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Feasibility Study: Conservative Treatment in Cervical Cancer

NCT02323841UNKNOWNEARLY PHASE1INTERVENTIONAL

Summary

Currently conservative treatment for patients of childbearing affected by cervical cancer is reserved for women with FIGO stage IA2 - IB1 with tumor size less than 2 cm . The trachelectomy and the cone biopsy with pelvic lymphadenectomy are the choice for these patients wishing to preserve their reproductive function. In this context , recently literature show the results about the use of neo-adjuvant chemotherapy about the reduction of tumor volume and therefore the magnitude of the subsequent surgical treatment (including patients with tumors larger than 2 cm ). So it becomes crucial a prospective analysis on the possibility to include in this type of treatment patients with stage IB1 and IIA1 with tumor size greater than 2 cm ( up to 4 cm ) . The current study , in fact , would like to do a prospective evaluation on the advantages of neo-adjuvant chemotherapy in the possibility of broadening the inclusion criteria to conservative treatment in women , suffering from cervical cancer, stage IB1 and IIA1 ( with tumor volume between 2 and 4 cm) and wishing to preserve their reproductive function.

Key Facts

Lead Sponsor

Catholic University of the Sacred Heart

Enrollment

Start Date

2014-03-01

Completion Date

2014-03-01

Study Type

INTERVENTIONAL

Official Title

Feasibility Study: Conservative Treatment in Cervical Cancer FIGO Stage IB1-IIA1 > 2cm

Interventions

conservative treatment

Conditions

Stage IB1 Cervical Cancer

Eligibility

Age Range

18 Years – 40 Years

Sex

FEMALE

Inclusion Criteria:

* Squamous cervical cancer or adenocarcinoma in FIGO stage IB1-IIA, tumor volume between \> 2 and ≤ 4 cm (instrumental evaluation).
* Informed consensus
* Childbearing
* Fertility (through US and ormonal withdrawal pre - e post neoadjuvant chemotherapy
* ASA (American Society of Anesthesiologist) Class \< 2

Exclusion Criteria:

* ongoing pregnancy

Outcome Measures

Primary Outcomes

pregnancy rate

time of pregnancy. Case of miscarriage, pre-term delivery or full term delivery.

Time frame: 3 years

Secondary Outcomes

disease free survival

time of disease free surviva

Time frame: 5 years

Overall survival

Time to the last follow up/death

Time frame: 5 years

Locations

Giovanni Scambia, Rome, Italy

Linked Papers

2021-05-31

The role of MRI in cervical cancer > 2 cm (FIGO stage IB2-IIA1) conservatively treated with neoadjuvant chemotherapy followed by conization: a pilot study

Abstract Introduction MRI is very accurate in selecting young women with cervical cancer for fertility-sparing surgery (FSS), in particular radical hysterectomy (RH). In order to improve obstetrical outcomes, neoadjuvant chemotherapy (NACT) followed by cold knife conization (CKC) has been proposed as alternative technique. Objective To investigate the role of MRI in evaluation of response to treatment after neoadjuvant chemotherapy (NACT), followed by CKC, in patients with cervical cancer FIGO stage IB2-IIA1 with tumor size 2 – 4 cm, desiring to preserve their fertility. Methods 13 young women (23–36 years old) with cervical cancer stage IB2-IIA1 desiring to preserve their fertility were included. Tumor diameter at baseline and after treatment was detected on 1.5 T MRI. Treatment response was assessed according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and then compared to histopathology result. Results MRI correctly assessed 11 out of 13 cases, according to RECIST 1.1, compared to histopathology. Among these 7 patients with partial response (PR), 2 cases of CR, 1 SD and 1 PD with persistence or enlargement of primary tumor. Conclusion Our pilot study supports the usefulness of MRI in assessment of treatment response after NACT, followed by CKC. Trial registration number ClinicalTrials.gov: NCT02323841

2020-10-20

Neoadjuvant chemotherapy followed by conization in stage IB2–IIA1 cervical cancer larger than 2 cm: a pilot study

To evaluate feasibility of neoadjuvant chemotherapy (NACT) followed by cold-knife conization (CKC) in patients with 2018 FIGO stage IB2-IIA1 cervical cancer who desired to maintain fertility. Pilot study of conization after chemotherapy in stage IB2-IIA1 >2 cm cervical cancer. University hospital. From 2014 to 2018, 25 patients, <40 years of age, were enrolled. After laparoscopic pelvic lymph-node assessment, NACT with cisplatin/paclitaxel q21 was administered to eligible patients. Responsive patients were treated with CKC. Obstetrical outcome: pregnancy rate. Oncologic outcome. Thirteen out of 25 patients were eligible for fertility-sparing treatment. Oncologic outcome: The clinical overall response rate was 84.5% (11 out of 13 patients). One patient achieved stable disease, was managed by radical surgery, and is still alive; another one experienced progression of disease and died after 15 months. The optimal pathologic response was 69.1%. In the setting of fertility preservation patients, the median follow-up was 37 months (range 18-76). In this group we registered one distant recurrence, 12 months after CKC, in the liver; the patient is still alive and without evidence of disease. Obstetrical outcome: Among the nine patients amenable, three tried to conceive, and two spontaneous pregnancy occurred a few months after the end of treatment, for a pregnancy rate of 66.7%. This pilot study supports the feasibility of CKC after NACT as conservative treatment in stage IB2-IIA1 cervical cancer, with oncologic outcomes similar to those reported for trachelectomy in the same stage and with potential benefits in terms of obstetrical outcomes. NCT02323841.

Linked Investigators

Benedetta Gui