cervical cancer cervical carcinoma
Conditions
Interventions
If no metastases are observed, patients will start a short protocol of four
courses of weekly neo-adjuvant chemotherapy (12 weeks). If response to
chemotherapy results in a tumor of less than 2 cm,
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Stage Ib1 cervical cancer measuring *2 - *4 cm on physical examination and imaging in any direction * Histologic type: squamous cell carcinoma (SCC), adeno cell carcinoma (ACC), adeno-squamous cell carcinoma (ASC) * Age *18 years and * 40 years * MRI abdomen and pelvis, chest X-ray must be performed and negative for metastatic disease within 12 weeks of enrolment * No metastases on pelvic lymph node dissection
Exclusion criteria
Exclusion criteria: * Involvement of tumor in uterine corpus on MRI or hysteroscopy if performed * Evidence of metastatic disease on imagining (PET/CT/MRI) performed within 12 weeks of enrolment * other diagnosis of malignancy or evidence of other malignancy for 5 years before screening for this study (except non-melanoma skin cancer).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate safety and feasability of the combination of neo-adjuvant chemotherapy followed by less radical surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| need for adjuvant therapy (radical hysterectomy or (chemo)radiation, preservation of ovarian function, quality of life. | — |
Countries
Netherlands
Outcome results
None listed