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

• Status: Unknown status
• Trial end date: 2018-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Treatments: Nedaplatin

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.