NCT04831437

Brief Summary

Uterine cervix cancer can be treated definitively with concurrent chemoradiation (external beam radiotherapy and chemotherapy) followed by high dose rate brachytherapy. Treatment duration can be shortened by increasing the dose per fraction of treatment which can reduce costs and patient exposure. The aim of our study is to determine the non-inferiority of hypofractionated radiotherapy compared with conventional treatment.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
22mo left

Started Apr 2021

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress74%
Apr 2021Mar 2028

Study Start

First participant enrolled

April 1, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Expected
Last Updated

October 12, 2021

Status Verified

March 1, 2021

Enrollment Period

1.9 years

First QC Date

April 2, 2021

Last Update Submit

October 11, 2021

Conditions

Cervix Uteri Cancer

Keywords

HypofractionationChemoradiationBrachytherapy

Outcome Measures

Primary Outcomes (2)

  • Early toxicity

    Early treatment-related toxicity within 3 months after completion of treatment as defined by CTCAE 5.0.

    3 months after completion of treatment

  • Early response

    Early response to treatment at 3 months after treatment completion based on dynamic contrast-enhanced pelvic MRI findings

    3 months after completion of treatment

Secondary Outcomes (4)

  • Late toxicity

    1 and 3 years after completion of treatment

  • Progression-free survival

    5 years

  • Disease-specific survival

    5 years

  • Overall survival

    5 years

Study Arms (2)

Hypofractionated

EXPERIMENTAL

EBRT 40Gy/15fr

Radiation: Hypofractionated EBRT

Control Group

ACTIVE COMPARATOR

EBRT 45Gy/ 25fr

Radiation: Standard EBRT

Interventions

Hypofractionated EBRTRADIATION

EBRT dose of 40Gy in 15 fractions over 3 weeks plus 3 weekly infusions of cisplatin 40mg/m2

Hypofractionated
Standard EBRTRADIATION

EBRT dose of 45Gy in 25 fractions over 5 weeks plus 5 weekly infusions of cisplatin 40mg/m2

Control Group

Eligibility Criteria

Age18 Years - 85 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathology of squamous cell carcinoma (SCC), adenocarcinoma, adenosquamous carcinoma of uterine cervix- International Federation of Gynecology and Obstetrics (FIGO) stage IB, IIA, IIB, IIIA, IIIB (due to hydronephrosis without creatinine clearance compromise), IIIC1 (if less than 3 lymph nodes with size less than 3cm, and without involvement of common iliac chain)- Patient eligible for definitive chemoradiotherapy followed by brachytherapy

You may not qualify if:

  • Creatinine clearance less than 30ml/min, any histology other than the above, requirement of paraaortic lymph node irradiation, inflammatory bowel disease, connective tissue disorders, previous pelvic radiotherapy, FIGO stage IA or IV, Eastern Cooperative Oncology Group (ECOG) performance status greater than 2, History of previous hysterectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imam Khomeini Hospital Complex

Tehran, 1419733141, Iran

RECRUITING

Related Publications (1)

  • Maddah Safaei A, Esmati E, Gomar M, Akhavan S, Sheikh Hasani S, Malekzadeh Moghani M, Zamani N, Moshtaghi M, Malek M, Jafari F, Sharifian A, Kolahdouzan K. Hypofractionated versus standard chemoradiotherapy in the definitive treatment of uterine cervix cancer: interim results of a randomized controlled clinical trial. J Cancer Res Clin Oncol. 2024 Jan 20;150(1):20. doi: 10.1007/s00432-023-05563-8.

    PMID: 38244105DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Afsaneh Maddah-Safaei, M.D.

    Tehran University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kasra Kolahdouzan, M.D.

CONTACT

+989144083785k-kolahdouzan@razi.tums.ac.ir

Ebrahim Esmati, M.D.

CONTACT

+989126880306eb_esmati@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2021

First Posted

April 5, 2021

Study Start

April 1, 2021

Primary Completion

March 1, 2023

Study Completion (Estimated)

March 1, 2028

Last Updated

October 12, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)