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

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


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).


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.

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


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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note