Cancer of the CervixPhase 3NCT00122746
Clinical and Experimental Studies to Improve Radiotherapy Outcome in AIDS Cancer Patients
A Phase 3 study testing Radiotherapy alone and Radiotherapy with cisplatin in people with Cancer of the Cervix, run by International Atomic Energy Agency at 5 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cancer of the Cervix
- What is being tested?
- Radiotherapy alone and Radiotherapy with cisplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 322 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Dec 2004to Jun 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cancer of the cervix
- AIDS
Who cannot join
- Unable to give informed consent
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
India1 site, 1 recruiting
- Recruiting
Dept. of Atomic Energy, Tata Memorial Centre
Mumbai
Reena Engineer, MD, reena_engineer@rediffmail.com
Reena Engineer, MD
South Africa1 site
- Active, not recruiting
Johannesburg Hospital
Johannesburg
Tanzania1 site, 1 recruiting
- Recruiting
Ocean Road Cancer Institute
Dar es Salaam
Twalib Ngoma, MD, ngoma@uccmail.co.tz
Twalib Ngoma, MD
Uganda1 site, 1 recruiting
- Recruiting
Radiotherapy Centre
Kampala
Joseph Kigula, MD, jbkigula@yahoo.com
Joseph Kigula, MD
About this study
Official title: Doctoral CRP on Clinical and Experimental Studies to Improve Radiotherapy Outcome in AIDS Cancer Patients
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.
Read the detailed description
Clinical study addresses the question of whether radiotherapy plus weekly cisplatin offers an advantage over the same radiotherapy given alone in AIDS patients with cervix cancer. External beam radiotherapy is used with 50 Gy in 25 daily fractions (last interim analysis, October 2005) suggested lowering the total dose down to 46 Gy in 23 daily fractions). Brachytherapy component was specified as either 30 Gy of LDR in a single fraction or 3 fractions of 8 Gy using HDR. Cisplatin was administered weekly at a dose of 30 mg/sqm.
- Conditions
- Cancer of the Cervix
- Being tested
- Radiotherapy alone, Radiotherapy with cisplatin
- Keywords
- Cervical Cancer, AIDS, External Beam Radiotherapy, Brachytherapy, Cisplatin
- Medical subject headings
- Uterine Cervical Neoplasms, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiotherapy aloneRadiation
EBRT pelvis 46 Gy 4 field box technique + ICBT LDR 1x30 Gy/A or HDR 3x8 Gy/A
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
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy alone | Active comparator | EBRT pelvis 46 Gy, 4 field box technique + ICBT LDR 1x30 Gy/A or HDR 3x8 Gy/A Receives: 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 Receives: Radiation: Radiotherapy with cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 year recurrence free survival
Measured: 3 years
Secondary outcomes (6)
Incidence of Grade 3 acute toxicity
Measured: 3 months
Pelvic control rates
Measured: 3 years
Tumour response at 3 months.
Measured: 3 months
Cancer specific survival rates.
Measured: 3 years
Overall survival rates.
Measured: 3 years
Acute and late toxicities after the treatment.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2005 (estimated)
- Study startDec 2004
- Primary completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of the CervixStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 322 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Atomic Energy Agency
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Eduardo H. Zubizarreta, M.D., Study director, International Atomic Energy Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00122746
- Sponsor's protocol ID
- E33022
- Status last verified
- Oct 2011
- First submitted
- 19 Jul 2005
- Last updated
- 13 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doctoral CRP on Clinical and Experimental Studies to Improve Radiotherapy Outcome in AIDS Cancer Patients
- ClinicalTrials.gov ID
- NCT00122746
- Acronym / sponsor ID
- E33022
- Conditions
- Cancer of the Cervix
- Keywords
- Cervical Cancer, AIDS, External Beam Radiotherapy, Brachytherapy, Cisplatin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 322 participants (estimated)
- Lead sponsor
- International Atomic Energy AgencyOther government
- Study start
- Dec 2004
- Primary completion
- Jun 2012 (estimated)
- First posted
- 22 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Clinical study addresses the question of whether radiotherapy plus weekly cisplatin offers an advantage over the same radiotherapy given alone in AIDS patients with cervix cancer. External beam radiotherapy is used with 50 Gy in 25 daily fractions (last interim analysis, October 2005) suggested lowering the total dose down to 46 Gy in 23 daily fractions). Brachytherapy component was specified as either 30 Gy of LDR in a single fraction or 3 fractions of 8 Gy using HDR. Cisplatin was administered weekly at a dose of 30 mg/sqm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy alone | Active comparator | Radiation: Radiotherapy aloneEBRT pelvis 46 Gy, 4 field box technique + ICBT LDR 1x30 Gy/A or HDR 3x8 Gy/A |
| Radiotherapy plus Chemotherapy | Experimental | Radiation: Radiotherapy with cisplatinEBRT pelvis 46 Gy, 4 field box technique + ICBT LDR 1x30 Gy/A or HDR 3x8 Gy/A + weekly cisplatin 30 mg/m2 during EBRT |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cancer of the cervix
- AIDS
Key exclusion criteria (1 listed)
- Unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiotherapy aloneEBRT pelvis 46 Gy 4 field box technique + ICBT LDR 1x30 Gy/A or HDR 3x8 Gy/A | Radiation | Radiotherapy alone |
| Radiotherapy with cisplatinEBRT 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 plus Chemotherapy |
Primary outcome
3 year recurrence free survival
Time frame: 3 years
6 secondary outcomes
Incidence of Grade 3 acute toxicity
Time frame: 3 months
Pelvic control rates
Time frame: 3 years
Tumour response at 3 months.
Time frame: 3 months
Cancer specific survival rates.
Time frame: 3 years
Overall survival rates.
Time frame: 3 years
Acute and late toxicities after the treatment.
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2011.
- International Atomic Energy Agency. Research Contracts AdministrationLink provided by the sponsor.
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Cervical Cancer
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Enrolling by invitationObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo H. Zubizarreta, M.D. study director
International Atomic Energy Agency
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Radiotherapy alone and Radiotherapy with cisplatin in people with Cancer of the Cervix, run by International Atomic Energy Agency at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in India, South Africa, Tanzania, Uganda, Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eduardo H. Zubizarreta, M.D. (+43-1-2600 ext. 22401, e.h.zubizarreta@iaea.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3 year recurrence free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2011.