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Consolidation Intensity-Modulated Whole Abdominal Radiotherapy for High-Risk Patients With Ovarian Cancer Stage FIGO III


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer, Tubal Carcinoma, Primary Peritoneal Carcinoma

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Trial Information

Consolidation Intensity-Modulated Whole Abdominal Radiotherapy for High-Risk Patients With Ovarian Cancer Stage FIGO III


Inclusion Criteria:



- histologically confirmed ovarian cancer or tube cancer or primary peritoneal
carcinoma stage FIGO III

- primary optimal debulking surgery

- postoperative gross residual tumor ≤ 1cm ( R0, R1 oder R2 < 1cm situation)

- adjuvant chemotherapy with platin and taxane

- complete remission after chemotherapy

- Karnofsky performance score > 60

- patients >18 years of age

- written informed consent

Exclusion Criteria:

- stage FIGO I or II

- stage III with postoperative gross residual tumor > 1cm

- stage FIGO IV

- recurrence situation

- delayed wound healing post laparotomy

- leucopenia <2000/ml before radiotherapy

- thrombocytopenia <75000/ml before radiotherapy

- clinically active renal, hepatic, cardiac, metabolic, respiratory, coagulation or
hematopoietic disease

- status post pelvic or abdominal radiotherapy

- status post other cancer disease in the past 5 years (cervical cancer in situ, basal
cell carcinoma, squamous cell carcinoma of the skin are excluded)

- participation in another clinical trial

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

compatibility of the treatment

Outcome Description:

Therapy compatibility defined as non-occurrence of life-threatening grade 4 (CTCAE v3.0) acute toxicity

Outcome Time Frame:

Beginning of radiotherapy till 6 weeks after its completion

Safety Issue:

Yes

Principal Investigator

Andreas Schneeweiss, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Gyneacology and Obstetrics, Unversity of Heidelberg

Authority:

Germany: Federal Office for Radiation Protection

Study ID:

OVAR-IMRT-02

NCT ID:

NCT01180504

Start Date:

August 2010

Completion Date:

August 2016

Related Keywords:

  • Ovarian Cancer
  • Tubal Carcinoma
  • Primary Peritoneal Carcinoma
  • ovarian cancer
  • whole-abdominal radiotherapy
  • consolidation treatment
  • helical tomotherapy
  • Carcinoma
  • Ovarian Neoplasms

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