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

NCT06509724RecruitingPHASE3INTERVENTIONAL

Summary

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.

Key Facts

Lead Sponsor

Samsung Medical Center

Enrollment

248

Start Date

2024-07-19

Completion Date

2027-07-01

Study Type

INTERVENTIONAL

Official Title

Postoperative Conventional Versus Hypofractionated Intensity-modulated Radiation Therapy With Concurrent Chemotherapy in Cervical Cancer: A Prospective Multicenter Randomized Phase III Trial (POHIM_P3 Trial)

Interventions

Conventional Fractionated IMRTHypofractionated IMRT

Conditions

Uterine Cervical Neoplasms

Eligibility

Age Range

20 Years – 75 Years

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Local control rate for the radiation treatment area

The percentage of patients who achieve local control of their cervical cancer within the radiation treatment area. Local control is defined as the absence of tumor recurrence or progression in the region.

Time frame: Up to 3 years

Secondary Outcomes

Overall survival (OS)

The duration of time from the date of randomization until death from any cause. This measure will evaluate the effectiveness of the treatment in prolonging life.

Time frame: Up to 5 years

Disease-free survival (DFS)

The length of time from the date of randomization until the occurrence of any signs or symptoms of cervical cancer, such as local recurrence, distant metastasis, or secondary cancer. This measure assesses the efficacy of the treatment in preventing cancer recurrence.

Time frame: Up to 5 years

Acute Toxicity Profile

The incidence and severity of acute treatment-related toxicities, as measured by the Common Terminology Criteria for Adverse Events (CTCAE). Acute toxicities are those occurring within 90days of the start of treatment.

Time frame: During treatment and up to 3 months post-treatment

Late Toxicity Profile

The incidence and severity of late treatment-related toxicities, as measured by the Common Terminology Criteria for Adverse Events (CTCAE). Late toxicities are those occurring more than 90 days after the completion of treatment.

Time frame: From 3 months post-treatment up to 5 years

Quality of life (QoL)

Assessment of the patients' quality of life using validated questionnaires such as the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). This measure evaluates the impact of treatment on the patients' overall well-being.

Time frame: Baseline, end of treatment, 6 months post-treatment, and annually up to 5 years

Locations

Samsung Medical Center, Seoul, South Korea

Linked Diseases

Uterine Cervical Neoplasms

Uterine Cervical Neoplasms — a type of gynecological cancer.

Linked Papers

2025-07-04

Postoperative conventional versus hypofractionated intensity-modulated radiation therapy with concurrent chemotherapy in cervical cancer: a prospective multicenter randomized phase III trial (POHIM_P3 trial)

For patients with high-risk factors such as pelvic lymph node metastasis, positive surgical margins, or parametrial involvement, concurrent chemoradiotherapy (CCRT) with whole-pelvic radiotherapy significantly improves survival outcomes. Hypofractionated radiation therapy, which delivers higher radiation doses over fewer sessions, enhances tumor control but raises concerns about increased normal tissue toxicity. A recent Korean phase II study (POHIM-CCRT) evaluated the safety of hypofractionated intensity-modulated radiation therapy (IMRT), delivering 40 Gy in 16 fractions with weekly cisplatin following radical surgery. The results showed minimal acute toxicity. Based on these findings, the present study was designed to assess the oncologic efficacy of hypofractionated CCRT compared to conventional treatment strategies in high-risk cervical cancer patients after radical surgery. The POHIM-P3 trial is a phase 3, randomized, multicenter study designed for women with cervical cancer requiring adjuvant CCRT after radical hysterectomy. Participants in the experimental arm receive hypofractionated IMRT to whole pelvis, delivering a total dose of 40 Gy in 16 fractions, and the control arm receive conventional radiotherapy with a total dose of 45-50.4 Gy in 25-28 fractions in combination with weekly cisplatin. The primary endpoint of the study is the 3-year disease-free survival and the secondary endpoints included acute and late side-effects, local control rates, and overall survival rates. ClinicalTrials.gov Identifier: NCT06509724.

Linked Investigators

Dong-Yun Kim

Euncheol Choi

Hyun-Cheol Kang

Jong Hoon Lee

Keun-Yong Eom

Meesun Yoon

Sangjoon Park

Won Kyung Cho

Won Park

Yeon Joo Kim

Yeon‐Sil Kim

Young Seok Kim