Status:
WITHDRAWN
Curcumin in Advanced Cervical Cancer
Lead Sponsor:
Instituto Nacional de Cancerologia, Columbia
Conditions:
Cervical Cancer, Stage IIB
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
Determine the efficacy and safety of turmeric in the treatment of patients with advanced cervical cancer. Efficacy will be determined through radiological and histopathological criteria through the ra...
Detailed Description
A placebo-controlled phase II clinical trial will be developed in patients with advanced cervical cancer who have an indication for radiotherapy. Those who accept to participate will receive the stand...
Eligibility Criteria
Inclusion
- Women aged 18 years or older
- Voluntary acceptance of participation and signing of informed consent
- Radiotherapy indication
- Histological confirmation of squamous cervical cancer or histologically confirmed adenocarcinoma
- Stage IIB - VAT
- Chemo-radiation indication with Cisplatin, Cisplatin/fluorouracil, Carboplatin (if cisplatin intolerant)
- ECOG equal to or less than 1 and a Karnofsky index equal to or greater than 70%.
Exclusion
- Being pregnant or breastfeeding
- Presence of second concomitant neoplasia
- Any previous surgical, radiotherapy or chemotherapy treatment.
- Diagnosis of invasive recurrent carcinoma of the cervix
- Receive anticoagulant therapy
- Receive immunosuppression therapy
- Presence of coagulation disorders, such as platelet count less than 100,000 at the time of the joint evaluation, absolute neutrophil count less than 1,500 / ml
- Presence of signs of systemic infection
- Renal failure, creatinine clearance less than 45 ml/min confirmed with glomerular filtration less than 45 ml / min; evidence of unilateral renal exclusion
- Patients with uncontrolled metabolic disease
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04294836
Start Date
December 1 2021
End Date
December 31 2023
Last Update
December 7 2022
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