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

Primary Purpose

Cervical Cancer

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Paraaortic prophylactic irradiation and pelvic definitive concurrent chemoradiation
Pelvic definitive concurrent chemoradiation
Sponsored by
Zhejiang Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring locally advanced cervical cancer, para-aortic radiotherapy, concurrent radiochemotherapy, PET-CT

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Zhejiang Cancer HospitalRecruiting
  • The First Affiliated Hospital, Zhejiang University School of Medicine
  • Jinhua Municipal Central Hospital Medical Group
  • Lishui People's Hospital
  • Ningbo First Hospital
  • Taizhou Central Hospiatl
  • Chongqing University Three Gorges Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

study arm

control arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Progression-free survival rate
the percentage of participants in the group whose disease is likely to remain stable

Secondary Outcome Measures

Overall survival rate
the percentage of participants in the group who survives
Para-aortic recurrence rate
the percentage of participants involved by recurrence in the area of para-aortic lymph node
Distant recurrence rate
the percentage of participants involved by recurrence in any organ or tissue except pelvic and para-aortic area
Side effects
side effects associated with treatment
Quality of life (QOL) assessed by EORTC QLQ-C30 v3
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 )
Quality of life (QOL) assessed by EORTC QLQ-CX24
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)

Full Information

First Posted
July 4, 2021
Last Updated
January 24, 2022
Sponsor
Zhejiang Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04974346
Brief Title
Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer
Acronym
PAILACC
Official Title
Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer: a Prospective, Randomized, Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 2, 2021 (Actual)
Primary Completion Date
August 1, 2028 (Anticipated)
Study Completion Date
August 1, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
locally advanced cervical cancer, para-aortic radiotherapy, concurrent radiochemotherapy, PET-CT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
455 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study arm
Arm Type
Experimental
Arm Description
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.
Arm Title
control arm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Paraaortic prophylactic irradiation and pelvic definitive concurrent chemoradiation
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Pelvic definitive concurrent chemoradiation
Intervention Description
Pelvic definitive concurrent chemoradiation, including external beam radiotherapy, concurrent chemotherapy and brachytherapy.
Primary Outcome Measure Information:
Title
Progression-free survival rate
Description
the percentage of participants in the group whose disease is likely to remain stable
Time Frame
3-year
Secondary Outcome Measure Information:
Title
Overall survival rate
Description
the percentage of participants in the group who survives
Time Frame
3-year
Title
Para-aortic recurrence rate
Description
the percentage of participants involved by recurrence in the area of para-aortic lymph node
Time Frame
3-year
Title
Distant recurrence rate
Description
the percentage of participants involved by recurrence in any organ or tissue except pelvic and para-aortic area
Time Frame
3-years
Title
Side effects
Description
side effects associated with treatment
Time Frame
3-year
Title
Quality of life (QOL) assessed by EORTC QLQ-C30 v3
Description
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 )
Time Frame
1-month and 6-month
Title
Quality of life (QOL) assessed by EORTC QLQ-CX24
Description
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)
Time Frame
1-month and 6-month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiang Zhang
Phone
0086-571-88122148
Email
zhangxiang@zjcc.org.cn
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiang Zhang
Phone
0086-571-88122048
Email
zhangxiang@zjcc.org.cn
First Name & Middle Initial & Last Name & Degree
Xiang Zhang
First Name & Middle Initial & Last Name & Degree
Jianhong Chen
First Name & Middle Initial & Last Name & Degree
Yeqiang Tu
Facility Name
The First Affiliated Hospital, Zhejiang University School of Medicine
City
Hangzhou
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Jinhua Municipal Central Hospital Medical Group
City
Jinhua
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Lishui People's Hospital
City
Lishui
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Ningbo First Hospital
City
Ningbo
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Taizhou Central Hospiatl
City
Taizhou
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Chongqing University Three Gorges Hospital
City
Wanzhou
Country
China
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer

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