NCT05277688

Brief Summary

To evaluate if adjuvant concurrent chemoradiotherapy is associated with a recurrence-free survival benefit in comparison with radiotherapy alone in selected intermediate risk cervical cancer after radical surgery.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
340

participants targeted

Target at P50-P75 for phase_3

Timeline
20mo left

Started Mar 2022

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress72%
Mar 2022Dec 2027

First Submitted

Initial submission to the registry

March 2, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 14, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

March 15, 2022

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Expected
Last Updated

September 16, 2022

Status Verified

March 1, 2022

Enrollment Period

3.8 years

First QC Date

March 2, 2022

Last Update Submit

September 14, 2022

Conditions

Cervical Cancer

Keywords

cervical cancerearly stagechemoradiotherapyradiotherapysurvival

Outcome Measures

Primary Outcomes (1)

  • 5-year recurrence-free survival

    From date of surgery until the date of first documented local-regional progression or distant metastasis (determined by CT or MRI scan and/or biopsy) or death (from any cause) assessed up to five years.

    5 years

Secondary Outcomes (3)

  • 5-year overall survival

    5 years

  • Acute toxicity

    3 months

  • Quality of Life (QoL)

    2 years

Study Arms (2)

experimental group

EXPERIMENTAL

concurrent chemotherapy: cisplatin（DDP） weekly, 40mg/m2, begin with radiation Drug: cisplatin（DDP） weekly; pelvic radiotherapy: intensity modulated radiotherapy (IMRT) is given five fractions per week at 1.8-2 Gy/fraction/day with total dose summed up to 45-50Gy.

Drug: adjuvant concurrent chemoradiotherapy

controlled group

ACTIVE COMPARATOR

pelvic radiotherapy alone: intensity modulated radiotherapy (IMRT) is given five fractions per week at 1.8-2 Gy/fraction/day with total dose summed up to 45-50Gy.

Radiation: radiotherapy

Interventions

adjuvant concurrent chemoradiotherapyDRUG

concurrent chemotherapy: cisplatin（DDP） weekly, 40mg/m2, begin with radiation Drug: cisplatin（DDP） weekly; Intensity modulated radiotherapy (IMRT) is given five fractions per week at 1.8-2 Gy/fraction/day with total dose summed up to 45-50Gy.

experimental group
radiotherapyRADIATION

Intensity modulated radiotherapy (IMRT) is given five fractions per week at 1.8-2 Gy/fraction/day with total dose summed up to 45-50Gy.

controlled group

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailscervical cancer is only found and diagnosed in female patients
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 18 Years to 80 Years
  • Histologically proven cervical cancer, FIGO stage Ia2-IIb,and no previous chemotherapy and radiotherapy
  • Accepted radical hysterectomy 3-4 weeks before
  • Karnofsky score \>70
  • Postoperative pathology with one of the three risk factors criterials: (1) lympho-vascular space invasion(LVSI+) and deep 1/3 stromal invasion; (2 ) LVSI(+) and middle 1/3 stromal invasion, and tumor size≥4cm (3)Non-squamous cell carcinoma;
  • Examination results showed no radiation or chemotherapy contraindication
  • Willing to accept treatment
  • Ability to comply with trial requirements

You may not qualify if:

  • Postoperative residual
  • Postoperative recurrence or metastasis
  • Pelvic lymph node metastasis
  • parametrial invasion
  • positive surgical margin
  • Without lymph node dissection
  • Postoperative pathology showed aortic lymph node metastasis
  • Examination results showed radiotherapy contraindications
  • No indications for radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ruijin Hospital, Shanghai jiaotong univestigy school of medicine

Shanghai, Shanghai Municipality, 200025, China

NOT YET RECRUITING

Ruijin Hospital, Shanghai jiaotong univestigy school of medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Radiotherapy

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)

Therapeutics

Central Study Contacts

Wei-Xiang Qi, Dr.

CONTACT

+862164370045qiweixiang1113@163.com

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

March 2, 2022

First Posted

March 14, 2022

Study Start

March 15, 2022

Primary Completion

December 30, 2025

Study Completion (Estimated)

December 30, 2027

Last Updated

September 16, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

we donot plan to share the IPD data about the trial

Locations

CN(2)