NCT00122746

Brief Summary

The researchers plan:

  • To undertake clinical studies of radiotherapy with or without the administration of the chemotherapeutic agent cisplatin, known to be a radiosensitizer;
  • To perform pre-clinical studies of the radiosensitivity of human fibroblasts and cervical cancer cell lines in culture, with or without the addition of various HIV proteins or protease inhibitors, in order to determine the extent of any cellular radiosensitizing properties of these molecules;
  • To develop strategies for sensitizing tumour cells to radiation, specifically by down-regulating specific viral proteins that are known to be factors associated with resistance to radiotherapy.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
322

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
5 countries

5 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

December 1, 2004

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 22, 2005

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Last Updated

October 13, 2011

Status Verified

October 1, 2011

Enrollment Period

7.5 years

First QC Date

July 19, 2005

Last Update Submit

October 12, 2011

Conditions

Cancer of the Cervix

Keywords

Cervical CancerAIDSExternal Beam RadiotherapyBrachytherapyCisplatin

Outcome Measures

Primary Outcomes (1)

  • 3 year recurrence free survival

    3 years

Secondary Outcomes (6)

  • Incidence of Grade 3 acute toxicity

    3 months

  • Pelvic control rates

    3 years

  • Tumour response at 3 months.

    3 months

  • Cancer specific survival rates.

    3 years

  • Overall survival rates.

    3 years

  • +1 more secondary outcomes

Study Arms (2)

Radiotherapy alone

ACTIVE COMPARATOR

EBRT pelvis 46 Gy, 4 field box technique + ICBT LDR 1x30 Gy/A or HDR 3x8 Gy/A

Radiation: Radiotherapy alone

Radiotherapy plus Chemotherapy

EXPERIMENTAL

EBRT pelvis 46 Gy, 4 field box technique + ICBT LDR 1x30 Gy/A or HDR 3x8 Gy/A + weekly cisplatin 30 mg/m2 during EBRT

Radiation: Radiotherapy with cisplatin

Interventions

Radiotherapy aloneRADIATION

EBRT pelvis 46 Gy 4 field box technique + ICBT LDR 1x30 Gy/A or HDR 3x8 Gy/A

Radiotherapy alone
Radiotherapy with cisplatinRADIATION

EBRT pelvis 46 Gy 4 field box technique + ICBT LDR 1x30 Gy/A or HDR 3x8 Gy/A + weekly cisplatin 30 mg/m2 during EBRT

Radiotherapy plus Chemotherapy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cancer of the cervix
  • AIDS

You may not qualify if:

  • Unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Dept. of Atomic Energy, Tata Memorial Centre

Mumbai, India

RECRUITING

Johannesburg Hospital

Johannesburg, South Africa

ACTIVE NOT RECRUITING

Ocean Road Cancer Institute

Dar es Salaam, Tanzania

RECRUITING

Radiotherapy Centre

Kampala, Uganda

RECRUITING

Radiotherapy Centre

Harare, Zimbabwe

ACTIVE NOT RECRUITING

Related Links

MeSH Terms

Conditions

Uterine Cervical NeoplasmsAcquired Immunodeficiency Syndrome

Interventions

RadiotherapyCisplatin

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Eduardo H. Zubizarreta, M.D.

    International Atomic Energy Agency

    STUDY DIRECTOR

Central Study Contacts

Eduardo H. Zubizarreta, M.D.

CONTACT

+43-1-2600e.h.zubizarreta@iaea.org

Study Design

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

Study Record Dates

First Submitted

July 19, 2005

First Posted

July 22, 2005

Study Start

December 1, 2004

Primary Completion

June 1, 2012

Last Updated

October 13, 2011

Record last verified: 2011-10

Locations

TA(1)IN(1)ZA(1)UG(1)ZI(1)