Clinical trial NCT02835404: Pelvic External Combined With 252-Cf Neutron Intracavitary Radiotherapy With or Without Platinum in Treating Advanced Cervical Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cervical Cancer
Complications
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
First posted: 2016-07-18
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Acute toxicity events
timeFrame: Week 5 of Radiation Therapy (RT)
measure: Long-trem toxicity events
timeFrame: through study completion, an average of 5 year
Secondary outcomes:
measure: 2 Years Overall survial Rate
timeFrame: 2 years
measure: 3 Years Overall survial Rate
timeFrame: 3 years
measure: 5 Years Overall survial Rate
timeFrame: 5 years
measure: Disease-free survival (DFS)
timeFrame: through study completion, an average of 3 year
measure: Overall survial (OS)
timeFrame: through study completion, an average of 5 year
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Study officials:
affiliation: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
name: Xin Lei, M.D
role: PRINCIPAL_INVESTIGATOR
References: