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

NCT06509724 | Recruiting Phase 3 DMC

• 2 other identifiers: SMC 2024-04-058KROG 24-05
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

Brief 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. 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

Uterine Cervical Neoplasms

Outcome Measures

Primary Outcomes (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.

  Up to 3 years

Secondary Outcomes (5)

• Overall survival (OS)

  Up to 5 years

• Disease-free survival (DFS)

  Up to 5 years

• Acute Toxicity Profile

  During treatment and up to 3 months post-treatment

• Late Toxicity Profile

  From 3 months post-treatment up to 5 years

• Quality of life (QoL)

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

Study Arms (2)

Conventional Fractionation Group

ACTIVE COMPARATOR

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.

Radiation: Conventional Fractionated IMRT

Hypofractionation Group

EXPERIMENTAL

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.

Radiation: Hypofractionated IMRT

Interventions

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

Conventional Fractionation Group

Hypofractionated IMRT RADIATION

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

Hypofractionation Group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, Gangnam-gu, 06351, South Korea

RECRUITING

Related Publications (1)

• 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. 2025 Jul 4. doi: 10.3802/jgo.2026.37.e4. Online ahead of print.

  PMID: 40676909 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Won Park, M.D.,Ph.D

CONTACT

+82-10-9933-2616; wonro.park@samsung.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 19, 2024
• Study Start: July 19, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 31, 2032
• Last Updated: July 26, 2024

Record last verified: 2024-07

Locations

KR (1)