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

NCT ID: NCT02835404

Last Updated: 2016-07-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2018-11-30

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.

Conditions

Cervical Cancer; Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Concurrent radiochemotherapy Group

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

Group Type: EXPERIMENTAL

Nedaplatin

Intervention Type: DRUG

Chemotherapy: Nedaplatin(NDP) 30-40mg/m2 iv., on day1, 4weeks as one cycle

Pelvic External Radiotherapy

Intervention Type: RADIATION

patients received 20 Gy2.0/f, for 25-27f (SSD)with 8mv-X rays (SSD)

252-Cf Neutron Intracavitary Brachytherapy

Intervention Type: RADIATION

total dose of reference point A was 4400cGy, in four times Transvaginal implant sessions during Pelvic External Radiations

Radiotherapy Group

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.

Group Type: ACTIVE_COMPARATOR

Pelvic External Radiotherapy

Intervention Type: RADIATION

patients received 20 Gy2.0/f, for 25-27f (SSD)with 8mv-X rays (SSD)

252-Cf Neutron Intracavitary Brachytherapy

Intervention Type: RADIATION

total dose of reference point A was 4400cGy, in four times Transvaginal implant sessions during Pelvic External Radiations

Interventions

Nedaplatin

Chemotherapy: Nedaplatin(NDP) 30-40mg/m2 iv., on day1, 4weeks as one cycle

Intervention Type: DRUG

Pelvic External Radiotherapy

patients received 20 Gy2.0/f, for 25-27f (SSD)with 8mv-X rays (SSD)

Intervention Type: RADIATION

252-Cf Neutron Intracavitary Brachytherapy

total dose of reference point A was 4400cGy, in four times Transvaginal implant sessions during Pelvic External Radiations

Intervention Type: RADIATION

Other Intervention Names

NDP

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Xin Lei, M.D.Prof

M.D, Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xin Lei, M.D

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Chongqing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Xin Lei, M.D

Role: CONTACT

dpxinlei@126.com

+86 023-68757176

Facility Contacts

Xin Lei, M.D

Role: primary

Other Identifiers

2012012

Identifier Type: -

Identifier Source: org_study_id