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Adjuvant Moderately Hypofractionated Intensity-modulated Radiotherapy for Cervical Cancer

ConditionsHypofractionated RadiotherapyIntensity-modulated RadiotherapyCervical Cancers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorManni Huang

About this trial

To investigate the safety and efficacy of moderately hypofractionated intensity-modulated radiotherapy in the treatment of postoperative cervical cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ECOG performance status 0 or 1;

Histologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma;

Status post radical hysterectomy with pelvic lymph node dissection with or without para-aortic lymph node dissection, and postoperative radiotherapy initiated within 3 months;

For squamous cell carcinoma: meeting Sedlis criteria; for adenocarcinoma and adenosquamous carcinoma: meeting the "four-factor model";

Disqualifiers

History of active malignant tumor within 3 years prior to initial treatment（except for the cervical cancer）and any locally curable tumors treated with radical therapy;

Any high-risk factor confirmed by postoperative pathology: positive lymph node metastasis, positive parametrial invasion, or positive resection margin;

History of neoadjuvant therapy prior to enrollment;

Local recurrence or distant metastasis prior to enrollment;

Trial design

Design model

Single group

Treatments tested in this trial

  • Postoperative Radiotherapy

    Radiation

    Postoperative moderately hypofractionated IMRT (2.5Gy per fraction, 17 fractions, once a day)

Treatment groups

154 Participants
are divided into 1 treatment group
Group A: Postoperative RadiotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Acute toxicities

the incidence of acute grade 3 or higher gastrointestinal (GI), genitourinary (GU), and hematologic toxicities during radiotherapy (RT) or within three months after RT completion, based on the CTCAE version 6.0

Time frame
3 months

Secondary outcomes

1

Late toxicities

evaluation of late toxicities during three months to one year after RT completion according to CTCAE version 6.0

Time frame
1 year
2

Disease-Free Survival (DFS)

the time from initiation of study treatment to the first occurrence of locoregional recurrence, distant metastasis, or death from any cause.

Time frame
2-years
3

Overall Survival (OS)

the time from the start of study treatment to death from any cause.

Time frame
2-years
4

Patient-reported quality of life

scores of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) / Cervical Cancer Module (EORTC QLQ-CX24).The scale ranges from 0 to 100, where higher scores represent better quality of life.

Time frame
2-years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Manni Huang

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Sponsor institution

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Collaborator

Source ClinicalTrials.gov
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