Phase II trial
Phase-II study on stereotactic radiotherapy of locally advanced pancreatic carcinoma

https://doi.org/10.1016/j.radonc.2004.12.022Get rights and content

Abstract

Background and purpose

The majority of patients with pancreatic cancer have advanced disease at the time of diagnosis and are not amenable for surgery. Stereotactic radiotherapy (SRT) may be an alternative treatment for patients with locally advanced disease. The effect of SRT was investigated in the present phase-II trial.

Patients and methods

Twenty-two patients with locally advanced and surgically non-resectable, histological proven pancreatic carcinoma were included into the trial. The patients were immobilized by the Elekta stereotactic body frame (SBF) or a custom made body frame. SRT was given on standard LINAC with standard multi-leaf collimator. Central dose was 15 Gy×3 within 5–10 days.

Results

Evaluation of response was found to be very difficult due to radiation and tumour related tissue reaction. Only two patients (9%) were found to have a partial response (PR), the remaining had no change (NC) or progression (PD) after treatment. Six patients had local tumour progression, but only one patient had an isolated local failure without simultaneous distant metastasis. Median time to local or distant progression was 4.8 months. Median survival time was 5.7 months and only 5% were alive 1 year after treatment. Acute toxicity reported 14 days after treatment was pronounced. There was a significant deterioration of performance status (P=0.008), more nausea (P=0.001) and more pain (P=0.008) after 14 days compared with base-line. However, 8 of 12 patients (66%) improved in performance status, scored less nausea, pain, or needed less analgesic drugs at 3 months after treatment. Four patients suffered from severe mucositis or ulceration of the stomach or duodenum and one of the patients had a non-fatal ulcer perforation of the stomach.

Conclusions

SRT was associated with poor outcome, unacceptable toxicity and questionable palliative effect and cannot be recommended for patients with advanced pancreatic carcinoma.

Section snippets

Patient selection

Patients entered the study from January 2000 to July 2001 based on the following criteria: histological or cytological proven adenocarcinoma of the pancreas, inoperable judged by the surgeon, the radiologist and the oncologist, UICC stage T1-3 N0 M0 (=AJCC stages I–II)[14], no more than 6 cm in largest diameter, tumour visualized on CT-scan, WHO/ECOG performance status 0–2, and informed consent by the patient. All patients underwent CT-scan, 14 patients went through endoscopic ultrasonography

Results

A total number of 22 patients with pancreatic cancer were included in the study. Of these, 19 had an inoperable primary pancreatic cancer and three had a recurrence after a Whipple resection, two with a local recurrence and one with a lymph node metastasis. Patient characteristics are given in Table 1. All patients had non-resectable tumours due to invasion of vessels or other adjacent structures. Twelve females and 10 males were included. Median age was 61 (43–76) years. At the time of

Discussion

Extracranial stereotactic radiotherapy (ESRT) based on the SBF was introduced at Karolinska Hospital, Stockholm in the early 1990s [12]. A large number of SBF's have been distributed around Europe, North America, and Asia, and a large number of patients have undergone ESRT based on principles of the SBF or other custom made systems. Even though the number of patients treated with ESRT is high, only limited scientific evidence supports the treatment. So far, only few prospective and few

Acknowledgements

This study was supported by a grant from the Kloppenborg X-knife foundation.

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