoma.

[Neo-adjuvant chemotherapy with carmofur for colorectal cancer--a multi-institutional randomized controlled study].

The efficacy and safety of preoperative chemotherapy with carmofur (HCFU) for colorectal cancer were evaluated in a randomized controlled study involving 63 institutes in the Kanto area. Patients aged 75 or younger with Dukes' B or C colorectal cancer were eligible if curative surgery was expected. In the end, 326 were eligible from 405 consecutive colorectal cancer patients.

Feasibility of dividing the main vessels for enhancement of dynamic graciloplasty.

Purpose: The technique of dynamic graciloplasty is not yet-completely satisfactory. Its function could be improved by ensuring total wrapping of the neoanus with the muscular part of the gracilis, but this can only be achieved by dividing the main blood vessels, which are considered essential for blood supply to the flap. We devised a vascular delay technique to preserve the flap without these vessels, which we performed first experimentally, then clinically, with promising results.

Thoracoscopic esophagectomy combined with mediastinoscopy via the neck.

Although thoracoscopic techniques have been introduced to esophageal surgery, the identification of the left recurrent laryngeal nerve and lymph node dissection along the nerve remain quite difficult. A mediastinoscopic technique via the neck enables an excellent visual field to be created in the upper mediastinum, especially near the left recurrent laryngeal nerve. Therefore, a thoracoscopic esophagectomy combined with this technique allows mediastinal lymph nodes along the left recurrent laryngeal nerve to be easily and safely dissected.