Postoperative Conventional Versus Hypofractionated Intensity-modulated Radiation Therapy With Concurrent Chemotherapy in Cervical Cancer: A Prospective Multicenter Randomized Phase III Trial (POHIM_P3 Trial)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 248
- 试验地点
- 2
- 主要终点
- Local control rate for the radiation treatment area
研究概览
简要总结
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.
详细描述
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Local control rate for the radiation treatment area
时间窗: 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.
次要结局
- Quality of life (QoL)(Baseline, end of treatment, 6 months post-treatment, and annually up to 5 years)
- Overall survival (OS)(Up to 5 years)
- Disease-free survival (DFS)(Up to 5 years)
- Late Toxicity Profile(From 3 months post-treatment up to 5 years)
- Acute Toxicity Profile(During treatment and up to 3 months post-treatment)
研究者
Won Park
Professor
Samsung Medical Center