Adjuvant intensity modulated whole-abdominal radiation therapy for high-risk patients with ovarian cancer FIGO stage III: final results of a prospective phase 2 study

Radiat Oncol. 2019 Oct 21;14(1):179. doi: 10.1186/s13014-019-1381-2.

Abstract

Background: To assess late toxicity, quality of life and oncological outcome after consolidative whole abdominal radiotherapy (WART) following cytoreductive surgery and carboplatin/paclitaxel chemotherapy in high risk patients with advanced ovarian cancer FIGO stage III using IMRT (Intensity modulated radiation therapy).

Methods: The OVAR-IMRT-02 study is a multi-center single-arm phase-II-trial. Twenty patients with optimally debulked ovarian cancer stage FIGO III with complete remission after chemotherapy were treated with intensity modulated WART. A total dose of 30 Gy in 20 fractions was applied to the entire peritoneal cavity. Primary endpoint was treatment tolerability; secondary objectives were acute and chronic toxicities, quality of life, rates of therapy disruption/abortion, progression-free survival (PFS) and overall survival (OS).

Results: All patients completed treatment and 10/20 patients (50%) reached the final study follow-up of 36 months. Late side effects consisted of °1-°2 lower limb edema (44.5%), with one patient (5.6%) showing °3 edema. Three patients (16.7%) showed elevated gamma-Glutamyltransferase. There were no severe late side effects regarding renal or hepatic function or any gastrointestinal toxicity greater than °2. During WART, mean global health status decreased by 18.1 points (95%-CI: 7.1-29.0), but completely normalized after 6 months. The same trend was observed for the function scale scores. Kaplan-Meier-estimated 1-, 2- and 3-year PFS was 74, 51 and 40%, respectively. 1-, 2- and 3-year OS was 89, 83 and 83%, respectively.

Conclusions: Intensity modulated WART after aggressive surgery and carboplatin/paclitaxel chemotherapy is associated with an acceptable risk of acute and late toxicity and minor impact on long-term quality of life. Together with the promising results for PFS and OS, intensity modulated WART could offer a new therapeutic option for consolidation treatment of patients with advanced ovarian cancer.

Trial registration: The study is registered with ClinicalTrials.gov ( NCT01180504 ). Registered 12 August 2010 - retrospectively registered.

Keywords: Consolidation treatment; Oncological outcome; Ovarian cancer; Quality of life; Toxicity; Whole abdominal radiotherapy.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study

MeSH terms

  • Abdomen / radiation effects*
  • Fallopian Tube Neoplasms / pathology
  • Fallopian Tube Neoplasms / radiotherapy*
  • Female
  • Humans
  • Middle Aged
  • Neoplasm Recurrence, Local / pathology
  • Neoplasm Recurrence, Local / radiotherapy*
  • Neoplasm Staging
  • Ovarian Neoplasms / pathology
  • Ovarian Neoplasms / radiotherapy*
  • Peritoneal Neoplasms / pathology
  • Peritoneal Neoplasms / radiotherapy*
  • Prospective Studies
  • Radiotherapy Dosage
  • Radiotherapy, Adjuvant / mortality*
  • Radiotherapy, Intensity-Modulated / methods
  • Radiotherapy, Intensity-Modulated / mortality*
  • Survival Rate

Associated data

  • ClinicalTrials.gov/NCT01180504

Grants and funding