Single high dose intraoperative electrons for advanced stage pancreatic cancer: Phase I pilot study

doi:10.1016/0360-3016(81)90002-X

International Journal of Radiation OncologyBiologyPhysics

Volume 7, Issue 7, July 1981, Pages 869-874

https://doi.org/10.1016/0360-3016(81)90002-X Get rights and content

Abstract

Phase I toxicity studies with intraoperative radiotherapy proved to be a feasible adjunct to surgery for unresectable malignancies of the pancreas at Howard University Hospital. There have been minimal side effects or complications related to the combination of limited surgical decompression and intraoperative radiotherapy alone. The procedure has now become a standard operation for the surgical radiotherapeutic team as well as the other support members, including anesthesiology, nursing and housekeeping. The toxic effects of intraoperative radiotherapy on normal tissues is being assessed on a dose volume basis. Doses of 2000–2500 rad in a single exposure to include the pancreas, regional nodes and duodenum are acceptable if the total treatment volume is less than or equal to 100 cm³ The tumoricidal effects on the cancer are demonstratable when one reviews the pathological specimens that illustrate massive tumor necrosis and fibros replacement, but in all cases reviewed, viable cancer was noted. Intraoperative radiotherapy, therefore, represents a significant “boost” dose for resectable, partially resectable or non-resectable tumors when added to conventional external beam irradiation and/or chemotherapy. Preliminary clinical data and minimal toxicity justifies further investigation.

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Intraoperative radiation therapy (IORT) is a treatment modality whereby a large single dose of radiation is delivered to a surgically open, exposed cancer site. Typically, a beam of megavoltage electrons is directed at an exposed tumor or tumor bed through a specially designed applicator system. In the last few years, IORT facilities have proliferated around the world. The IORT technique and the applicator systems used at these facilities vary greatly in sophistication and design philosophy. The IORT beam characteristics vary for different designs of applicator systems. It is necessary to document the existing techniques of IORT, to detail the dosimetry data required for accurate delivery of the prescribed dose, and to have a uniform method of dose specification for cooperative clinical trials. The specific charge to the task group includes the following: (a) identify the multidisciplinary IORT team, (b) outline special considerations that must be addressed by an IORT program, (c) review currently available IORT techniques, (d) describe dosimetric measurements necessary for accurate delivery of prescribed dose, (e) describe dosimetric measurements necessary in documenting doses to the surrounding normal tissues, (f) recommend quality assurance procedures for IORT, (g) review methods of treatment documentation and verification, and (h) recommend methods of dose specification and recording for cooperative clinical trials.
Intraoperative radiotherapy for pancreatic cancer - Requiem or revival?
1991, International Journal of Radiation Oncology, Biology, Physics
Intraoperative radiation therapy of pancreatic carcinoma: A report of RTOG-8505
1991, International Journal of Radiation Oncology, Biology, Physics
The Radiation Therapy Oncology Group in 1985 began a study of IORT plus external beam radiation therapy for patients with locally unresected, non-metastatic pancreatic cancer. Patients were treated with a combination of 2000 cGy of IORT and postoperative external beam radiation therapy to 5040 cGy in combination with IV 5-FU (500 mg/m²/day on the first 3 days of the external beam treatment). As patients were registered on study prior to exploration, it was expected that a number of patients would be excluded from further analysis at the time of surgery. Eighty-six patients were entered on study through 6/1/88 and analyzed through $490$ . Fifty-one patients were fully analyzable. Median survival time of the 51 patients was 9 months with an 18-month actuarial survival rate of 9%. Local control could not be adequately evaluated in this multi-institutional study. Major postoperative complications were not excessive and occurred in 12% of patients. Two patients had major late morbidity leading to death, one from duodenal bleeding and the second from biliary obstruction. Although this study does demonstrate the feasibility of IORT in a multi-institutional setting, it does not demonstrate any advantage of IORT over conventional therapy for this disease.
High dose, external beam and intraoperative radiotherapy in the treatment of resectable and unresectable pancreatic cancer
1990, International Journal of Radiation Oncology, Biology, Physics
Ninety patients with pancreatic cancer were treated by external beam radiotherapy (EBRT) and/or intraoperative radiotherapy (IORT) with or without surgical resection of the tumor, and the results were compared with those of a historical control comprising 112 patients treated by surgery alone. At an early stage of this study, postoperative EBRT (50–60 Gy) or IORT (25–33 Gy) was given alone, but recently the two modalities have been combined. The combination of high doses of EBRT and IORT was well tolerated provided that the gastrointestinal tract was not irradiated during IORT. Although EBRT plus IORT appeared to yield better results than either EBRT or IORT alone, the difference was not significant on multivariate analysis, and patients receiving EBRT, IORT, or EBRT + IORT were grouped together. Patients receiving radiotherapy in addition to macroscopically curative surgery had a slightly longer median survival time (14 months) than those receiving curative surgery alone (10 months), but the 3-year survival rate was similar (21% vs. 19%). In patients who underwent noncurative resection, the median survival time was significantly longer for the irradiated group (12 months) than for the control group (6.5 months). Also, in patients with unresectable lesions but no distant metastases, irradiation prolonged the median survival time significantly (8 vs. 3.5 months). In this group, there was one 5-year survivor, who received EBRT of 55 Gy plus IORT of 30 Gy to his unresectable pancreatic body lesion. Patients with metastases were also treated for palliation of symptoms, but it was found that irradiation prolonged the median survival time even in such cases (4.5 vs. 2.5 months). Based on these results, we plan to use EBRT plus IORT in all pancreatic cancer patients with no metastases.
The prevalence and severity of late effects in normal rat duodenum following intraoperative irradiation
1990, International Journal of Radiation Oncology, Biology, Physics
In humans, a portion of the duodenum is often at risk for radiation-induced complications following intraoperative radiation therapy for pancreatic carcinoma. To determine experimentally the prevalence and severity of late effects in the normal mammalian duodenum, 190 rats received single doses of 0, 15, 20, 25, 30, or 40 Gy orthovoltage X rays to temporarily exteriorized 3 cm circumferential segments of duodenum. The animals were killed 2, 6, 8, or 10 months later. Actuarial survival, change in body weight, and a radiation injury score based on eight histopathologic alterations were used as endpoints. Epithelial atypia, intestinal wall fibrosis, serosal thickening, and vascular sclerosis were the dominant histopathologic alterations at all dose levels throughout the 10-month observation period. The prevalence and severity of histologic radiation injury showed sigmoidal dose-response relationships with the plateaus starting at 20 Gy. Doses of 20 Gy or greater also resulted in a substantial loss of body weight and a high level of early deaths (20–80 days). All endpoints indicate that intraoperative doses of 20 Gy or greater are associated with unacceptable risks of late and irreversible complications.

