Condition category
Cancer
Date applied
28/03/2005
Date assigned
06/06/2005
Last edited
17/08/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alfonso Duenas-Gonzalez

ORCID ID

Contact details

Instituto Nacional de Cancerologia
Mexico City
14080
Mexico
+52 55 56280486
alfonso_duenasg@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

004/009/OM

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Phase III

Drug names

Cisplatin and gemcitabine

Primary outcome measures

Efficacy in terms of overall and progression free-survival

Secondary outcome measures

Toxicity of chemoradiation and early and late complications the surgical treatment.

Overall trial start date

01/09/2004

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

366

Participant 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

Recruitment start date

01/09/2004

Recruitment end date

31/12/2006

Locations

Countries of recruitment

Mexico

Trial participating centre

Instituto Nacional de Cancerologia
Mexico City
14080
Mexico

Sponsor information

Organisation

National Cancer Institute of Mexico (Instituto Nacional de Cancerologia)

Sponsor details

San Fernando 22
Tlalpan Mexico City
14080
Mexico
+52 55 56280486
aduenasg@incan.edu.mx

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

National Cancer Institute of Mexico (Instituto Nacional de Cancerologia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes