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

Army Medical University of People's Liberation Army

Status and phase: Unknown; Phase 2

Conditions: Complications; Cervical Cancer

Treatments: Drug: Nedaplatin; Radiation: Pelvic External Radiotherapy; Radiation: 252-Cf Neutron Intracavitary Brachytherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02835404

2012012

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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:

  11. Bilirubin <1.5 times the upper limit of normal (ULN)

  12. ALT , AST and APL≤2.5 × ULN

  13. NEUT≥2.0 × 10^9 / L

  14. PLT ≥ 100 × 10^9 / L

  15. HB≥60g/L

  16. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Concurrent radiochemotherapy Group

Experimental group

Description:

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

Treatment:

Radiation: Pelvic External Radiotherapy

Radiation: 252-Cf Neutron Intracavitary Brachytherapy

Drug: Nedaplatin

Radiotherapy Group

Active Comparator group

Description:

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.

Treatment:

Radiation: Pelvic External Radiotherapy

Radiation: 252-Cf Neutron Intracavitary Brachytherapy