Neoadjuvant Chemotherapy in Cervical Cancer

NCT05384366 | Completed Phase 3 DMC

• 1 other identifier: NeoCx
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Cervical cancer represents the second commonest cancer in women worldwide, with 500,000 new cases and 300,000 deaths reported yearly. Among cervical cancer cases, 80% occur in developing countries and about 70% are identified as advanced cancer. According to the International Federation of Gynecology and Obstetrics (FIGO) staging system, a locally advanced cervical cancer includes stage IB2 to IIB. Treatment modalities include radical surgery with or without adjuvant radiotherapy (RT), Neoadjuvant Chemotherapy (NAC) plus radical hysterectomy with or without adjuvant RT, and concomitant chemo radiation. Currently, platinum based concurrent chemoradiotherapy is the gold standard for locally advanced cervical carcinoma. Neoadjuvant chemotherapy has many advantages: decreasing tumor size making surgery easier with improved rate of complete resection, decreased pelvic recurrence rate significantly, decreasing rate of parametrial invasion and lymph node metastasis, better brachytherapy distribution, minimal radiation toxicity, and 15% absolute increase of 5-year survival. This study will evaluate various factors i.e. patient related (Age, Menopausal status, HPV, HIV, Comorbidities), Tumor related pathological stages (TNM), grade, lymphovascular perineural invasion, lymph nodes, extranodal extension, tumor margins including radial margin, type of tumor i.e. Adeno vs squamous, mutation profile and Treatment related factors (type of NAC, duration of NAC, no of cycles of NAC).

Conditions

Cervix Cancer; Cervical Cancer; Cancer of the Uterine Cervix

Keywords

cancer; cervix; neoadjuvant chemotherapy; predictors

Outcome Measures

Primary Outcomes (2)

• Clinical Response

  Response to intervention by RACIST criteria 1.1

  21 days after completion of third cycles

• Pathological response

  Pathological response after evaluation of surgical specimen and pathological staging

  6 months

Study Arms (1)

Neoadjuvant chemotherapy

OTHER

Patients receiving neoadjuvant paclitaxel 175mg/m2 and carboplatin (AUC5) at three weekly interval by intravenous route

Drug: Neoadjuvant chemotherapy

Interventions

Neoadjuvant chemotherapy DRUG

doublet of taxane and carboplatin

Also known as: Paclitaxel and Carboplatin

Neoadjuvant chemotherapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: The disease occurs only in females
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients receiving NACT followed by Surgery/RT and willing to give consent will be included in study
• FIGO Stage Ib/ IIa/ IIb
• Age more than 18 yrs

You may not qualify if:

• FIGO Stage Ia/ III/ IV
• Patients who received treatment earlier
• Pregnant/ lactating women
• Second primary cancer

Sponsors & Collaborators

• Banaras Hindu University: lead

Study Sites (1)

Banaras Hindu University

Varanasi, Uttar Pradesh, 221005, India

Location

Related Publications (8)

• Rose PG. Combined-modality therapy of locally advanced cervical cancer. J Clin Oncol. 2003 May 15;21(10 Suppl):211s-217s. doi: 10.1200/JCO.2003.01.222.

  PMID: 12743137 BACKGROUND

• Katsumata N, Yoshikawa H, Kobayashi H, Saito T, Kuzuya K, Nakanishi T, Yasugi T, Yaegashi N, Yokota H, Kodama S, Mizunoe T, Hiura M, Kasamatsu T, Shibata T, Kamura T; Japan Clinical Oncology Group. Phase III randomised controlled trial of neoadjuvant chemotherapy plus radical surgery vs radical surgery alone for stages IB2, IIA2, and IIB cervical cancer: a Japan Clinical Oncology Group trial (JCOG 0102). Br J Cancer. 2013 May 28;108(10):1957-63. doi: 10.1038/bjc.2013.179. Epub 2013 May 2.

  PMID: 23640393 BACKGROUND

• Singh U, Ahirwar N, Rani AK, Singh N, Sankhwar P, Qureshi S. The efficacy and safety of neoadjuvant chemotherapy in treatment of locally advanced carcinoma cervix. J Obstet Gynaecol India. 2013 Aug;63(4):273-8. doi: 10.1007/s13224-012-0342-6. Epub 2013 Mar 12.

  PMID: 24431655 BACKGROUND

• Osman M. The role of neoadjuvant chemotherapy in the management of locally advanced cervix cancer: a systematic review. Oncol Rev. 2014 Sep 23;8(2):250. doi: 10.4081/oncol.2014.250. eCollection 2014 Sep 23.

  PMID: 25992238 BACKGROUND

• Sardi JE, Giaroli A, Sananes C, Ferreira M, Soderini A, Bermudez A, Snaidas L, Vighi S, Gomez Rueda N, di Paola G. Long-term follow-up of the first randomized trial using neoadjuvant chemotherapy in stage Ib squamous carcinoma of the cervix: the final results. Gynecol Oncol. 1997 Oct;67(1):61-9. doi: 10.1006/gyno.1997.4812.

  PMID: 9345358 BACKGROUND

• Takatori E, Shoji T, Omi H, Kagabu M, Miura F, Takeuchi S, Kumagai S, Yoshizaki A, Sato A, Sugiyama T. Analysis of prognostic factors for patients with bulky squamous cell carcinoma of the uterine cervix who underwent neoadjuvant chemotherapy followed by radical hysterectomy. Int J Clin Oncol. 2015 Apr;20(2):345-50. doi: 10.1007/s10147-014-0702-6. Epub 2014 May 14.

  PMID: 24825458 BACKGROUND

• Koensgen D, Sehouli J, Belau A, Weiss M, Stope MB, Grokopf V, Eichbaum M, Ledwon P, Lichtenegger W, Zygmunt M, Kohler G, Mustea A. Clinical Outcome of Neoadjuvant Radiochemotherapy in Locally Advanced Cervical Cancer: Results of an Open Prospective, Multicenter Phase 2 Study of the North-Eastern German Society of Gynecological Oncology. Int J Gynecol Cancer. 2017 Mar;27(3):500-506. doi: 10.1097/IGC.0000000000000894.

  PMID: 28187089 BACKGROUND

• Di Donato V, Schiavi MC, Ruscito I, Visentin VS, Palaia I, Marchetti C, Fischetti M, Monti M, Muzii L, Benedetti Panici P. Effects of Neoadjuvant Chemotherapy Plus Radical Surgery as Front Line Treatment Strategy in Patients Affected by FIGO Stage III Cervical Cancer. Ann Surg Oncol. 2016 Dec;23(Suppl 5):841-849. doi: 10.1245/s10434-016-5597-1. Epub 2016 Sep 27.

  PMID: 27678502 BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Neoplasms

Interventions

Neoadjuvant Therapy; Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Manoj Pandey, MS, PhD

  Banaras Hindu University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients with locally advanced carcinoma of the uterine cervix were recruited for assessment of clinical and pathological therapeutic response. Multivariate analysis was conducted to predict the independent predictors of response

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 20, 2022
• Study Start: August 1, 2020
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: May 20, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 6 months
• Access Criteria: on request

Locations

IN (1)