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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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