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

July 13, 2016 updated by: Xin Lei, M.D.Prof, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Chongqing, China
        • Recruiting
        • Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
        • Contact:
          • Xin Lei, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Concurrent radiochemotherapy Group
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
Drug: Nedaplatin
Chemotherapy: Nedaplatin(NDP) 30-40mg/m2 iv., on day1, 4weeks as one cycle
Other Names:
  • NDP
Radiation: Pelvic External Radiotherapy
patients received 20 Gy2.0/f, for 25-27f (SSD)with 8mv-X rays (SSD)
Radiation: 252-Cf Neutron Intracavitary Brachytherapy
total dose of reference point A was 4400cGy, in four times Transvaginal implant sessions during Pelvic External Radiations
Active Comparator: Radiotherapy Group
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.
Radiation: Pelvic External Radiotherapy
patients received 20 Gy2.0/f, for 25-27f (SSD)with 8mv-X rays (SSD)
Radiation: 252-Cf Neutron Intracavitary Brachytherapy
total dose of reference point A was 4400cGy, in four times Transvaginal implant sessions during Pelvic External Radiations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute toxicity events
Time Frame: 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
Week 5 of Radiation Therapy (RT)
Long-trem toxicity events
Time Frame: 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
through study completion, an average of 5 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Investigators

  • Principal Investigator: Xin Lei, M.D, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

November 1, 2018

Study Registration Dates

First Submitted

July 6, 2016

First Submitted That Met QC Criteria

July 13, 2016

First Posted (Estimate)

July 18, 2016

Study Record Updates

Last Update Posted (Estimate)

July 18, 2016

Last Update Submitted That Met QC Criteria

July 13, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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