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

NCT01180504 | Unknown Phase 2 DMC

• 1 other identifier: OVAR-IMRT-02
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Ovarian Cancer; Tubal Carcinoma; Primary Peritoneal Carcinoma

Keywords

ovarian cancer; whole-abdominal radiotherapy; consolidation treatment; helical tomotherapy

Outcome Measures

Primary Outcomes (1)

• compatibility of the treatment

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

  Beginning of radiotherapy till 6 weeks after its completion

Secondary Outcomes (7)

• Rate of incomplete radiotherapy

  4 weeks

• Rate of delayed radiotherapy

  4 weeks

• Acute toxicity

  From the beginning of radiotherapy till 6 weeks after its completion

• Late Toxicity

  6 weeks -3 years after the completion of radiotherapy

• Overall survival

  3 years

Interventions

intensity-modulated whole-abdominal radiotherapy RADIATION

Consolidation intensity-modulated whole-abdominal radiotherapy using helical tomotherapy to a total dose of 30 Gy in 1.5 Gy fractions

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Heidelberg: lead
• Deutsche Krebshilfe e.V., Bonn (Germany): collaborator

Study Sites (1)

Department of Radiation Oncology, University of Heidelberg

Heidelberg, 69120, Germany

RECRUITING

Related Publications (3)

• Rochet N, Sterzing F, Jensen AD, Dinkel J, Herfarth KK, Schubert K, Eichbaum MH, Schneeweiss A, Sohn C, Debus J, Harms W. Intensity-modulated whole abdominal radiotherapy after surgery and carboplatin/taxane chemotherapy for advanced ovarian cancer: phase I study. Int J Radiat Oncol Biol Phys. 2010 Apr;76(5):1382-9. doi: 10.1016/j.ijrobp.2009.03.061. Epub 2009 Jul 21.

  PMID: 19628341 BACKGROUND

• Arians N, Kieser M, Benner L, Rochet N, Schroder L, Katayama S, Herfarth K, Schubert K, Schneeweiss A, Sohn C, Lindel K, Debus J. 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.

  PMID: 31639066 DERIVED

• Rochet N, Kieser M, Sterzing F, Krause S, Lindel K, Harms W, Eichbaum MH, Schneeweiss A, Sohn C, Debus J. Phase II study evaluating consolidation whole abdominal intensity-modulated radiotherapy (IMRT) in patients with advanced ovarian cancer stage FIGO III--the OVAR-IMRT-02 Study. BMC Cancer. 2011 Jan 28;11:41. doi: 10.1186/1471-2407-11-41.

  PMID: 21276234 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Andreas Schneeweiss, MD

  Department of Gyneacology and Obstetrics, Unversity of Heidelberg

  PRINCIPAL INVESTIGATOR

• Juergen Debus, MD, PhD

  Department of Radiation Oncology, University of Heidelberg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalie Rochet, MD

CONTACT

0049 6221 56 8202; nathalie.rochet@med.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 11, 2010
• First Posted: August 12, 2010
• Study Start: August 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2016
• Last Updated: August 12, 2010

Record last verified: 2010-08

Locations

DE (1)