Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer

NCT04974346 | Recruiting Phase 3

• 1 other identifier: CARTOnG 2101
• Study Type: interventional
• Target: 455
• Locations: 1 country
• Sites: 7

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.

Conditions

Cervical Cancer

Keywords

locally advanced cervical cancer; para-aortic radiotherapy; concurrent radiochemotherapy; PET-CT

Outcome Measures

Primary Outcomes (1)

• Progression-free survival rate

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

  3-year

Secondary Outcomes (6)

• Overall survival rate

  3-year

• Para-aortic recurrence rate

  3-year

• Distant recurrence rate

  3-years

• Side effects

  3-year

• Quality of life (QOL) assessed by EORTC QLQ-C30 v3

  1-month and 6-month

Study Arms (2)

study arm

EXPERIMENTAL

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

control arm

ACTIVE COMPARATOR

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

Interventions

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.

study arm

Pelvic definitive concurrent chemoradiation RADIATION

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

control arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients voluntarily participated in the study and signed the informed consent
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (7)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China

ACTIVE NOT RECRUITING

Jinhua Municipal Central Hospital Medical Group

Jinhua, China

ACTIVE NOT RECRUITING

Lishui People's Hospital

Lishui, China

ACTIVE NOT RECRUITING

Ningbo First Hospital

Ningbo, China

ACTIVE NOT RECRUITING

Taizhou Central Hospiatl

Taizhou, China

ACTIVE NOT RECRUITING

Chongqing University Three Gorges Hospital

Wanzhou, China

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Xiang Zhang

CONTACT

0086-571-88122148; zhangxiang@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2021
• First Posted: July 23, 2021
• Study Start: August 2, 2021
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2030
• Last Updated: January 25, 2022

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)