Clinical trial · Interventional
Postoperative Hypofractionated Intensity-modulated Radiation Therapy with Concurrent Chemotherapy in Cervical Cancer
Postoperative Hypofractionated Intensity-modulated Radiation Therapy with Concurrent Chemotherapy in Cervical Cancer: a Prospective Exploratory Trial (POHIM_CCRT Trial)
NCT03239613CI-TRIAL-00084318completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
To investigate the acute toxicities, late toxicities, and treatment results when the early cervical cancer patients are treated by concurrent chemotherapy with hypofractionated intensity-modulated radiotherapy (2.5 Gy X 16 fractions, once a day) after radical hysterectomy.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervix Cancer | — | UNRESOLVED | — |
| Chemotherapy, Concurrent | — | UNRESOLVED | — |
| Hypofractionated Dose | — | UNRESOLVED | — |
| Radiotherapy, Adjuvant | — | UNRESOLVED | — |
| Radiotherapy, Intensity-Modulated | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| POHIM-CCRT | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- POHIM-CCRT
- description
- postoperative adjuvant concurrent chemotherapy with hypofractionated IMRT (2.5 Gy/fraction, 16 fractions, once a day)
- interventionNames
- Other: POHIM-CCRT
Primary outcomes (1)
- measure
- Acute toxicities according to CTCAE v4.0
- timeFrame
- 3 months
- description
- evaluation of acute toxicities within 3months after radiotherapy according to CTCAE v4.0
Secondary outcomes (2)
- measure
- Late toxicities according to CTCAE v4.0
- timeFrame
- 5-years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * histologically confirmed cervical cancer * radical hysterectomy and pelvic lymph node dissection was done * histologically indicated adjuvant chemoradiotherapy (more than one as below) * positive pelvic lymph node metastasis * positive parametrial invasion * positive tumor involvement on surgical margin * ECOG performance status 0 or 1 * Bone marrow function: granulocyte ≥1.0 x 1000/µl, platelet ≥30 x 1000/µl, hemoglobin ≥10 g/dl * Kidney function: Creatinine \<2.0 mg/dL, Bilirubin 1.5 mg/dl Exclusion Criteria: * positive distant metastasis (including retroperitoneal lymph node metastasis) * previous history of pelvic radiotherapy * more than 3 months after radical surgery for cervical cancer * neoadjuvant chemotherapy was done * previous history of other carcinoma except for thyroid cancer, skin cancer, in situ carcinoma on cervix
References
Publications (1)
- DERIVEDCho WK, Park W, Kim SW, Lee KK, Ahn KJ, Choi JH. Postoperative Hypofractionated Intensity-Modulated Radiotherapy With Concurrent Chemotherapy in Cervical Cancer: The POHIM-CCRT Nonrandomized Controlled Trial. JAMA Oncol. 2024 Jun 1;10(6):737-743. doi: 10.1001/jamaoncol.2024.0565. PMID 38662364