Preoperative hyperfractionated acclerated radiotherapy (HART) and concomittant CPT-11 in advanced rectal carcinoma. A phase I study.

Voelter, V; Stupp, R; Matter, M; Gillet, M; Bouzourene, H; Leyvraz, S; COUCKE, Philippe

doi:10.1016/S0360-3016(03)00326-2

Article (Scientific journals)

Preoperative hyperfractionated acclerated radiotherapy (HART) and concomittant CPT-11 in advanced rectal carcinoma. A phase I study.

Voelter, V; Stupp, R; Matter, M et al.

2003 • In International Journal of Radiation, Oncology, Biology, Physics, 56 (5), p. 1288-1294

Peer Reviewed verified by ORBi

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https://hdl.handle.net/2268/16974

DOI
10.1016/S0360-3016(03)00326-2

PubMed
12873673

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Keywords :

Preoperative radiochemotherapy; CPT-11; Hyperfractionated radiotherapy; Rectal cancer

Abstract :

[en] Purpose: Patients with locally advanced rectal carcinoma are at risk for both local recurrence and distant metastases. We demonstrated the efficacy of preoperative hyperfractionated accelerated radiotherapy (HART). In this Phase I trial, we aimed at introducing chemotherapy early in the treatment course with both intrinsic antitumor activity and a radiosensitizer effect. Methods and Materials: Twenty-eight patients (19 males; median age 63, range 28–75) with advanced rectal carcinoma (cT3: 24; cT4: 4; cN : 12; M1: 5) were enrolled, including 8 patients treated at the maximally tolerated dose. Escalating doses of CPT-11 (30–105 mg/m2/week) were given on Days 1, 8, and 15, and concomitant HART (41.6 Gy, 1.6 Gy bid 13 days) started on Day 8. Surgery was to be performed within 1 week after the end of radiochemotherapy. Results: Twenty-six patients completed all preoperative radiochemotherapy as scheduled; all patients underwent surgery. Dose-limiting toxicity was diarrhea Grade 3 occurring at dose level 6 (105 mg/m2). Hematotoxicity was mild, with only 1 patient experiencing Grade 3 neutropenia. Postoperative complications (30 days) occurred in 7 patients, with an anastomotic leak rate of 22%. Conclusions: The recommended Phase II dose of CPT-11 in this setting is 90 mg/m2/week. Further Phase II exploration at this dose is warranted. © 2003 Elsevier Inc.

Disciplines :

Oncology
Hematology

Author, co-author :

Voelter, V

Stupp, R

Matter, M

Gillet, M

Bouzourene, H

Leyvraz, S

COUCKE, Philippe ; University Hospital CHUV > Radiothérapie

Language :

English

Title :

Preoperative hyperfractionated acclerated radiotherapy (HART) and concomittant CPT-11 in advanced rectal carcinoma. A phase I study.

Publication date :

2003

Journal title :

International Journal of Radiation, Oncology, Biology, Physics

ISSN :

0360-3016

eISSN :

1879-355X

Publisher :

Elsevier Science, Tarrytown, United States - New York

Volume :

Issue :

Pages :

1288-1294

Peer reviewed :

Peer Reviewed verified by ORBi

Available on ORBi :

since 15 July 2009

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