Consolidation Whole Abdominal Intensity-Modulated Radiation Therapy (IMRT) in Advanced Ovarian Cancer (OVAR-IMRT-02)

University Hospital Heidelberg

Status and phase

Unknown

Phase 2

Conditions

Tubal Carcinoma

Primary Peritoneal Carcinoma

Ovarian Cancer

Treatments

Radiation: intensity-modulated whole-abdominal radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01180504

OVAR-IMRT-02

Details and patient eligibility

About

The primary objective of this phase-II study is to assess the toxicity of consolidation intensity-modulated whole-abdominal radiotherapy using tomotherapy in patients with advanced optimally debulked stage International Federation of Gynecology and Obstetrics (FIGO) III ovarian cancer with a complete remission after adjuvant chemotherapy.

36 patients will be treated to a total dose of 30 Gy in 1.5 Gy fractions. The planning target-volume includes the entire peritoneal cavity and the pelvic and para-aortal node regions. Intensity-modulated whole-abdominal radiotherapy allows an effective sparing of liver, kidneys and bone-marrow (vertebral bodies and pelvic bones).

Enrollment

36 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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