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

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: Recruiting
• Conditions: Cervical Cancer
• Intervention / Treatment: Radiation: Paraaortic prophylactic irradiation and pelvic definitive concurrent chemoradiation; Radiation: Pelvic definitive concurrent chemoradiation

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: Interventional
• Enrollment (Anticipated): 455
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Xiang Zhang; Phone Number: 0086-571-88122148; Email: zhangxiang@zjcc.org.cn

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: Xiang Zhang; Phone Number: 0086-571-88122048; Email: zhangxiang@zjcc.org.cn
      • Sub-Investigator: Jianhong Chen
      • Sub-Investigator: Yeqiang Tu

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Progression-free survival rate	the percentage of participants in the group whose disease is likely to remain stable	3-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival rate	the percentage of participants in the group who survives	3-year
Para-aortic recurrence rate	the percentage of participants involved by recurrence in the area of para-aortic lymph node	3-year
Distant recurrence rate	the percentage of participants involved by recurrence in any organ or tissue except pelvic and para-aortic area	3-years
Side effects	side effects associated with treatment	3-year
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 )	1-month and 6-month
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)	1-month and 6-month

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2021
• Primary Completion (Anticipated): August 1, 2028
• Study Completion (Anticipated): August 1, 2030

Study Registration Dates

• First Submitted: July 4, 2021
• First Submitted That Met QC Criteria: July 22, 2021
• First Posted (Actual): July 23, 2021

Study Record Updates

• Last Update Posted (Actual): January 25, 2022
• Last Update Submitted That Met QC Criteria: January 24, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: concurrent radiochemotherapy; PET-CT; locally advanced cervical cancer; para-aortic radiotherapy
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID 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