Pelvic RT Versus Prophylactic Extended-field RT in Patients With Cervical Cancer

• Status: Recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

To investigate the value of prophylactic extended-field irradiation (EFI), we conduct a randomized clinical trial to compare the efficacy and toxicity of pelvic irradiation and prophylactic EFI in selected patients with cervical cancer treated with definitive concurrent chemoradiotherapy. External beam radiation therapy is delivered with intensity-modulated radiation therapy (IMRT).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Collaborators: Affiliated Cancer Hospital of Zhengzhou University; Beijing Obstetrics and Gynecology Hospital; Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Cangzhou Central Hospital; China-Japan Union Hospital, Jilin University; First Affiliated Hospital of Chongqing Medical University; First Affiliated Hospital of Guangxi Medical University; First Affiliated Hospital Xi'an Jiaotong University; General Hospital of Benxi Iron & Steel Industry Group; General Hospital of Ningxia Medical University; Guizhou Provincial People's Hospital; Harbin Medical University Third Affiliated Hospital; Henan Provincial Hospital; Henan Provincial People's Hospital; Jiangsu Cancer Institute & Hospital; Jilin Provincial Tumor Hospital; Peking University First Hospital; Second Affiliated Hospital of Xi'an Jiaotong University; Second Hospital of Jilin University; Seventh Medical Center of PLA Army General Hospital; Shengjing Hospital; Tangshan People's Hospital; The 940th Hospital of Joint Logistics Support Force，PLA.; The Affiliated Hospital of Inner Mongolia Medical University; The Affiliated Tumor Hospital of Xinjiang Medical University; The First Affiliated Hospital of Zhengzhou University; The Second Affiliated Hospital of Dalian Medical University; the Seventh Medical Center of PLA General Hospital; Tumor Hospital of Gansu; West China Second University Hospital; Wuhan Union Hospital, China; Xi'an Gaoxin Hospital; Xi’an Gaoxin Hospital; Xiangya Hospital of Central South University; Zhejiang Cancer Hospital; Zhongnan Hospital of Wuhan University & Second Clinical Hospital of Wuhan University

Criteria

Inclusion Criteria:

1. Patients must be informed of the investigational nature of this study and give written informed consent with 30 days before treatment.

2. Age ≥18 years and ≤ 70 years.

3. Patients with newly histologically confirmed cervical cancer, including squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma, et al.

4. No evidence of para-aortic metastatic lymph nodes (MLNs) on CT, MRI or positron emission tomograph (PET)/CT.*

5. No evidence of distant metastasis (FIGO stage IVB).

6. At least meet one of the following characteristics:

1. Number of pelvic MLNs ≥ 2;

2. Short diameter of pelvic MLNs ≥ 1.5cm; *

3. Parametrial involvement to the pelvic wall ＃.

7. Satisfactory performance: Eastern Cooperative Oncology Group (ECOG) score ≥ 2.

8. Adequate marrow: neutrophile granulocyte count ≥1.5*10^9/L, hemoglobin ≥ 80 g/L, platelet count ≥100*10^9/L.

9. Normal liver and kidney function: Creatinine (Cr) < 1.5 mg/dl, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) < 2*upper limit of normal (ULN).

• MLNs refer to positive lymph nodes confirmed by PET/CT or lymph nodes with short diameter ≥ 1 cm on CT or MRI.

• Parametrial involvement to the pelvic wall is diagnosed with gynecological examination or MRI;

Exclusion Criteria:

1. With common iliac MLNs.

2. Tumor extended to the lower third of the vagina.

3. Tumor spread to mucosa of the bladder or rectum.

4. Prior surgery (including pelvic or para-aortic lymph nodes resection, except for tumor biopsy), radiotherapy or chemotherapy to primary tumor or nodes.

5. Prior malignancy.

6. History of previous radiotherapy to the abdomen or pelvis.

7. Pregnancy or lactation.

8. Active inflammatory bowel disease, or history of severe stomach or duodenal ulcer.

9. Active infection with fever.

10. Patients with unacceptable risk that intracavitary brachytherapy can not be conducted.

11. Any severe disease which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control, and emotional disturbance.