Comparison of Conventional and Hypofractionated IMRT in High-Risk Cervical Cancer Post-Radical Hysterectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

248 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-19

Study Completion Date

2032-12-31

Brief Summary

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Radical hysterectomy and radiation therapy are standard treatments for cervical cancer. However, there are no reported studies on the frequency of side effects and treatment outcomes when hypofractionated radiation therapy and intensity modulated radiation therapy(IMRT) are used during radiation therapy.

Hypofractionated radiation therapy increases the daily dose and reduces the number of treatment sessions, which may increase the risk of side effects, but its safety has been confirmed in some cases of early cervical cancer and endometrial cancer. Additionally, applying IMRT, a technique designed to protect normal tissue, during concurrent chemoradiotherapy has shown positive results in reducing the incidence of acute side effects.

Investigators previously demonstrated that combining hypofractionated IMRT with chemotherapy for high-risk postoperative cervical cancer patients resulted in high survival rates and low toxicity in a phase 2 exploratory study. Base on this result, this study aimed to compare the efficacy and safety of conventional fractionated radiation therapy and hypofractionated radiation therapy.

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Detailed Description

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* This phase 3 multicenter randomized controlled trial evaluates two radiation therapy regiments in high-risk cervical cancer patients who have undergone radical hysterectomy. Participants are randomly assigned in a 1:1 ratio to receive either conventional fractionated IMRT(Intensity modulated radiation therapy) or hypo fractionated IMRT, both in combination with concurrent chemotherapy.
* The conventional fractionation group receives 1.8-2.0 Gy per session for a total of 25-28 sessions (total 40-50.4 Gy) with weekly chemotherapy (total 5-6 sessions). The hypofractionation group receives 2.5 Gy per session for a total of 16 sessions (total 40 Gy) with weekly chemotherapy (total 3 sessions). Brachytherapy is allowed in both group.
* Stratification factors for randomization include lymph node metastasis status and adenocarcinoma vs. non-adenocarcinoma. Blocked randomization will be used. The study aims to assess local control rates, overall, survival, disease-free survival, and acute and late toxicity profiles.

Conditions

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Uterine Cervical Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conventional Fractionation Group

The conventional fractionation group will receive 1.8-2.0G per session for a total of 25-28 sessions, amounting to 40-50.4Gy of radiation therapy. Chemotherapy will be administered once a week for a total of 5-6 sessions.

This group are allowed to receive brachytherapy.

Group Type ACTIVE_COMPARATOR

Conventional Fractionated IMRT

Intervention Type RADIATION

* Dose: 1.8-2.0 Gy per session, total 25-28 sessions (40-50.4Gy)
* Chemotherapy: Weekly, total 5-6 sessions

Hypofractionation Group

The hypofractionation group will receive 2.5Gy per session for a total of 16 sessions, amounting to 40 Gy of radiation therapy. Chemotherapy will be administered once a week for a total of 3 sessions.

This group are allowed to receive brachytherapy.

Group Type EXPERIMENTAL

Hypofractionated IMRT

Intervention Type RADIATION

* Dose: 2.5 Gy per session, total 16 sessions (40Gy)
* Chemotherapy: Weekly, total 3 sessions

Interventions

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Conventional Fractionated IMRT

* Dose: 1.8-2.0 Gy per session, total 25-28 sessions (40-50.4Gy)
* Chemotherapy: Weekly, total 5-6 sessions

Intervention Type RADIATION

Hypofractionated IMRT

* Dose: 2.5 Gy per session, total 16 sessions (40Gy)
* Chemotherapy: Weekly, total 3 sessions

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed histologically with cervical cancer
* Patients diagnosed histologically with Squamous cell carcinoma, Adenocarcinoma, or Adenosquamous carcinoma
* Patients who have undergone radical hysterectomy and pelvic lymphadenectomy
* Patients who meet the indication for radiotherapy in postoperative pathological examination (at least on of the following):

A. Pelvic lymph node metastasis B. Parametrial involvement C. Positive surgical margins

* Adult aged 20 to 75 years
* Patients with an ECOG 0-1 within 1 week prior to study participation
* Maintained bone marrow function: granulocyte ≥1.0 x 103/µl, platelets ≥30 x 103/µl, hemoglobin ≥9.5 g/dl
* Maintained renal and liver function (Creatinine \<2.0 mg/dL, Bilirubin \< 1.5 mg/dl)
* Patients who have voluntarily signed the consent form

Exclusion Criteria

* Patients with distance metastasis (including ovarian and para-aortic lymph node metastasis)
* Patients who have previously received radiotherapy to the pelvic area
* Patients who have undergone radical hysterectomy more than 3 months prior
* Patients with untreated serious acute illnesses (e.g., stroke, cerebral infarction, myocardial infarction) other than cervical cancer
* Patients who received neoadjuvant chemotherapy before surgery
* Patients who will not receive concurrent chemotherapy during radiotherapy
* Patients with a history of another cancer diagnosis within the past 5 years, except for thyroid cancer, skin cancer, or carcinoma in suit

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No