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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02835404
Other study ID # 2012012
Secondary ID
Status Recruiting
Phase Phase 2
First received July 6, 2016
Last updated July 13, 2016
Start date November 2012
Est. completion date November 2018

Study information

Verified date June 2016
Source Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Contact Xin Lei, M.D
Phone +86 023-68757176
Email dpxinlei@126.com
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date November 2018
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Nedaplatin
Chemotherapy: Nedaplatin(NDP) 30-40mg/m2 iv., on day1, 4weeks as one cycle
Radiation:
Pelvic External Radiotherapy
patients received 20 Gy2.0/f, for 25-27f (SSD)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

Locations

Country Name City State
China Daping Hospital and the Research Institute of Surgery of the Third Military Medical University Chongqing

Sponsors (1)

Lead Sponsor Collaborator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) Yes
Primary 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 Yes
Secondary 2 Years Overall survial Rate chemo-related toxicity as measured by CTCAE v. 4.0, radiation-related toxicity 2 years Yes
Secondary 3 Years Overall survial Rate 3 years No
Secondary 5 Years Overall survial Rate 5 years No
Secondary Disease-free survival (DFS) through study completion, an average of 3 year No
Secondary Overall survial (OS) through study completion, an average of 5 year No
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