NCT00348738

Brief Summary

The purpose of this study is to determine whether an increase of blood haemoglobin levels through the substitution of erythropoietin during radiotherapy treatment of cervix cancer patients results in improvement for disease specific survival, tumor response and local control.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2000

Longer than P75 for phase_3

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2000

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 6, 2006

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

November 2, 2007

Status Verified

October 1, 2007

First QC Date

July 5, 2006

Last Update Submit

October 31, 2007

Conditions

Cervix Cancer

Keywords

radiotherapyclinical trialerythropoietincervix cancerPhase III2 Arms

Outcome Measures

Primary Outcomes (3)

  • remission rate 3 months after completion of the radiation therapy

    3 months

  • local control rate

    2 years

  • Disease specific survival

    2 years

Secondary Outcomes (2)

  • The extent of increase in hemoglobin levels during the treatment with erythropoietin.

    Duration of treatment

  • The need of transfusion during the treatment.

    Duration of treatment

Study Arms (2)

1

EXPERIMENTAL

Patients assigned to this group are receiving Erythropoietin medication

Drug: Erythropoietin

2

NO INTERVENTION

control group receiving no treatment

Interventions

ErythropoietinDRUG

Administration of 10.000 I.U Erythropoeitin SQ 3x/week, two weeks prior to radiation therapy until a haemoglobin concentration of \>14g/dl, \<15g/dl is reached or until the end of the radiation therapy.

1

Eligibility Criteria

Age19 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histologically proven cervix cancer (FIGO stage I-IVA)
  • Age of 19-80 years
  • initial blood level of hemoglobin \<= 14 g/dl
  • patients who gave their informed consent

You may not qualify if:

  • Karnofsky-Index \< 50 %
  • known intolerance of erythropoietin
  • FIGO stage IVB
  • blood transfusion within the last four weeks
  • neoadjuvant chemotherapy
  • previous radiation therapy of the abdomen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Department of Radiotherapy-University Hospital of Innsbruck

Innsbruck, A-6020, Austria

Location

Department of Radiotherapy-University Hospital of Salzburg

Salzburg, A-5020, Austria

Location

Department of Radiotherapy and Radiobiology-Medical University of Vienna

Vienna, A-1090, Austria

Location

Department of Radiotherapy-Hospital of Hietzing

Vienna, A-1130, Austria

Location

Related Publications (3)

  • Winter WE 3rd, Maxwell GL, Tian C, Sobel E, Rose GS, Thomas G, Carlson JW. Association of hemoglobin level with survival in cervical carcinoma patients treated with concurrent cisplatin and radiotherapy: a Gynecologic Oncology Group Study. Gynecol Oncol. 2004 Aug;94(2):495-501. doi: 10.1016/j.ygyno.2004.04.008.

    PMID: 15297194BACKGROUND

  • Vaupel P, Thews O, Mayer A, Hockel S, Hockel M. Oxygenation status of gynecologic tumors: what is the optimal hemoglobin level? Strahlenther Onkol. 2002 Dec;178(12):727-31. doi: 10.1007/s00066-002-1081-x.

    PMID: 12491062BACKGROUND

  • Knocke TH, Weitmann HD, Feldmann HJ, Selzer E, Potter R. Intratumoral pO2-measurements as predictive assay in the treatment of carcinoma of the uterine cervix. Radiother Oncol. 1999 Nov;53(2):99-104. doi: 10.1016/s0167-8140(99)00139-5.

    PMID: 10665785BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Erythropoietin

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Richard Poetter, Prof., M.D.

    Department of Radiotherapy and Radiobiology-Medical University of Vienna

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 5, 2006

First Posted

July 6, 2006

Study Start

July 1, 2000

Study Completion

July 1, 2009

Last Updated

November 2, 2007

Record last verified: 2007-10

Locations

AU(4)