Comparing Conventional and Hypofractionated Radiation Therapy with Chemotherapy After Cervical Cancer Surgery: A Prospective Multicenter Phase 3 Study

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0009607

Enrollment

284

Registered

2024-07-08

Start date

2024-06-17

Completion date

Unknown

Last updated

2024-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Radiation : The intervention group are divided into two: conventional fractionation and hypofractionation. Patients will be randomly assigned 1:1 to either the conventional fractionation group or the

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: (1) Histologically confirmed cervical cancer (2) Histologically confirmed Squamous cell carcinoma, Adenocarcinoma or Adenosquamous carcinoma (3) Patients who underwent radical hysterectomy and pelvic lymph node dissection (4) Patients with pathological indications for radiotherapy A. Pelvic lymph node metastasis B. Parametrium involvement C. Positive surgical margins (5) Age 20 - 75 years (6) ECOG performance status 0-1 (7) Adequate bone marrow function: Granulocytes =1.0 x 103/µl, Platelets =30 x 103/µl, Hemoglobin =9.5 g/dl (8) Adequate renal and liver function (Creatinine <2.0 mg/dL, Bilirubin 1.5 mg/dl) (9) Signed informed consent

Exclusion criteria

Exclusion criteria: (1) Distant metastasis (2) Previous pelvic radiotherapy (3) More than 3 Months post-radical hysterectomy (4) Untreated serious acute disease without Cervical cancer (5) Nooadjuvant chemotherapy (6) Inability to undergo concurrent chemoradiotherapy (7) History of other cancer within 5 years (except for thyroid cancer, skin cancer, carcinoma in situ)

Design outcomes

Primary

Measure	Time frame
Progression-free survival rate when concurrent radiotherapy is applied on postoperative cervical cancer	—

Secondary

Measure	Time frame
Acute adverse events when concurrent radiotherapy is applied on postoperative cervical cancer;Time to disease progression when concurrent radiotherapy is applied after hysterectomy for cervical cancer;Local control rate for the radiation treatment area;Overall survival rate when radiation therapy with concurrent chemotherapy applied after hysterectomy for cervical cancer;Chronic side effects when radiation therapy with concurrent chemotherapy was applied surgery after hysterectomy for cervical cancer	—

Measure

Time frame

Acute adverse events when concurrent radiotherapy is applied on postoperative cervical cancer;Time to disease progression when concurrent radiotherapy is applied after hysterectomy for cervical cancer;Local control rate for the radiation treatment area;Overall survival rate when radiation therapy with concurrent chemotherapy applied after hysterectomy for cervical cancer;Chronic side effects when radiation therapy with concurrent chemotherapy was applied surgery after hysterectomy for cervical cancer

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Countries

Korea, Republic of

Contacts

Public ContactYeonseo Lee

Samsung Medical Center

rnysleej@google.com+82-2-2008-4470

Outcome results