Back to resultsPelvic External Combined With 252-Cf Neutron Intracavitary Radiotherapy With or Without Platinum in Treating Advanced Cervical Cancer
Primary Purpose
Cervical Cancer, Complications
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Nedaplatin
Pelvic External Radiotherapy
252-Cf Neutron Intracavitary Brachytherapy
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Cancer
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:
- Bilirubin <1.5 times the upper limit of normal (ULN)
- ALT , AST and APL≤2.5 × ULN
- NEUT≥2.0 × 10^9 / L
- PLT ≥ 100 × 10^9 / L
- HB≥60g/L
- 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.
Sites / Locations
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Concurrent radiochemotherapy Group
Radiotherapy Group
Arm 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
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.
Outcomes
Primary Outcome Measures
Acute toxicity events
chemo-related toxicity as measured by CTCAE v. 4.0, radiation-related toxicity as measured by RTOG/EORTC criteria
Long-trem toxicity events
chemo-related toxicity as measured by CTCAE v. 4.0, radiation-related toxicity as measured by RTOG/EORTC criteria
Secondary Outcome Measures
2 Years Overall survial Rate
chemo-related toxicity as measured by CTCAE v. 4.0, radiation-related toxicity
3 Years Overall survial Rate
5 Years Overall survial Rate
Disease-free survival (DFS)
Overall survial (OS)
Full Information
NCT ID
NCT02835404
First Posted
July 6, 2016
Last Updated
July 13, 2016
Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02835404
Brief Title
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
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
November 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Complications
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Concurrent radiochemotherapy Group
Arm Type
Experimental
Arm 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
Arm Title
Radiotherapy Group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Nedaplatin
Other Intervention Name(s)
NDP
Intervention Description
Chemotherapy: Nedaplatin(NDP) 30-40mg/m2 iv., on day1, 4weeks as one cycle
Intervention Type
Radiation
Intervention Name(s)
Pelvic External Radiotherapy
Intervention Description
patients received 20 Gy2.0/f, for 25-27f (SSD)with 8mv-X rays (SSD)
Intervention Type
Radiation
Intervention Name(s)
252-Cf Neutron Intracavitary Brachytherapy
Intervention Description
total dose of reference point A was 4400cGy, in four times Transvaginal implant sessions during Pelvic External Radiations
Primary Outcome Measure Information:
Title
Acute toxicity events
Description
chemo-related toxicity as measured by CTCAE v. 4.0, radiation-related toxicity as measured by RTOG/EORTC criteria
Time Frame
Week 5 of Radiation Therapy (RT)
Title
Long-trem toxicity events
Description
chemo-related toxicity as measured by CTCAE v. 4.0, radiation-related toxicity as measured by RTOG/EORTC criteria
Time Frame
through study completion, an average of 5 year
Secondary Outcome Measure Information:
Title
2 Years Overall survial Rate
Description
chemo-related toxicity as measured by CTCAE v. 4.0, radiation-related toxicity
Time Frame
2 years
Title
3 Years Overall survial Rate
Time Frame
3 years
Title
5 Years Overall survial Rate
Time Frame
5 years
Title
Disease-free survival (DFS)
Time Frame
through study completion, an average of 3 year
Title
Overall survial (OS)
Time Frame
through study completion, an average of 5 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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:
Bilirubin <1.5 times the upper limit of normal (ULN)
ALT , AST and APL≤2.5 × ULN
NEUT≥2.0 × 10^9 / L
PLT ≥ 100 × 10^9 / L
HB≥60g/L
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Lei, M.D
Phone
+86 023-68757176
Email
dpxinlei@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xin Lei, M.D
Organizational Affiliation
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
City
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Lei, M.D
12. IPD Sharing Statement
Learn more about this trial
Pelvic External Combined With 252-Cf Neutron Intracavitary Radiotherapy With or Without Platinum in Treating Advanced Cervical Cancer
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