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International Journal of Radiation OncologyBiologyPhysics

Abstract

References (15)

Contact roentgen radiation of bladder tumors

J. Urol.

Intraoperative irradiation in abdominal and cerebral tumors

Acta Radiologica

Techniques, indications, and results of intraoperative radiotherapy of advanced cancers

Radiology

Clinical experiences with intraoperative radiotherapy of locally advanced cancers

Cancer

Intraoperative radiotherapy of gastric cancer

Cancer

American Joint Committee for Cancer Staging and End Results Reporting (AJCS): Manual for Staging of Cancer

Erhahrungen and Ergebnisse mit der Nahbestrahlung operative freigelegter Tumoren

Strahlenther.

Cited by (54)

Intraoperative radiation therapy: Cut bait or keep on fishing?

Intraoperative electron beam radiation therapy: Technique, dosimetry, and dose specification: Report of task force 48 of the radiation therapy committee, American Association of Physicists in Medicine

Intraoperative radiotherapy for pancreatic cancer - Requiem or revival?

Intraoperative radiation therapy of pancreatic carcinoma: A report of RTOG-8505

High dose, external beam and intraoperative radiotherapy in the treatment of resectable and unresectable pancreatic cancer

The prevalence and severity of late effects in normal rat duodenum following intraoperative irradiation

Original contributionSingle high dose intraoperative electrons for advanced stage pancreatic cancer: Phase I pilot study

Abstract

J. Urol.

Intraoperative irradiation in abdominal and cerebral tumors

Acta Radiologica

Techniques, indications, and results of intraoperative radiotherapy of advanced cancers

Radiology

Clinical experiences with intraoperative radiotherapy of locally advanced cancers

Cancer

Intraoperative radiotherapy of gastric cancer

Cancer

American Joint Committee for Cancer Staging and End Results Reporting (AJCS): Manual for Staging of Cancer

Erhahrungen and Ergebnisse mit der Nahbestrahlung operative freigelegter Tumoren

Strahlenther.

Original contribution
Single high dose intraoperative electrons for advanced stage pancreatic cancer: Phase I pilot study