Clinical trial · Interventional
Concurrent Treatment of Squamous Cell Carcinoma or Adenocarcinoma of the Cervix With CIGB-300 for Local Application
Open Clinical Trial, Uncontrolled in Patients Bearing Squamous Cell Carcinoma or Adenocarcinoma of the Cervix Stage IIA and IIB FIGO Classification Treated With Radiotherapy External Endocavitary Brachytherapy + Concurrent Hemotherapy Weekly Systemic and Local Application of CIGB-300 Dose Escalation
NCT01639625CI-TRIAL-00023331completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
They include patients who are candidates to complete concurrent treatment with endocavitary brachytherapy External radiation therapy + more QT based weekly cisplatin.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Cervix | Cervical Adenocarcinoma | ALIAS | 0.90 |
| Squamous Cell Carcinoma of the Cervix | Cervical Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CIGB300 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CIGB300
- interventionNames
- Drug: CIGB300
Primary outcomes (1)
- measure
- Number of patients with presence or absence of grade 3 or 4 adverse events related to the study drug, in each dose level
- timeFrame
- Up to 2 years
Secondary outcomes (2)
- measure
- Number of patients with local relapses
- timeFrame
- Up to 2 years
- measure
- Number of patients with distant relapses
- timeFrame
- Up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Stages IIA and IIB FIGO classification. * Age between 21 to 70 years. * ECOG performance status 0-1. * No history of another neoplastic disease. * Value of Hemoglobin ≥ 9 g / l. * Total leukocyte count ≥ 3.0 x 109 / L. * Absolute neutrophil count ≥ 1.5 x 109 / L. * Platelets ≥ 100,000 x mm3. * Total bilirubin ≤ 1.5 times ULN, SGOT and SGPT ≤ 2.5 times upper limit of normal. * Creatinine ≤ 2 mg / dL and creatinine clearance calculated ≥ 60 ml / min(according to Cockcroft-Gault formula) * Patients of childbearing age who are using an adequate contraception method during treatment to prevent pregnancy. * Life expectancy ≥ 12 months * Measurable disease * Informed consent signed by the patient Exclusion Criteria: * Pregnancy and lactation period. * Presence of lymph node metastases or hematogenous extrapelvic known. * Uncontrolled intercurrent diseases, including active infection, symptomatic congestive heart failure, unstable angina or cardiac arrhythmia and psychiatric illness involving incompetence of the patient. * Other malignancies, with the exception of basal cell carcinoma or other tumor that appropriate treatment is received showing a disease-free period ≥ 5 years. * Hepatitis B or C active, positive serology for HIV. * Atopy history of severe / severe asthma. * A history of autoimmune disease. * Presence of significant abnormalities in ECG performed within 14 days prior to admission. * Diseases that prevent the patient give informed consent or their ability to collaborate in the trial. * Participating in another clinical trial "
References
Publications (0)
Data not yet available
No reference posted for this study.