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

Phase 2

• Conditions: Cervical Cancer; Complications
• Interventions: Radiation: Pelvic External Radiotherapy; Drug: Nedaplatin; Radiation: 252-Cf Neutron Intracavitary Brachytherapy

• Registration Number: NCT02835404
• Lead Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Status Verified: 2016-06
• Study First Submitted: 2016-07-06
• Study First Submitted QC: 2016-07-13
• Last Update Submitted: 2016-07-13
• Study First Posted: 2016-07-18
• Last Update Posted: 2016-07-18
• Primary Completion: 2017-06
• Study Completion: 2018-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiotherapy Group	Pelvic External Radiotherapy	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.
Concurrent radiochemotherapy Group	252-Cf Neutron Intracavitary Brachytherapy	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
Radiotherapy Group	252-Cf Neutron Intracavitary Brachytherapy	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.
Concurrent radiochemotherapy Group	Pelvic External Radiotherapy	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
Concurrent radiochemotherapy Group	Nedaplatin	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

Primary Outcome Measures

Name	Time	Method
Long-trem toxicity events	through study completion, an average of 5 year	chemo-related toxicity as measured by CTCAE v. 4.0, radiation-related toxicity as measured by RTOG/EORTC criteria
Acute toxicity events	Week 5 of Radiation Therapy (RT)	chemo-related toxicity as measured by CTCAE v. 4.0, radiation-related toxicity as measured by RTOG/EORTC criteria

Secondary Outcome Measures

Name	Time	Method
Disease-free survival (DFS)	through study completion, an average of 3 year
5 Years Overall survial Rate	5 years
2 Years Overall survial Rate	2 years	chemo-related toxicity as measured by CTCAE v. 4.0, radiation-related toxicity
Overall survial (OS)	through study completion, an average of 5 year
3 Years Overall survial Rate	3 years

Trial Locations

Locations (1)

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University; 🇨🇳 Chongqing, China