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Uterine Cervical NeoplasmsPhase 3POHIM-P3NCT06509724

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

A Phase 3 study testing Conventional Fractionated IMRT and Hypofractionated IMRT in people with Uterine Cervical Neoplasms, run by Samsung Medical Center at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 75 years, women only
Conditions the study is for
Uterine Cervical Neoplasms
What is being tested?
Conventional Fractionated IMRT and Hypofractionated IMRT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
248 participants
Where
1 siteSouth Korea
Study dates
19 Jul 2024to 31 Dec 2032
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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):
  • Pelvic lymph node metastasis B. Parametrial involvement C. Positive surgical margins
  • Adult aged 20 to 75 years
Show all 10Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Won Park, M.D.,Ph.D contact

+82-10-9933-2616

wonro.park@samsung.com

South Korea1 site, 1 recruiting

  • Samsung Medical Center

    Seoul, Gangnam-gu, 06351

    Won Park, M.D., Ph.D., +82-2-3410-2616, wonro.park@samsung.com

    Recruiting

Other trials in South Korea

About this study

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)

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.

Read the detailed description
  • 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.
Being tested
Conventional Fractionated IMRT, Hypofractionated IMRT
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional Fractionated IMRTRadiation

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

  • Hypofractionated IMRTRadiation

    • Dose: 2.5 Gy per session, total 16 sessions (40Gy)
    • Chemotherapy: Weekly, total 3 sessions
Study groups in NCT06509724
Study groupRoleWhat they receive
Conventional Fractionation GroupActive comparatorThe 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.
Receives: Radiation: Conventional Fractionated IMRT
Hypofractionation GroupExperimentalThe 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.
Receives: Radiation: Hypofractionated IMRT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 3 years

Secondary outcomes (5)

  1. 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.

    Measured: Up to 5 years

  2. 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.

    Measured: Up to 5 years

  3. 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.

    Measured: During treatment and up to 3 months post-treatment

  4. 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.

    Measured: From 3 months post-treatment up to 5 years

  5. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2024
  2. Study start19 Jul 2024
  3. Primary completion1 Jul 2027 (estimated)
  4. Study completion31 Dec 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
248 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06509724
Sponsor's protocol ID
SMC 2024-04-058
Other IDs
KROG 24-05
Acronym
POHIM-P3
Status last verified
Jul 2024
First submitted
9 Jul 2024
Last updated
26 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Cho WK, Park W, Lee JH, Kang HC, Yoon M, Eom KY, Kim YS, Park S, Kim YS, Kim YJ, Choi E, Kim DY. Postoperative conventional versus hypofractionated intensity-modulated radiation therapy with concurrent chemotherapy in cervical cancer: a prospective multicenter randomized phase III trial (POHIM_P3 trial). J Gynecol Oncol. 2026 Jan;37(1):e4. doi: 10.3802/jgo.2026.37.e4. Epub 2025 Jul 4.

    PubMed 40676909

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Conventional Fractionated IMRT and Hypofractionated IMRT in people with Uterine Cervical Neoplasms, run by Samsung Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Won Park, M.D.,Ph.D (+82-10-9933-2616, wonro.park@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Local control rate for the radiation treatment area (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06509724, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.

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