AzTrials
AzTrials

Cervix CancerPhase 3NCT05384366

Neoadjuvant Chemotherapy in Cervical Cancer

A Phase 3 study testing Neoadjuvant chemotherapy in people with Cervix Cancer and Cervical Cancer, run by Banaras Hindu University at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years, women only
What is being tested?
Neoadjuvant chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteIndia
Study dates
1 Aug 2020to 31 Mar 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

India1 site

  • Banaras Hindu University

    Varanasi, Uttar Pradesh, 221005

Other trials in India

About this study

Official title: To Study the Factors Affecting Treatment Responses in Patients With Uterine Cervical Carcinoma Undergoing Neoadjuvant Chemotherapy

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.

Read more

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).

Read the detailed description

This is a single group prospective study to evaluate factors affecting treatment responses in uterine cervical carcinoma. All patients who will be receiving NAC followed by surgery will be included and assessed for various defined factors influencing response. Responses will be assessed by RECIST 1.1 criteria.

  1. All patients of cervical growth will be evaluated. Initial clinical evaluation, biopsy and if positive, HPV DNA status will be done. On confirmation of malignancy further staging will be done by FIGO Classification. Imaging will include contrast enhanced computed tomography (CECT) abdomen or Magnetic resonance imaging (MRI) pelvis and ultrasound (USG) abdomen. Routine blood investigations, chest X-ray (CXR) and Electrocardiography (ECG) will be done.
  2. In recruited patients, 3 cycles of NAC consisting of Paclitaxel (175 mg/m2) and Carboplatin (AUC5) at 21 day intervals were given.
  3. Adverse reactions if any were recorded as WHO toxicity grades.
  4. Evaluation of response was done after end of 2nd cycle of chemotherapy with clinical examination and Imaging (CT/MRI) by RECIST 1.1 criteria.
  5. Response was divided into two groups- 1) Complete/ Partial response 2) Poor response/ Stable disease/ Progressive disease. Patients with Poor response/ stable disease/ progressive disease will undergo concurrent chemoradiation (CCRT) while patients with partial/complete response will undergo Wertheim's hysterectomy.
  6. After surgery Pathological evaluation will include T, N, M, histological type, Lymphovascular invasion (LVI), Perineural invasion (PNI), Depth of Tumor Invasion, Extra nodal extension (ENE), Grade, (next generation sequencing (NGS)- Mutation Analysis.
  7. Post operative external pelvic irradiation was given according to Sedlis criteria in node negative, margin negative, parametria negative cases.
  8. Follow up Evaluation was done at 1, 3 \& 6 months by clinical examination, Biopsy for any recurrence and Imaging (CECT or MRI pelvis) at 6 months. Follow up was continued every 3 months thereof.
Being tested
Neoadjuvant chemotherapy
Keywords
cancer, cervix, neoadjuvant chemotherapy, predictors
Medical subject headings
Uterine Cervical Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neoadjuvant chemotherapyDrug

    Also called Paclitaxel and Carboplatin

    doublet of taxane and carboplatin

Study groups in NCT05384366
Study groupRoleWhat they receive
Neoadjuvant chemotherapyOtherPatients receiving neoadjuvant paclitaxel 175mg/m2 and carboplatin (AUC5) at three weekly interval by intravenous route
Receives: Drug: Neoadjuvant chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Response

    Response to intervention by RACIST criteria 1.1

    Measured: 21 days after completion of third cycles

  2. Pathological response

    Pathological response after evaluation of surgical specimen and pathological staging

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2022
  2. Study start1 Aug 2020
  3. Primary completion31 Mar 2022
  4. Study completion31 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05384366
Sponsor's protocol ID
NeoCx
Status last verified
May 2022
First submitted
16 May 2022
Last updated
20 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: On request

Publications

  • 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.

    PubMed 12743137

  • 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.

    PubMed 23640393

  • 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.

    PubMed 24431655

  • 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.

    PubMed 25992238

  • 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.

    PubMed 9345358

  • 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.

    PubMed 24825458

  • 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.

    PubMed 28187089

  • 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.

    PubMed 27678502

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Neoadjuvant chemotherapy in people with Cervix Cancer and Cervical Cancer, run by Banaras Hindu University at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Response (time frame: 21 days after completion of third cycles). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05384366, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2022.

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