Pelvic External Combined With 252-Cf Neutron Intracavitary Radiotherapy With or Without Platinum in Treating Advanced Cervical Cancer

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Open Label, Single Centre Clinical Trial of Pelvic External Radiotherapy Combined With 252-Cf Neutron Intracavitary Brachytherapy With or Without Platinum in Treatment of Local Advanced Cervical Cancer

Conditions
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Cervical Cancer, Complications

Intervention / Treatment
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* Drug: Nedaplatin
* Radiation: Pelvic External Radiotherapy
* Radiation: 252-Cf Neutron Intracavitary Brachytherapy


Participation Criteria
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Eligibility Criteria
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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: Bilirubin <1.5 times the upper limit of normal (ULN) ALT , AST and APL≤2.5 × ULN NEUT≥2.0 × 10^9 / L PLT ≥ 100 × 10^9 / L HB≥60g/L 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Concurrent radiochemotherapy Group<br>Concurrent radiochemotherapy with Nedaplatin Pelvic External Radiotherapy: patients received 20 Gy2.0/f, for 25-27f with 8mv-X rays (SSD) 252-Cf Neutron Intracavitary Brachytherapy: total dose of reference point A was 4400cGy, in four times Transvaginal implant sessions during Pelvic External Radiations; Chemotherapy: Nedaplatin(NDP) 30-40mg/m2 iv., on day1, 4weeks as one cycle | Drug: Nedaplatin<br>* Chemotherapy: Nedaplatin(NDP) 30-40mg/m2 iv., on day1, 4weeks as one cycle<br>* Other names: NDP;Radiation: Pelvic External Radiotherapy<br>* patients received 20 Gy2.0/f, for 25-27f (SSD)with 8mv-X rays (SSD)<br>Radiation: 252-Cf Neutron Intracavitary Brachytherapy<br>* total dose of reference point A was 4400cGy, in four times Transvaginal implant sessions during Pelvic External Radiations<br>|
| Active Comparator: Radiotherapy Group<br>patients received Radiotherapy only Pelvic External Radiotherapy: patients received 20 Gy2.0/f, for 25-27f (SSD)with 8mv-X Linear Accelerator SSD 252-Cf Neutron Intracavitary Brachytherapy: total dose of reference point A was 4400cGy, in four times Transvaginal implant sessions during Pelvic External Radiations. | Radiation: Pelvic External Radiotherapy<br>* patients received 20 Gy2.0/f, for 25-27f (SSD)with 8mv-X rays (SSD)<br>Radiation: 252-Cf Neutron Intracavitary Brachytherapy<br>* total dose of reference point A was 4400cGy, in four times Transvaginal implant sessions during Pelvic External Radiations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute toxicity events | chemo-related toxicity as measured by CTCAE v. 4.0, radiation-related toxicity as measured by RTOG/EORTC criteria | Week 5 of Radiation Therapy (RT) | 
| Long-trem toxicity events | chemo-related toxicity as measured by CTCAE v. 4.0, radiation-related toxicity as measured by RTOG/EORTC criteria | through study completion, an average of 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2 Years Overall survial Rate | chemo-related toxicity as measured by CTCAE v. 4.0, radiation-related toxicity | 2 years | 
| 3 Years Overall survial Rate |  | 3 years | 
| 5 Years Overall survial Rate |  | 5 years | 
| Disease-free survival (DFS) |  | through study completion, an average of 3 year | 
| Overall survial (OS) |  | through study completion, an average of 5 year |