Cancer of the Cervix
Conditions
Keywords
Cervical Cancer, AIDS, External Beam Radiotherapy, Brachytherapy, Cisplatin
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.
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.
Interventions
RADIATIONRadiotherapy alone
EBRT pelvis 46 Gy 4 field box technique + ICBT LDR 1x30 Gy/A or HDR 3x8 Gy/A
RADIATIONRadiotherapy with cisplatin
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
Sponsors
International Atomic Energy Agency
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Cancer of the cervix * AIDS
Exclusion criteria
* Unable to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3 year recurrence free survival | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Pelvic control rates | 3 years |
| Tumour response at 3 months. | 3 months |
| Incidence of Grade 3 acute toxicity | 3 months |
| Overall survival rates. | 3 years |
| Acute and late toxicities after the treatment. | up to 3 years |
| Cancer specific survival rates. | 3 years |
Countries
India, South Africa, Tanzania, Uganda, Zimbabwe
Contacts
Primary ContactEduardo H. Zubizarreta, M.D.
Outcome results
None listed