Chemotherapy / Radiotherapy in Uterine Cervical Neoplasms

NCT03238261CompletedNAINTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Instituto Nacional de Cancerologia, Columbia

Enrollment

147

Start Date

2007-08-01

Completion Date

2012-02-01

Study Type

INTERVENTIONAL

Official Title

CHEMOTHERAPY AND CONCOMITANT RADIOTHERAPY VS. RADIOTHERAPY IN THE TREATMENT OF PATIENTS WITH STAGE IIIB UTERINE CANCER

Interventions

Chemotherapy and concomitant radiotherapy

Conditions

Uterine Cervical Neoplasms

Eligibility

Age Range

18 Years+

Sex

ALL

Inclusion Criteria:

* Women between 18 and 80 years old, diagnosed with uterine squamous cell cancer or stage IIIB adenocarcinoma (FIGO) with ECOG equal 1 or less and a Karnofsky equal or more than 70%.

Exclusion Criteria:

* Having a concomitant or previous neoplasia, except for patients with skin tumors not associated to melanomas, platelet count under 100.000, hemoglobin levels of 10 gr/dl or above before starting the first radiotherapy session, patients with recurrent invasive uterine carcinoma, patients with compromised para aortic lymph nodes, patients with active and non controlled pelvic infection by the beginning of the treatment, creatinine depuration less than 45 ml/min confirmed with glomerular filtration rate less than 45 ml/min, neutrophils count less than 1,500/ml, and pregnant or nursing woman.

Outcome Measures

Primary Outcomes

Survival rate

the disease free survival rate

Time frame: 3 years

Secondary Outcomes

The response to treatment in terms of locoregional control of the disease

efficacy

Time frame: 3 years

Events adverse

4\. Compare the appearance of severe and non severe adverse events directly related to the treatment in both intervention groups.

Time frame: 3 years