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

  • STATUS
    Recruiting
  • End date
    Jun 1, 2025
  • participants needed
    638
  • sponsor
    Peking Union Medical College Hospital
Updated on 12 March 2022
platelet count
paclitaxel
cancer
carcinoma
squamous cell carcinoma
metastasis
chemoradiotherapy
adenosquamous carcinoma
brachytherapy
external beam radiation therapy
adenocarcinoma
pet/ct scan
pet/ct
intensity-modulated radiation therapy
cervical neoplasm

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).

Description

This is a multicenter, open-label, phase III randomized clinical trial. Cervical cancer patients without evidence of para-aortic metastatic lymph nodes (MLNs) and with at least one of the following characteristics are included in the present study: (a) Number of pelvic MLNs ≥ 2; (b)Short diameter of pelvic MLNs ≥ 1.5cm; (c)Pelvic wall involvement. Patients are randomly assigned to pelvic irradiation group and prophylactic EFI group. Patients in pelvic irradiation group receive pelvic irradiation, intracavitary brachytherapy and concurrent chemotherapy. Patients in prophylactic EFI group receive irradiation for pelvis and para-aortic lymph nodes region, intracavitary brachytherapy and concurrent chemotherapy. The upper border of clinical target volume (CTV) is at the level of renal vessels for patients in prophylactic EFI group. A dose of 45-50.4 Gy is delivered to CTV with IMRT in both groups. Patients receive cisplatin based concurrent chemotherapy (single cisplatin or cisplatin plus paclitaxel). The primary endpoint is progression-free survival.

Details
Condition Uterine Cervical Neoplasms
Treatment Concurrent chemotherapy, Prophylactic extended-field Irradiation, Pelvic irradiation, Intracavitary brachytherapy, Intracavitary brachytherapy
Clinical Study IdentifierNCT03955367
SponsorPeking Union Medical College Hospital
Last Modified on12 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients must be informed of the investigational nature of this study and give written informed consent with 30 days before treatment
Age ≥18 years and ≤ 70 years
Patients with newly histologically confirmed cervical cancer, including squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma, et al
No evidence of para-aortic metastatic lymph nodes (MLNs) on CT, MRI or positron emission tomograph (PET)/CT
No evidence of distant metastasis (FIGO stage IVB)
At least meet one of the following characteristics
Number of pelvic MLNs ≥ 2
Short diameter of pelvic MLNs ≥ 1.5cm
Parametrial involvement to the pelvic wall #
Satisfactory performance: Eastern Cooperative Oncology Group (ECOG) score ≥ 2
Adequate marrow: neutrophile granulocyte count ≥1.5 _10^9/L, hemoglobin ≥ 80 g/L, platelet count ≥100_ 10^9/L
Normal liver and kidney function: Creatinine (Cr) < 1.5 mg/dl, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) < 2upper 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

With common iliac MLNs
Tumor extended to the lower third of the vagina
Tumor spread to mucosa of the bladder or rectum
Prior surgery (including pelvic or para-aortic lymph nodes resection, except for tumor biopsy), radiotherapy or chemotherapy to primary tumor or nodes
Prior malignancy
History of previous radiotherapy to the abdomen or pelvis
Pregnancy or lactation
Active inflammatory bowel disease, or history of severe stomach or duodenal ulcer
Active infection with fever
Patients with unacceptable risk that intracavitary brachytherapy can not be conducted
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
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