Clinical trial · Interventional
Comparison of Conventional and Hypofractionated IMRT in High-Risk Cervical Cancer Post-Radical Hysterectomy
Postoperative Conventional Versus Hypofractionated Intensity-modulated Radiation Therapy With Concurrent Chemotherapy in Cervical Cancer: A Prospective Multicenter Randomized Phase III Trial (POHIM_P3 Trial)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Cervical Neoplasms | Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional Fractionated IMRT | Radiation | — | UNRESOLVED |
| Hypofractionated IMRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Conventional Fractionation Group
- description
- 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.
- interventionNames
- Radiation: Conventional Fractionated IMRT
- type
- EXPERIMENTAL
- label
- Hypofractionation Group
- description
- 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.
- interventionNames
- Radiation: Hypofractionated IMRT
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDCho 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. PMID 40676909