Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06509724

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Uterine Cervical Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Diseases Uterine Neoplasms

Age range

20 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Samsung Medical Center

Seoul, Gangnam-gu, 06351, South Korea

Location status: Recruiting

Location contact

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

CONTACT

[email protected]

+82-2-3410-2616

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional Fractionated IMRT

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

Hypofractionated IMRT

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

Primary outcomes

  1. Local control rate for the radiation treatment area

    Time frame: Up to 3 years

    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.

Secondary outcomes

  1. Overall survival (OS)

    Time frame: Up to 5 years

    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.

  2. Disease-free survival (DFS)

    Time frame: Up to 5 years

    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.

  3. Acute Toxicity Profile

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

    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.

  4. Late Toxicity Profile

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

    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.

  5. Quality of life (QoL)

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Won Park, M.D.,Ph.D

CONTACT

[email protected]

+82-10-9933-2616

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study 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)

Acronym: POHIM-P3

Important dates

Study start
2024
Primary completion
2027
Study completion
2032
First posted
Jul 19, 2024
Registry last updated
Jul 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.