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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concurrent radiochemotherapy Group | Experimental | 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 |
|
| Radiotherapy Group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nedaplatin | Drug | Chemotherapy: Nedaplatin(NDP) 30-40mg/m2 iv., on day1, 4weeks as one cycle |
|
| 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 |
| 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 |
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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:
11. Favorable cardiac functions, no patients with myocardial infarction within half a year, hypertension and coronary disease are well-controlled.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Lei, M.D | Contact | +86 023-68757176 | dpxinlei@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Xin Lei, M.D | Daping Hospital and the Research Institute of Surgery of the Third Military Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daping Hospital and the Research Institute of Surgery of the Third Military Medical University | Recruiting | Chongqing | China |
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| Pelvic External Radiotherapy | Radiation | patients received 20 Gy2.0/f, for 25-27f (SSD)with 8mv-X rays (SSD) |
|
| 252-Cf Neutron Intracavitary Brachytherapy | Radiation | total dose of reference point A was 4400cGy, in four times Transvaginal implant sessions during Pelvic External Radiations |
|
| 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 |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| C053989 | nedaplatin |
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