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CONCERV Studie


- candidate number26920
- NTR NumberNTR6263
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-mrt-2017
- Secondary IDsNCT01048853 
- Public TitleCONCERV Studie
- Scientific TitleConservative Surgery for Women with Low-Risk, Early Stage Cervical Cancer
- ACRONYMCONCERV
- hypothesisTo evaluate the safety and feasibility of performing conservative surgery in women with stage IA2 or IB1 carcinoma of the cervix with favorable pathologic features
- Healt Condition(s) or Problem(s) studiedCervix cancer
- Inclusion criteriaHistologically confirmed squamous cell carcinoma of the cervix (any grade) or Histologically confirmed grade 1 or 2 adenocarcinoma of the cervix
2. FIGO stage IA2 or IB1 disease
3. Tumor diameter <2 cm on physical exam and on imaging studies (if performed)
4. No lymphovascular space invasion (LVSI) present on biopsy or previous cone
5. Less than 10mm of cervical stromal invasion
6. Cone margins and endocervical curettage (ECC) specimen negative for invasive cancer, cervical intraepithelial neoplasia (CIN) CIN II, CIN III or adenocarcinoma-in-situ. (A negative margin is defined as no invasive cancer within 1.0mm of both the endocervical and ectocervical margins and no AIS or CIN II or CIN III at the inked or cauterized margin; one repeat cone and ECC permitted)
7. Patients are eligible for the study when a cone and ECC are performed prior to pre-enrollment in the study, and pathologic eligibility criteria are met. The cone and ECC must be performed within 12 weeks prior to pre-enrollment in the study. If the cone and ECC performed prior to pre-enrollment do not meet the pathologic criteria, patients may be pre-enrolled and are allowed 1 repeat cone & ECC after pre-enrollment in order to meet pathologic eligibility criteria. (see section 6.1)
8. Patients must sign an approved informed consent document
9. If patient is of childbearing potential, she must have a negative blood or urine pregnancy test within 14 days of surgical treatment on study.
10. Imaging with Positron emission tomography (PET) scan, computed tomography (CT) scan of the abdomen and pelvis, and/or magnetic resonance imaging (MRI) of the abdomen and pelvis must be performed and negative for metastatic disease within 12 weeks of enrollment.
- Exclusion criteria1. Clear cell, neuroendocrine, adenosquamous, serous carcinoma or other high-risk histologies
2. Grade 3 adenocarcinoma
3. FIGO stage IA1, IB2, II, III or IV disease
4. Tumors >2 cm in diameter on physical exam or imaging studies
5. Presence of LVSI
6. Greater than or equal to 10mm of cervical stromal invasion
7. Cone margins or ECC specimen positive for invasive cancer, CIN II, CIN III or adenocarcinoma-in-situ (one repeat cone permitted)
8. Neoadjuvant radiation therapy or chemotherapy for cervical cancer
9. Patients unwilling or unable to provide informed consent for the study
10. Evidence of metastatic disease on PET, CT, and/or MRI performed within 12 weeks of enrollment
11. Patients who have had a simple hysterectomy (cut through hysterectomy)
- mec approval receivedno
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-apr-2017
- planned closingdate1-sep-2018
- Target number of participants10
- InterventionsThis is a prospective, multi-institutional cohort study evaluating the outcomes of performing conservative surgery in women with stage IA2-IB1 cervical cancer with favorable pathologic characteristics. Up to 195 total patients will be enrolled to this study in order to accrue 100 evaluable patients.
- Primary outcomeImmediate Failure Rate [ Time Frame: 5 Years ]
The immediate failure rate is defined as residual disease in the simple hysterectomy specimen.
- Secondary outcomeRecurrence rate after two years
- Timepoints01-04-2017-01-09-2018
- Trial web site
- status[default]
- CONTACT FOR PUBLIC QUERIESDr Nienke E. van Trommel
- CONTACT for SCIENTIFIC QUERIESDr Nienke E. van Trommel
- Sponsor/Initiator Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI AVL)
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryRadical hysterectomy with pelvic lymph node dissection is the current standard for the treatment of early stage cervical cancer. While this is an effective treatment, it is associated with morbidity due to removal of the parametrium, which contains autonomic nerve fibers associated with bladder, bowel and sexual function. Several retrospective studies have shown that in early stage cervical cancer with favorable pathologic characteristics, the parametrial involvement is only 0 to 0.6%.

Primary Objective:
1. To evaluate the safety and feasibility of performing conservative surgery in women with stage IA2 or IB1 carcinoma of the cervix with favorable pathologic features

Secondary Objectives:
1. To estimate the cervix cancer recurrence rate at 2 years in women treated with conservative surgery for stage IA2 or IB1 carcinoma of the cervix with favorable pathologic features
2. To compare pelvic lymph node involvement in patients undergoing conservative surgery with historical data from matched patients treated with radical hysterectomy
3. To estimate the sensitivity of sentinel lymph node biopsy in the determination of pelvic lymph node metastases in this group of patients
4. To compare the treatment-associated morbidity in patients undergoing conservative surgery with historical data from matched patients treated with radical hysterectomy
5. To assess quality of life factors, sexual functioning, symptoms and satisfaction with healthcare decisions in this group of patients
- Main changes (audit trail)
- RECORD17-mrt-2017 - 29-apr-2017


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