A phase I/II study of hybrid brachytherapy for locally advanced cervical carcinoma

Phase 1

• Conditions: terine cervical cancer

• Registration Number: JPRN-jRCTs031180250
• Lead Sponsor: Igaki Hiroshi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-12
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 55

Inclusion Criteria

Primary registration
1) Pathologically proven squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix
2) Age between 20 and 75 years old
3) FIGO stage IB2, IIA2, IIB, IIIA, IIIB, IVA(bladder invasion)
4) Patients for whom primary radiation therapy is planned
5) Tumor width greater than 5 cm assessed by pretreatment image examination
6) ECOG (Zubrod) performance status 0-2
7) No prior radiation therapy, chemotherapy, nor surgery for cervical cancer
8) Patients with sufficient organ function
- neutrophil count greater than 2,000/mm3
- hemoglobin greater than 8g/dL
- platelets greater than 50,000/mm3
- total bilirubin lower than 1.5mg/dL
- AST (GOT) and ALT (GPT) lower than 100 IU/L
-serum creatinine lower than 1.2mg/dL
-creatinine clearance higher than 60mL/min
9) It is possible to stop taking or do not intake any anticoagulant or antiplatelet
10) No prior chemotherapy or no prior abdominopelvic irradiation
11) Patient must provide study-specific informed consent prior to study entry

Secondary registration
1) Primary registration was already done
2) Tumor width greater than 4 cm assessed by pre-HBT image examination
3) ECOG (Zubrod) performance status 0-2
4) Neutrophil greater than 2,000/mm3 and platelet greater than 50,000/mm3

Exclusion Criteria

Primary registration
1) Patients with para-aortic lymph node metastasis.
2) Uncontrollable diabetes mellitus
3) Uncontrollable hypertension
4) Unstable angina pectoris or transmural myocardial infarction within the last 6 months
5) Prior invasive malignancy unless disease free for a minimum of 5 years. For example, carcinoma in situ of the breast, oral cavity, or esophagus are all permissible.
6) Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
7) Body temperature greater than 38 degree Celsicus
8) Psychiatric comorbidities or problems hinders enrollment of the study
9) Active ulcerative colitis or Crohn's disease
10) Active systemic lupus erythematosus or scleroderma
11) Allergy to local anesthesia
12) Attending physician believes the patient is not suitable for the study
13) Positive for hepatitis B Surface antigen

Secondary registration
1) Patients with FIGO IIIA and after 30/30.6 Gy of pelvic irradiation, still depth of the vaginal invasion exceeds 5 mm and cannot be handled with intracavitary brachytherapy
2) Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
3) Body temperature greater than 38 degree Celsicus

Study & Design

• Study Type: Interventional
• Study Design: Not specified