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

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

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.

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.