Image Guided IMRT, Radiochemotherapy and MRI-based IGABT in Locally Advanced Cervical Cancer

NCT03617133RecruitingPHASE2INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Medical University of Vienna

Enrollment

1000

Start Date

2016-04-01

Completion Date

2021-12-31

Study Type

INTERVENTIONAL

Official Title

Image Guided Intensity Modulated External Beam Radiochemotherapy and MRI Based Adaptive BRAchytherapy in Locally Advanced CErvical Cancer

Interventions

Increased use of IC/IS technique in BTReduction of vaginal source loadingSystematic utilisation of IMRTUtilisation of daily IGRT (set-up according to bony structures)EBRT target concept related to the primary tumor (CTV-T) and internal motion; concepts for OAR contouringEBRT dose prescription and reportingAdaptation of EBRT nodal elective CTV according to risk of nodal and systemic recurrenceSystemic application of simultaneous chemotherapyReduction of overall treatment time

Conditions

Uterine Cervical Neoplasms

Eligibility

Age Range

18 Years – 99 Years

Sex

FEMALE

Inclusion Criteria:

* Cancer of the uterine cervix considered suitable for curative treatment with definitive radio-(chemo)therapy including MRI guided BT
* Positive biopsy showing squamous-cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix.
* Staging according to FIGO and TNM guidelines
* MRI of pelvis at diagnosis is performed
* MRI, CT or PET-CT of the retroperitoneal space and abdomen at diagnosis is performed
* MRI with the applicator in place at the time of (first) BT will be performed
* Para-aortic metastatic nodes below L1-L2 are allowed
* Patient informed consent

Exclusion Criteria:

* Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin
* Small cell neuroendocrine cancer, melanoma and other rare cancers in the cervix
* Metastatic disease above and beyond the retroperitoneal para-aortic L1-L2 interspace
* Previous pelvic or abdominal radiotherapy
* Previous total or partial hysterectomy
* Combination of preoperative radiotherapy with surgery
* Patients receiving BT only
* Patients receiving EBRT only
* Patients receiving neo-adjuvant chemotherapy or other forms of antineoplastic treatment apart from weekly concomitant cisplatin (40 mg/2). However, adjuvant chemotherapy in the form of 4 courses of 3 weekly Carboplatin (AUC 5) and Paclitaxel (155 mg/m2) is allowed according to departmental policy.
* Contra indications to MRI
* Contra indications to BT

Outcome Measures

Primary Outcomes

local control

Time frame: 5 years

nodal control

Time frame: 5 years

systemic control

Time frame: 5 years

overall survival

Time frame: 5 years

overall morbidity

Time frame: 5 years

health-related quality of life: physical functioning

European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire. Scores ranging from 0 to 100, higher scores indicating better functioning.

Time frame: 5 years

health-related quality of life: role functioning

European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire. Scores ranging from 0 to 100, higher scores indicating better functioning.

Time frame: 5 years

health-related quality of life: social functioning

European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire. Scores ranging from 0 to 100, higher scores indicating better functioning.

Time frame: 5 years

Secondary Outcomes

cancer specific survival

Time frame: 5 years

disease specific survival

Time frame: 5 years

Locations

Medical University of Vienna, Vienna, Austria

Image Guided IMRT, Radiochemotherapy and MRI-based IGABT in Locally Advanced Cervical Cancer