NCT03955367

Brief Summary

To investigate the value of prophylactic extended-field irradiation (EFI), we conduct a randomized clinical trial to compare the efficacy and toxicity of pelvic irradiation and prophylactic EFI in selected patients with cervical cancer treated with definitive concurrent chemoradiotherapy. External beam radiation therapy is delivered with intensity-modulated radiation therapy (IMRT).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
638

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2019

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 20, 2019

Completed
28 days until next milestone

Study Start

First participant enrolled

June 17, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

February 23, 2022

Status Verified

February 1, 2022

Enrollment Period

3 years

First QC Date

May 11, 2019

Last Update Submit

February 6, 2022

Conditions

Uterine Cervical Neoplasms

Keywords

Uterine Cervical NeoplasmsExtended-field irradiation

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    Progression-free survival is defined as the time from randomization to disease progression or death from any cause, whichever is first.

    3-year

Secondary Outcomes (5)

  • Overall survival

    3-year

  • Distant failure-free survival

    3-year

  • Para-aortic lymph nodes failure rate

    3-year

  • Acute toxicity evaluated with CTCAE 5.0

    From the start of treatment to 3 months after treatment.

  • Late toxicity evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme

    3-year

Study Arms (2)

Pelvic Irradiation

ACTIVE COMPARATOR

Patients receive concurrent chemoradiotherapy. The CTV includes the gross tumor, cervix, uterus, parametrium, upper part of the vagina, and pelvic lymph nodes regions. The upper border of CTV is at the level of aortic bifurcation. A dose of 45-50.4Gy is delivered to CTV with IMRT.

Radiation: Pelvic irradiationRadiation: Intracavitary brachytherapyDrug: Concurrent chemotherapy

Prophylactic EFI

EXPERIMENTAL

Patients receive concurrent chemoradiotherapy. The CTV includes the gross tumor, cervix, uterus, parametrium, upper part of the vagina, pelvic lymph nodes regions and para-aortic lymph nodes region. The upper border of CTV is at the level of renal vessels. A dose of 45-50.4Gy is delivered to CTV with IMRT.

Radiation: Prophylactic extended-field IrradiationRadiation: Intracavitary brachytherapyDrug: Concurrent chemotherapy

Interventions

Prophylactic extended-field IrradiationRADIATION

CTV covers pelvis and para-aortic lymph nodes region.

Also known as: Prophylactic radiotherapy for para-aortic lymph nodes region
Prophylactic EFI
Pelvic irradiationRADIATION

CTV covers pelvis.

Also known as: Pelvic radiotherapy
Pelvic Irradiation
Intracavitary brachytherapyRADIATION

The total dose delivered to point A or high-risk CTV is ≥80Gy. For patients with larger-volume cervical tumor, the total dose is ≥85Gy.

Also known as: Brachytherapy
Pelvic IrradiationProphylactic EFI
Concurrent chemotherapyDRUG

Cisplatin based concurrent chemotherapy, including cisplatin as a single agent or cisplatin plus Paclitaxel.

Also known as: Chemotherapy
Pelvic IrradiationProphylactic EFI

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must be informed of the investigational nature of this study and give written informed consent with 30 days before treatment.
  • Age ≥18 years and ≤ 70 years.
  • Patients with newly histologically confirmed cervical cancer, including squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma, et al.
  • No evidence of para-aortic metastatic lymph nodes (MLNs) on CT, MRI or positron emission tomograph (PET)/CT.\*
  • No evidence of distant metastasis (FIGO stage IVB).
  • At least meet one of the following characteristics:
  • Number of pelvic MLNs ≥ 2;
  • Short diameter of pelvic MLNs ≥ 1.5cm; \*
  • Parametrial involvement to the pelvic wall ＃.
  • Satisfactory performance: Eastern Cooperative Oncology Group (ECOG) score ≥ 2.
  • Adequate marrow: neutrophile granulocyte count ≥1.5\*10\^9/L, hemoglobin ≥ 80 g/L, platelet count ≥100\*10\^9/L.
  • Normal liver and kidney function: Creatinine (Cr) \< 1.5 mg/dl, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) \< 2\*upper limit of normal (ULN).
  • MLNs refer to positive lymph nodes confirmed by PET/CT or lymph nodes with short diameter ≥ 1 cm on CT or MRI.
  • Parametrial involvement to the pelvic wall is diagnosed with gynecological examination or MRI;

You may not qualify if:

  • With common iliac MLNs.
  • Tumor extended to the lower third of the vagina.
  • Tumor spread to mucosa of the bladder or rectum.
  • Prior surgery (including pelvic or para-aortic lymph nodes resection, except for tumor biopsy), radiotherapy or chemotherapy to primary tumor or nodes.
  • Prior malignancy.
  • History of previous radiotherapy to the abdomen or pelvis.
  • Pregnancy or lactation.
  • Active inflammatory bowel disease, or history of severe stomach or duodenal ulcer.
  • Active infection with fever.
  • Patients with unacceptable risk that intracavitary brachytherapy can not be conducted.
  • Any severe disease which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control, and emotional disturbance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

First Affiliated Hospital Xi'an Jiaotong University

Xi’an, Shanxi, China

RECRUITING

Related Publications (1)

  • Wang W, Liu X, Meng Q, Zhang F, Hu K. Prophylactic Extended-Field Irradiation for Patients With Cervical Cancer Treated With Concurrent Chemoradiotherapy: A Propensity-Score Matching Analysis. Int J Gynecol Cancer. 2018 Oct;28(8):1584-1591. doi: 10.1097/IGC.0000000000001344.

    PMID: 30153215BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

BrachytherapyDrug Therapy

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeutics

Study Officials

  • Ke Hu

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ke Hu

CONTACT

+86-01069155487huk@pumch.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice director of Radiation Oncology Department

Study Record Dates

First Submitted

May 11, 2019

First Posted

May 20, 2019

Study Start

June 17, 2019

Primary Completion

June 1, 2022

Study Completion

June 1, 2025

Last Updated

February 23, 2022

Record last verified: 2022-02

Locations

CN(2)