Cervical Cancer, Complications
Conditions
Brief summary
The objective of this study was to evaluate the efficacy and complication of the treatment of pelvic external combined with 252-Cf neutron intracavitary radiotherapy with or without platinum in local advanced cervical cancer patients in the short and long term.
Interventions
DRUGNedaplatin
Chemotherapy: Nedaplatin(NDP) 30-40mg/m2 iv., on day1, 4weeks as one cycle
RADIATIONPelvic External Radiotherapy
patients received 20 Gy2.0/f, for 25-27f (SSD)with 8mv-X rays (SSD)
RADIATION252-Cf Neutron Intracavitary Brachytherapy
total dose of reference point A was 4400cGy, in four times Transvaginal implant sessions during Pelvic External Radiations
Sponsors
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 1\. To be aged from 18 (including 18) to 65 (including 65), female patient; * 2\. Expected survival ≥6 months * 3\. Pathologically proven diagnosis of squamous carcinoma or adenocarcinoma of the cervix, according to FIGO(International Federation of Gynecology and Obstetrics) staging, appropriate stage for protocol entry, including IIA2, IIB,IIIA,IIIB; * 4\. No patients with distant metastases; * 5\. Measurable target lesions (satisfying the criteria in RECIST 1.1); * 6\. ECOG PS status of 0-2; * 7\. No prior treatment; * 8\. No * 9\. No surgery * 10\. Major organ function has to meet the following criteria: 1. Bilirubin \<1.5 times the upper limit of normal (ULN) 2. ALT , AST and APL≤2.5 × ULN 3. NEUT≥2.0 × 10\^9 / L 4. PLT ≥ 100 × 10\^9 / L 5. HB≥60g/L 6. Serum Cr and urea nitrogen ≤ 1.5 × ULN * 11\. Favorable cardiac functions, no patients with myocardial infarction within half a year, hypertension and coronary disease are well-controlled.
Exclusion criteria
* 1\. Serious heart disease, pulmonary disease, hepatic disease, , renal disease and metabolic disease, or with electrolyte disturbance; * 2\. Allergic to platinum; * 3\. Rejecte to join the study in other conditions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute toxicity events | Week 5 of Radiation Therapy (RT) | chemo-related toxicity as measured by CTCAE v. 4.0, radiation-related toxicity as measured by RTOG/EORTC criteria |
| Long-trem toxicity events | through study completion, an average of 5 year | chemo-related toxicity as measured by CTCAE v. 4.0, radiation-related toxicity as measured by RTOG/EORTC criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 5 Years Overall survial Rate | 5 years | — |
| 2 Years Overall survial Rate | 2 years | chemo-related toxicity as measured by CTCAE v. 4.0, radiation-related toxicity |
| Overall survial (OS) | through study completion, an average of 5 year | — |
| Disease-free survival (DFS) | through study completion, an average of 3 year | — |
| 3 Years Overall survial Rate | 3 years | — |
Countries
China
Contacts
Primary ContactXin Lei, M.D
Outcome results
None listed