A randomised phase III trial of preoperative chemoradiation versus chemoradiation with weekly cisplatin/gemcitabine in FIGO stages IB2-IIB

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN88773338

Enrollment

366

Registered

2005-06-06

Start date

2004-09-01

Completion date

Unknown

Last updated

2019-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical carcinoma Cancer Cervical

Interventions

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 B

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Efficacy in terms of overall and progression free-survival	—

Secondary

Measure	Time frame
Toxicity of chemoradiation and early and late complications the surgical treatment.	—

Countries

Mexico

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026