A randomised phase III trial of preoperative chemoradiation versus chemoradiation with weekly cisplatin/gemcitabine in FIGO stages IB2-IIB
| ISRCTN | ISRCTN88773338 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88773338 |
| Secondary identifying numbers | 004/009/OM |
- Submission date
- 28/03/2005
- Registration date
- 06/06/2005
- Last edited
- 03/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Alfonso Duenas-Gonzalez
Scientific
Scientific
Instituto Nacional de Cancerologia
Mexico City
14080
Mexico
| Phone | +52 55 56280486 |
|---|---|
| alfonso_duenasg@yahoo.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | A randomised phase III trial of preoperative chemoradiation versus chemoradiation with weekly cisplatin/gemcitabine in FIGO stages IB2-IIB |
| Study objectives | Cisplatin (with or without 5-FU) concurrent with radiation (external beam and brachytherapy) is the current standard of treatment. We have reported that the combination of cisplatin and gemcitabine is superior in terms of pathological complete response than cisplatin alone when used concurrent to pelvic radiation in IB2, IIA and IIB patients. On the other hand, at least three phase II studies show that neoadjuvant or preoperative (before radical hysterectomy) chemoradiation yields a pathological response rate that exceeds 50% and as a whole the survival appears better than standardly treated with external beam and brachytherapy. Finally, in many centers and many countries brachytherapy equipment and/or human resources are not enough or do not exist at all, therefore patients receive extrafacial hysterectomy instead of brachytherapy. Based on these facts we decided to perform a randomised phase III trial to compare radical hysterectomy versus brachytherapy after external beam radiation with the combination of cisplatin-gemcitabine in both arms (assuming the superiority of cisplatin gemcitabine versus cisplatin). The hypothesis being a superiority of the experimental arm of 10% in survival. The sample size has an alfa of 5% and beta of 80%. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cervical carcinoma |
| Intervention | Patients with non-small cell cervical carcinoma International Federation of Gynecology and Obstetrics (FIGO) staged as IB2, IIA and IIB will be randomized to either: Arm 1: External Beam Radiation 50 Gy plus cisplatin at 40 mg/m^2 and gemcitabine 125 mg/m^2 weekly for six applications followed by standard low-dose rate brachytherapy with Cesium sources. Arm 2: External Beam Radiation 50 Gy plus cisplatin at 40 mg/m^2 and gemcitabine 125 mg/m^2 weekly for six applications followed by radical hysterectomy with pelvic and para-aortic lymphadenectomy. Patients in this arm will receive adjuvant brachytherapy if surgical margins positive. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Cisplatin and gemcitabine |
| Primary outcome measure | Efficacy in terms of overall and progression free-survival |
| Secondary outcome measures | Toxicity of chemoradiation and early and late complications the surgical treatment. |
| Overall study start date | 01/09/2004 |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 366 |
| Total final enrolment | 211 |
| Key inclusion criteria | 1. Histologically confirmed squamous, adenosquamous or adenocarcinoma 2. Untreated 3. International Federation of Gynecology and Obstetrics (FIGO) staged IB2, IIA and IIB 4. Mesurable disease 5. Aged 18 to 70 years 6. Zero to two World Health Organisation (WHO) status performance 7. Normal renal, hepatic and hematological function 8. Negative pregnancy test or biological inability to become pregnant 9. Informed consent |
| Key exclusion criteria | 1. Systemic and/or uncontrolled disease that preclude the use of chemotherapy 2. Pre-existent or concurrent neuropathy of any cause 3. Mental disease 4. Previous malignancy except non-melanoma skin cancer |
| Date of first enrolment | 01/09/2004 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- Mexico
Study participating centre
Instituto Nacional de Cancerologia
Mexico City
14080
Mexico
14080
Mexico
Sponsor information
National Cancer Institute of Mexico (Instituto Nacional de Cancerologia)
Government
Government
San Fernando 22
Tlalpan Mexico City
14080
Mexico
| Phone | +52 55 56280486 |
|---|---|
| aduenasg@incan.edu.mx | |
"ROR" |
https://ror.org/04z3afh10 |
Funders
Funder type
Government
National Cancer Institute of Mexico (Instituto Nacional de Cancerologia)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2013 | 03/05/2019 | Yes | No |
Editorial Notes
03/05/2019: Publication reference and total final enrolment added.
