Status:
NOT_YET_RECRUITING
HYpofractionated Pelvic Radiotherapy for Advanced Cervical Cancers INeligible for ChemoTherapy
Lead Sponsor:
University of Santo Tomas Hospital, Philippines
Collaborating Sponsors:
Philippine Council for Health Research & Development
Conditions:
Locally Advanced Cervical Carcinoma
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
BACKGROUND: For patients with locally advanced cervical cancer (LACC) ineligible for concurrent chemotherapy, radiotherapy (RT) alone achieves complete response rate (CRR) \<70% and long-term locoregi...
Detailed Description
SAMPLE SIZE CALCULATION: CRR with chemoradiotherapy based on a meta-analysis in 2017 is about 80%; with advanced RT techniques, based on a multi-center, prospective study, local control rate \>90% co...
Eligibility Criteria
Inclusion
- Females aged ≥18 years
- Histologically confirmed cervical squamous, adeno-, or adenosquamous carcinoma
- 2018 Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) Stage IIIA-IIIC1, IVA
- Pelvic nodal metastases (for the phase 1 cohorts)
- Contraindication to chemotherapy
- Brachytherapy candidate
- World Health Organization (WHO)/ECOG performance status of ≤2
- Life expectancy of at least 12 weeks
- Adequate bone marrow function: Absolute neutrophil count ≥1,500 cell/mm3; Platelets ≥100,000 cell/mm3; Hemoglobin ≥10.0 g/dL; Leukocyte count ≥4,000 cell/mm3
Exclusion
- Other histology (small cell, neuroendocrine, lymphoma, sarcoma, etc.)
- 2018 FIGO Stage IIIC2 (para-aortic nodal metastases)
- Clinical and/or radiologic evidence of metastatic disease
- History of another malignancy except for the following: malignancy treated with curative intent and with no known active disease ≥5 years and of low potential risk for recurrence; adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; adequately treated carcinoma-in-situ without evidence of disease
- Pregnancy
- Uncontrolled concurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease, serious chronic GI conditions associated with diarrhea (including Crohn's disease or ulcerative colitis), or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events or compromise the ability of the patient to give written informed consent
- Presence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse
- Prior hysterectomy
- Prior treatment for cervical cancer
- Prior pelvic radiotherapy
- Concomitant anti-cancer therapy
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2030
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT05210270
Start Date
January 1 2024
End Date
March 1 2030
Last Update
January 31 2023
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