Neo-Adjuvant Chemotherapy and Conservative Surgery in Cervical Cancer to Preserve Fertility

Cervical Cancer Clinical Trial

— CONTESSA  

Official title:

FIGO 2018 Stage IB2 (≥2cm - <4 cm) Cervical Cancer Treated With Neoadjuvant Chemotherapy Followed by Fertility Sparing Surgery (CoNteSSa) / Neo-Adjuvant Chemotherapy and Conservative Surgery in Cervical Cancer to Preserve Fertility (NeoCon-F)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04483557
• Other study ID #: M20TES
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 1, 2020
• Est. completion date: March 2, 2024

Study information

• Verified date: June 2020
• Source: The Netherlands Cancer Institute
• Contact: Marie Plante, Dr.
• Phone: 418-691-5392
• Email: marie.plante[@]crhdq.ulaval.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The standard treatment of stage Ibl 2-4 cm cervical cancer in women who wish to preserve fertility is an abdominal radical trachelectomy with pelvic lymph node dissection. Since the number of take home babies after completing this procedure is below 10%, there is a need for exploration of alternative treatment modalities with better chances of preserving fertility at equal risk of recurrence.

Aim of the study is to assess the feasibility of preserving fertility in women with 2018 FIGO stage IB2 cervical cancer with lesions measuring >2cm - <4cm

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: March 2, 2024
• Est. primary completion date: March 2, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Patients must have histologically confirmed invasive cervical cancer with adenocarcinoma, adenosquamous or squamous histology and FIGO 2018 IB2 measuring >2cm to <4cm

• Patients must be =18 years of age, and < 40 years of age

• Patients must be premenopausal and wish to preserve fertility

• no prior therapy to treat their cancer lesion, patients with diagnostic cone or LEEP are allowed

• Eastern Cooperative Group (ECOG) performance status = 2

• Within 7 days of the proposed start of treatment, patients must have normal organ and marrow function

• No evidence of active uncontrolled infection

• Patient must have disease that is measurable per RECIST 1.1.

• Ability to understand and willing to sign a written informed consent document.

• A negative serum pregnancy test

Exclusion Criteria:

• Patients who are receiving any other investigational agents.

• Patients with other cancers requiring ongoing treatment.

• Patients with known / evidence of brain metastases

• Uncontrolled inter-current illness

• Patients who are pregnant or breastfeeding

Related Conditions & MeSH terms

• Cervical Cancer
• Cervical Carcinoma
• Uterine Cervical Neoplasms

Intervention

Drug:
• Paclitaxel, SUB09583MIG
If no metastases are observed, patients will start a short protocol of three courses of weekly neo-adjuvant chemotherapy (9 weeks). If response to chemotherapy results in a tumor of less than 2 cm, cervical conisation or a simple trachelectomy/portio amputation with application of a cerclage will be performed

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute	Princess Margaret Hospital, Canada

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To evaluate the patient reported outcomes quality of life (QOL)	QoL Questionnaires	3 year
Other	To evaluate ovarian function, FSH, following neoadjuvant chemotherapy and fertility sparing surgery.		2 year
Other	To explore the possibility of disease monitoring by HPV circulating DNA (ctDNA/cfDNA) and hypermethylated DNA (hmDNA) measurements in cervical scrapes as applicable.		3 year
Other	To evaluate the patient reported outcomes of sexual health	The Female Sexual Functioning Index (FSFI) is a 19-item measure assessing six domains of sexual functioning: Validation studies on sexually dysfunctional and matched control women have demonstrated excellent internal consistency and test-retest reliability	3 year
Other	To evaluate the patient reported outcomes of anxiety/depression	Hospital Anxiety and Depression Scale (HADS) . This is a 14-item self-report questionnaire for detecting depression and anxiety in a hospital outpatient setting. Both anxiety and depressive subscales were found to be reliable and valid measures of severity in emotional disorders	3 year
Other	To evaluate the patient reported outcomes of reproductive concerns in women undergoing FSS after NACT for stage FIGO 2018 IB2 cervical cancer	The Reproductive Concerns after Cancer (RCAC) is an 18-item measuring six domains of reproductive concerns of women with cancer: 1. Fertility potential; 2. Partner disclosure of fertility status; 3. Child's health; 4. Personal health; 5. Acceptance of possibly not having children; and 6. Becoming pregnant (24). The summary score range from 18 to 90 with high score indicating greater concern.	3 year
Other	To evaluate ovarian function (estradiol) following neoadjuvant chemotherapy and fertility sparing surgery.		2 year
Other	To evaluate ovarian function (AMH) neoadjuvant chemotherapy and fertility sparing surgery.		2 year
Primary	to determine the rate of functional uterus defined as successful fertility sparing surgery (FSS) with no adjuvant therapy	To assess the feasibility of preserving fertility in women with node negative, 2018 FIGO stage IB2 cervical cancer with lesions measuring >2cm - <4cm by administering neo-adjuvant chemotherapy (NACT) followed by fertility sparing surgery (FSS) and no adjuvant therapy	3 year
Secondary	To evaluate the safety of NACT in women with node negative, 2018 FIGO stage IB2 cervical cancer with lesions measuring >2cm - <4cm	To evaluate the safety of NACT in women with node negative, 2018 FIGO stage IB2 cervical cancer with lesions measuring >2cm - <4cm assessed as toxicities of NACT by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and the rate of completion of NACT	4 weeks after surgery
Secondary	To evaluate the response rate based on RECIST 1.1 following neoadjuvant chemotherapy for patients with node negative stage FIGO 2018 IB2 cervical cancer;		day 45
Secondary	To assess the rate of FSS		Surgery
Secondary	To evaluate the surgical complication rate following FSS by the Clavien-Dindo classification of surgical morbidity		4 weeks after surgery
Secondary	To evaluate the safety of the fertility sparing surgery (FSS) in women with node negative, FIGO 2018 stage IB2 cervical cancer measuring >2cm - <4cm measured as two and three-year recurrence free survival		3 year
Secondary	To evaluate overall survival (OS) up to two and three years for patients who undergo neoadjuvant chemotherapy followed by fertility sparing surgery		3 year