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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02835404
• Other study ID #: 2012012
• 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

• Cervical Cancer
• Complications
• Uterine Cervical Neoplasms

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