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Postoperative Hypofractionated Whole Pelvic Radiotherapy in Cervical and Endometrial Cancer (PostOP HYPOCxE)

2026년 5월 12일 업데이트: Wiwatchai Sittiwong, Siriraj Hospital

PostOPerative HYPOfractionated Whole Pelvic Radiotherapy in Cervical (Cx) and Endometrial Cancer (PostOP HYPOCxE Trial) : A Phase II Non-inferiority Randomized Controlled Trial

This study aims to evaluate a shorter course of postoperative pelvic radiotherapy in patients with cervical and endometrial cancer. The standard radiotherapy schedule usually requires many treatment sessions over several weeks, which can be burdensome for patients and may affect their ability to complete treatment.

This study will compare a shorter radiotherapy schedule (hypofractionated radiotherapy) with the standard schedule. Both treatments deliver a similar total radiation dose, but the shorter schedule reduces the number of hospital visits and overall treatment time.

Participants will be randomly assigned to receive either the shorter or standard radiotherapy after surgery. The study will evaluate side effects, treatment effectiveness, and quality of life. The goal is to determine whether the shorter treatment is as safe and effective as the standard approach.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

Cervical cancer remains a major health problem, particularly in low- and middle-income countries. Standard postoperative pelvic radiotherapy requires multiple treatment sessions over several weeks, which may limit patient access, increase treatment burden, and prolong overall treatment time. Prolonged treatment duration has been associated with reduced tumor control, and frequent hospital visits may also increase risks for patients, especially during infectious disease outbreaks.

Hypofractionated radiotherapy delivers a higher dose per fraction while maintaining a similar total radiation dose, allowing for a shorter overall treatment course. This approach may improve treatment convenience, reduce healthcare resource utilization, and potentially enhance treatment outcomes without increasing toxicity. However, there is currently limited high-level evidence supporting its use in the postoperative setting for cervical and endometrial cancer.

This study is a phase II randomized controlled trial designed to evaluate the safety and efficacy of postoperative hypofractionated whole pelvic radiotherapy compared with conventional radiotherapy in patients with cervical and endometrial cancer. Participants will be randomly assigned to receive either hypofractionated or standard radiotherapy following surgery.

The study will assess treatment-related toxicity, tumor response, survival outcomes, and quality of life. The results of this study may help establish whether a shorter radiotherapy schedule can be safely implemented as an alternative to standard treatment.

연구 유형

중재적

등록 (추정된)

120

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 태국
    • Bangkok
      • Bangkok, Bangkok, 태국
        • 모병
        • Siriraj Hospital
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  1. Pathologically proven carcinoma of the uterine cervix; and carcinoma and carcinosarcoma of uterine corpus
  2. Hysterectomy (total abdominal hysterectomy, vaginal hysterectomy, total laparoscopic hysterectomy or radical hysterectomy) for cancer of the cervix or endometrium within 49 days prior to registration. Hence inadvertent surgery will be allowed for inclusion.
  3. Indicated for adjuvant EBRT from multidisciplinary team discussion.
  4. Non-metastatic stage according to FIGO 2018 for Cervical cancer and FIGO 2023 for Endometrial cancer and TNM guidelines from appropriate diagnostic workup 4.1 History/physical examination within 45 days prior to registration 4.2 CT/MRI/PET-CT of abdomen/pelvis demonstrating the absence of distant metastasis, performed pre- or post-surgery within 90 days prior to registration 4.3 Chest x-ray or chest CT (or a PET/CT) performed within 90 days prior to registration
  5. Age ≥18 years old with informed consent

Exclusion Criteria:

  1. Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin
  2. Small cell neuroendocrine cancer, melanoma, uterine sarcoma, and other rare cancers in the cervix and uterus
  3. Metastatic disease beyond intervertebral disc L2/3 level
  4. Previous pelvic or abdominal radiotherapy
  5. Combination of preoperative chemotherapy or radiotherapy with surgery
  6. Contra-indications to EBRT

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: CVRT
Participants receive standard postoperative whole pelvic radiotherapy.
방사능: Conventional Radiotherapy
Standard postoperative whole pelvic radiotherapy delivered using conventional fractionation with a lower dose per fraction over a greater number of treatment sessions.
실험적: HYPO
Participants receive postoperative hypofractionated whole pelvic radiotherapy.
방사능: Hypofractionated Radiotherapy
Postoperative hypofractionated whole pelvic radiotherapy delivered with a higher dose per fraction and a reduced number of treatment sessions compared to conventional radiotherapy, while maintaining a similar total radiation dose.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Incidence of Acute Treatment-Related Toxicity
기간: During treatment and up to 3 months after completion of radiotherapy
The incidence of acute treatment-related toxicity during radiotherapy and at 1- and 3-month follow-up, assessed using CTCAE version 5.0.
During treatment and up to 3 months after completion of radiotherapy
Incidence of Late Treatment-Related Toxicity
기간: From 6 months up to 5 years after completion of radiotherapy
The incidence of late (chronic) treatment-related toxicity assessed at 6 and 12 months, and at 3 and 5 years after treatment, using CTCAE version 5.0.
From 6 months up to 5 years after completion of radiotherapy

2차 결과 측정

결과 측정
측정값 설명
기간
Tumor Response Rate
기간: Up to 12 months after completion of radiotherapy
Tumor response rate following external beam radiotherapy, assessed during the post-treatment period and at 3-, 6-, and 12-month follow-up.
Up to 12 months after completion of radiotherapy
Quality of Life Assessed by EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)
기간: From baseline up to 5 years after completion of radiotherapy
Patient-reported quality of life assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) during treatment and at 1-, 3-, 6-, and 12-month, and 3- and 5-year follow-up. The EQ-5D-5L descriptive system evaluates mobility, self-care, usual activities, pain/discomfort, and anxiety/depression across 5 levels of severity. The EQ Visual Analog Scale (EQ-VAS) ranges from 0 to 100, with higher scores indicating better perceived health status.
From baseline up to 5 years after completion of radiotherapy
Local and Nodal Recurrence-Free Survival
기간: Up to 5 years after completion of radiotherapy
Time from treatment completion to local or nodal disease recurrence.
Up to 5 years after completion of radiotherapy
Distant Metastasis-Free Survival
기간: Up to 5 years after completion of radiotherapy
Time from treatment completion to distant metastasis
Up to 5 years after completion of radiotherapy
Overall Survival
기간: Up to 5 years after completion of radiotherapy.
Time from completion of radiotherapy to death from any cause.
Up to 5 years after completion of radiotherapy.
Incremental Cost-effectiveness Ratio per Quality-adjusted Life Year Between Hypofractionated and Conventional Radiotherapy
기간: During treatment and follow-up up to 5 years after completion of radiotherapy.
Cost and utility data will be used to evaluate cost-effectiveness by calculating the incremental cost-effectiveness ratio (ICER) between hypofractionated and conventional radiotherapy. Uncertainty analyses will be performed using one-way sensitivity analysis, probabilistic sensitivity analysis, and threshold analysis.
During treatment and follow-up up to 5 years after completion of radiotherapy.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Siriraj Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 3월 11일

기본 완료 (추정된)

2026년 12월 31일

연구 완료 (추정된)

2028년 12월 31일

연구 등록 날짜

최초 제출

2026년 4월 16일

QC 기준을 충족하는 최초 제출

2026년 5월 12일

처음 게시됨 (실제)

2026년 5월 19일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 19일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 12일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • Si 739/2567(IRB4)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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