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

JRCT ID: jRCTs031180250

Registered date:12/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Uterine cervical cancer
• Date of first enrollment: 08/10/2015
• Target sample size: 55
• Study type: Interventional

Intervention(s)

External beam irradiation, Chemotherapy, Hybrid intracavitary/interstitial brachytherapy

External beam irradiation: whole pelvis irradiation (30Gy/15fr or 30.6Gy/17fr) + central shield (20Gy/10fr or 19.8Gy/11fr)
Systemic chemotherapy: weekly CDDP (40mg/m2)
Hybrid intracavitary/interstitial brachytherapy: starts after the initiation of central shield, 24Gy/4fr

Outcome(s)

Primary Outcome

Phase I part: Rate of acute non-hematologic toxicity greater than grade 3 which is obviously attributed to hybrid brachytherapy

Phase II part: 2-year pelvic relapse-free survival

Secondary Outcome

Phase I part: Pelvic relapse-free survival, overall survival, progression-free survival

Phase II part: dose constraint adherence rate of HBT, 2-year overall survival, 2-year progression-free survival, 2-year metastasis-free survival, the rate of acute toxicity, the rate of late toxicity

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Female

Include 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

Exclude 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

Related Information

• Primary Sponsor: Igaki Hiroshi
• Secondary ID(s): UMIN000019081