Comparing pelvic radiation to extended-field radiation for cervical cancer treatment
Pelvic Irradiation Versus Prophylactic Extended-field Irradiation in Selected Patients With Cervical Cancer Treated With Concurrent Chemoradiotherapy: A Multicenter, Open-label, Randomized, Phase 3 Trial
This study is testing whether extended-field radiation is better than pelvic radiation for treating cervical cancer in patients who are also receiving chemotherapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 638 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Beijing, Beijing and 1 other locations) |
| Trial ID | NCT03955367 on ClinicalTrials.gov |
What this trial studies
This multicenter, open-label, phase III randomized clinical trial aims to evaluate the efficacy and toxicity of pelvic irradiation versus prophylactic extended-field irradiation (EFI) in patients with cervical cancer undergoing concurrent chemoradiotherapy. Eligible patients, who do not have para-aortic metastatic lymph nodes, will be randomly assigned to receive either pelvic irradiation or EFI, with both groups also receiving intracavitary brachytherapy and chemotherapy. The primary endpoint of the study is progression-free survival, with a focus on determining the potential benefits of extended-field irradiation in this patient population.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18 to 70 with newly diagnosed cervical cancer and specific characteristics indicating a higher risk of metastasis.
Not a fit: Patients with evidence of para-aortic metastatic lymph nodes or distant metastasis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes and survival rates for patients with cervical cancer.
How similar studies have performed: Other studies have explored similar approaches, but the specific efficacy of prophylactic extended-field irradiation in this context remains to be fully established.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing and 1 other locations
- Peking Union Medical College Hospital — Beijing, Beijing, China (Recruiting)
- First Affiliated Hospital Xi'an Jiaotong University — Xi'an, Shanxi, China (Recruiting)
Study contacts
- Principal investigator: Ke Hu — Peking Union Medical College Hospital
- Study coordinator: Ke Hu
- Email: huk@pumch.cn
- Phone: +86-01069155487
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.