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NCT Number: NCT04974346

Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer

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.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paraaortic prophylactic irradiation and pelvic definitive concurrent chemoradiation

Radiation

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.

Pelvic definitive concurrent chemoradiation

Radiation

Pelvic definitive concurrent chemoradiation, including external beam radiotherapy, concurrent chemotherapy and brachytherapy.

Primary outcomes

  1. Progression-free survival rate

    Time frame: 3-year

    the percentage of participants in the group whose disease is likely to remain stable

Secondary outcomes

  1. Overall survival rate

    Time frame: 3-year

    the percentage of participants in the group who survives

  2. Para-aortic recurrence rate

    Time frame: 3-year

    the percentage of participants involved by recurrence in the area of para-aortic lymph node

  3. 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

  4. Side effects

    Time frame: 3-year

    side effects associated with treatment

  5. 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 )

  6. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Zhejiang Cancer Hospital

Other

Registry information

Official study title

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

Acronym: PAILACC

Important dates

Study start
2021
Primary completion
2028
Study completion
2030
First posted
Jul 23, 2021
Registry last updated
Jan 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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