Comparing Stereotactic Radiotherapy and Brachytherapy for Cervical Cancer Treatment
Randomized Phase II Study to Measure the Safety and Efficacy of Concomitant CT/RT Followed by Ablative Stereotactic Radiotherapy (SABR) vs Brachytherapy in Patients With Cervical Carcinoma in Clinical Stage IB3-IIIC1 at INCAN
NA · National Institute of Cancerología · NCT06560697
This study is testing whether a new type of radiation therapy called SABR is safer and more effective than the traditional brachytherapy for treating locally advanced cervical cancer after initial treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | National Institute of Cancerología (other gov) |
| Drugs / interventions | Bevacizumab, chemotherapy |
| Locations | 1 site (Mexico City, Tlalpan) |
| Trial ID | NCT06560697 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the safety and efficacy of stereotactic ablative radiotherapy (SABR) versus traditional intracavitary brachytherapy in patients with locally advanced cervical cancer. Participants will be randomly assigned to receive either SABR or brachytherapy after initial chemotherapy and radiotherapy. The study will evaluate local control, overall survival, progression-free survival, and quality of life using standardized questionnaires. By providing a direct comparison of these two treatment modalities, the trial seeks to address gaps in existing literature and potentially establish SABR as a viable alternative to brachytherapy.
Who should consider this trial
Good fit: Ideal candidates include women over 18 years old with histologically confirmed cervical cancer staged IB3-IIIC1 who have not received prior treatment.
Not a fit: Patients with cervical cancer who are not eligible for cisplatin treatment or have received prior therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a less invasive and more effective treatment option for patients with cervical cancer.
How similar studies have performed: While there is limited prospective data comparing these two approaches, previous studies have shown promising results for SABR in local control, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. People with cervical cancer \>18 years of age.
2. Signed informed consent form approved by the regulatory committees of both institutes and, obtained before each procedure related to the protocol, and that is not considered part of the normal care of the patient.
3. Able to comply with scheduled visits, treatment schedules, laboratory and imaging studies, and completing quality of life questionnaires.
4. Histological confirmation of CaCu and staged as IB3-IIIC1.
5. Squamous cell, adenosquamous, or adenocarcinoma histology.
6. No prior treatment for cervical cancer.
7. With disease measurable by CT, MRI, or PET/CT according to REC 1.1 criteria. This measurement must be carried out 28 days before randomization.
8. Functional status of 0-2 according to WHO criteria.
9. Charlson Comorbidity Index of 1-4
10. Candidates to receive cisplatin.
11. Normal hematological, kidney, and hepatic function according to:
Hematological:
Hemoglobin equal to or \>10g/L. (With the possibility of transfusion prior to treatment to reach this hemoglobin level).
Leukocytes \>4000/mm3. Platelets\>100,000mm3. Neutrophils \>1500 / μL
Hepatic:
Total bilirubin \<1.5 X times the normal value. Transaminases \<1.5 X times the normal value.
Renal:
Creatinine \<1.3mg/dl or creatinine clearance \> 40 mL/minute (using the Cockcroft/Gault formula).
Women: DepCr = (140 - Age in years) x Weight in kg x 0.85
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ 72 x Serum Creatinine in mg/dL Men: DepCr = (140 - Age in years) x Weight in kg x 1.00
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ 72 x Serum Creatinine in mg/dL
12. Chest tomography without metastatic disease or infectious diseases.
13. Negative pregnancy test in women of childbearing age.
14. Not a candidate for another clinical trial within the institution.
Exclusion Criteria:
1. Patients with small-cell carcinoma or other rare histologies (glassy cell carcinoma, melanoma, sarcomas, lymphomas)
2. Patients with non-measurable disease.
3. Patients in whom pregnancy is confirmed during the recruitment procedure.
4. Clinical stages IIIC2-IVB.
5. Serious infections or diseases that can be reactivated with the use of chemotherapy or that could limit its use (hepatitis or HIV).
6. Pre-existing neuropathy of any etiology.
7. Concomitant treatment with another experimental drug.
8. Mental illnesses: With the intention of maximizing adherence to the study, those patients who are at risk of imminent physical aggression (evident during the interview), have intellectual disabilities or autism, and who come for consultation due to coercion will not be included in the study. their accompanying Severe major depressive disorder, with or without psychotic symptoms; patients in whom a psychiatric diagnosis coexists in addition to the abuse of some recreational substance, eating disorders, schizophrenia, or Bipolar-type Schizoaffective Disorder.
9. Grade 3 obesity with body mass index \>40kg/m2 according to the World Health Organization: Patients treated with pelvic radiotherapy and a body mass index \>40kg/m2 are associated with a decrease in quality of life due to sexual, intestinal, genitourinary alterations, as well as greater toxicity due to oncological treatments offered such as intracavitary brachyter in which the positioning of the equipment in the vaginal area is significantly difficult in sedated patients. Patients with grade III obesity will not be included.
10. Any patient who is absent from follow-up for 5 subsequent appointments will be excluded from the study.
11. History of total or partial hysterectomy.
12. Patients with a history of neoadjuvant chemotherapy or use of another antineoplastic drug differ from cisplatin (40 mg/m2).
13. History of use of Bevacizumab to manage a pathology other than CC or intention to use this drug as part of the treatment of CC.
15\. Charlson Comorbidity Index \>5 16. Synchronous Cancer except non-melanoma Skin Cancer. 17. History of pelvic irradiation for metachronous cancer. 18. Inflammatory bowel disease or collagen diseases. 19. Patients with severe immunosuppression (transplant or treatment with immunosuppressive drugs).
20\. Patients who do not sign the informed consent form. 21. Suspected alcohol or recreational drug abuse. 22. Participation in any other clinical trial in the last 90 days prior to protocol recruitment.
23\. Any illness or disability not covered by the exclusion criteria that, in the researchers' opinion, may put the patient's safety and compliance with the protocol at risk.
24\. Patients with a percentage of rectal circumference receiving a dose of 15Gy \>62.7%
Where this trial is running
Mexico City, Tlalpan
- Instituto Nacional de Cancerologia — Mexico City, Tlalpan, Mexico (RECRUITING)
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.
Conditions: Uterine Cervical Neoplasm