Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer (PAILACC)

January 24, 2022 updated by: Zhejiang Cancer Hospital

Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer: a Prospective, Randomized, Multicenter Study

Para-aortic lymph node metastasis is a poor prognostic factor for locally advanced cervical cancer, but false negative diagnosis is easy to occur. The aim of this trial was to investigate whether para-aortic prophylactic radiotherapy improves disease-free survival in patients with positive pelvic lymph nodes below the common iliac artery.

Study Overview

Status

Status

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

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.

Detailed Description

This clinical trial enrolled participants with locally advanced cervical cancer with positive pelvic lymph nodes below the common iliac region diagnosed by Positron emission tomography-computed tomography(PET-CT). Participants should be able to receive concurrent cisplatin chemotherapy. No anti-tumor treatment was given before randomization. Participants will be randomly assigned to two groups. The study group will receive radiotherapy of pelvic and para-aorta, concurrent chemotherapy and brachytherapy, and the control group will receive pelvic radiotherapy, concurrent chemotherapy and brachytherapy.

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.
455

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 3

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
      • Hangzhou, China
        • Active, not recruiting
        • The First Affiliated Hospital, Zhejiang University School of Medicine
      • Jinhua, China
        • Active, not recruiting
        • Jinhua Municipal Central Hospital Medical Group
      • Lishui, China
        • Active, not recruiting
        • Lishui People's Hospital
      • Ningbo, China
        • Active, not recruiting
        • Ningbo First Hospital
      • Taizhou, China
        • Active, not recruiting
        • Taizhou Central Hospiatl
      • Wanzhou, China
        • Active, not recruiting
        • Chongqing University Three Gorges Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
        • Principal Investigator:
          • Xiang Zhang
        • Contact:
        • Sub-Investigator:
          • Jianhong Chen
        • Sub-Investigator:
          • Yeqiang Tu

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • The patients voluntarily participated in the study and signed the informed consent
  • 18-75 female
  • Cervical squamous cell carcinoma / adenocarcinoma / adenosquamous cell carcinoma
  • According to International Federation of Gynecology and Obstetrics(FIGO) 2009 stage, stage ⅠB2 - ⅣA with positive pelvic lymph nodes and negative common iliac and paraaortic lymph nodes diagnosed by PET-CT
  • Cisplatin chemotherapy is acceptable
  • Eastern Cooperative Oncology Group(ECOG) score 0-1
  • The expected survival was more than 6 months
  • Women of childbearing age must have a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and they are willing to use appropriate contraceptive methods during the test
  • According to the judgment of the researcher, those who can comply with the trial protocol

Exclusion Criteria:

  • Uncontrolled severe infection
  • Combined with other malignant tumor patients who need treatment and / or new diagnosis within 5 years
  • The patient has received anti-tumor treatment
  • Liver cirrhosis, decompensated liver disease, chronic renal insufficiency and renal failure
  • History of immunodeficiency, including HIV positive or other acquired congenital immunodeficiency disease
  • Myocardial infarction, severe arrhythmia and grade 2 or more congestive heart failure (NYHA classification)
  • Patients with previous pelvic artery embolization
  • Previous radiotherapy for pelvic malignant tumor
  • There was a history of severe allergic reaction to platinum containing chemotherapy drugs
  • Complications, need to be taken during the treatment of liver and kidney function damage drugs, such as tuberculosis
  • The patients who could not understand the content of the experiment and could not cooperate and refused to sign the informed consent
  • Patients with accompanying diseases or other special circumstances that seriously endanger the safety of patients or affect the completion of the study

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: study arm

External beam radiotherapy:

Pelvic and para-aortic radiotherapy 45-50.4Gy/25-28 fractions. PET-CT positive lymph node should be boost to a dose of 60Gy or higher. Parametrium(both) should be boost to a dose from 50Gy to 60Gy.

Concurrent chemotherapy:

Weekly cisplatin 40mg/m2 during external beam radiotherapy.

Brachytherapy:

High dose rate(HDR) Brachytherapy. The dose of high-risk clinical target volume(HR CTV) D90 or Point A should be 85Gy+/-10%. The dose of intermediate-risk clinical target volume(IR CTV) D98 should be 60Gy at least.
Radiation: Paraaortic prophylactic irradiation and pelvic definitive concurrent chemoradiation
The para-aortic area, from left renal vein level to abdominal aorta bifurcation level，will be prophylactic irradiation. The other intervention is the same as control arm.
Active Comparator: control arm

External beam radiotherapy:

Pelvic radiotherapy 45-50.4Gy/25-28 fractions. PET-CT positive lymph node should be boost to a dose of 60Gy or higher. Parametrium(both) should be boost to a dose from 50Gy to 60Gy.

Concurrent chemotherapy:

Weekly cisplatin 40mg/m2 during external beam radiotherapy.

Brachytherapy:

HDR Brachytherapy. The dose of HR CTV D90 or Point A should be 85Gy+/-10%. The dose of IR CTV D98 should be 60Gy at least.
Radiation: Pelvic definitive concurrent chemoradiation
Pelvic definitive concurrent chemoradiation, including external beam radiotherapy, concurrent chemotherapy and brachytherapy.

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
Progression-free survival rate
Time Frame: 3-year
the percentage of participants in the group whose disease is likely to remain stable
3-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
Overall survival rate
Time Frame: 3-year
the percentage of participants in the group who survives
3-year
Para-aortic recurrence rate
Time Frame: 3-year
the percentage of participants involved by recurrence in the area of para-aortic lymph node
3-year
Distant recurrence rate
Time Frame: 3-years
the percentage of participants involved by recurrence in any organ or tissue except pelvic and para-aortic area
3-years
Side effects
Time Frame: 3-year
side effects associated with treatment
3-year
Quality of life (QOL) assessed by EORTC QLQ-C30 v3
Time Frame: 1-month and 6-month
an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns (assessed by EORTC QLQ-C30 v3 )
1-month and 6-month
Quality of life (QOL) assessed by EORTC QLQ-CX24
Time Frame: 1-month and 6-month
an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns (assessed by EORTC QLQ-CX24)
1-month and 6-month

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.
Zhejiang Cancer Hospital

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 (Actual)

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.
August 2, 2021

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.
August 1, 2028

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.
August 1, 2030

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 4, 2021

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 22, 2021

First Posted (Actual)

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 23, 2021

Study Record Updates

Last Update Posted (Actual)

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.
January 25, 2022

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.
January 24, 2022

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.
July 1, 2021

More Information

Terms related to this study

Keywords

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.
  • CARTOnG 2101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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