Neoplasms

Symptoms and General Pathology

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasm Metastasis

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gerard Adams

The researchers propose that it may be corpus invasion, rather than tumour volume per se, which is one of the important determinants of ultimate outcome in cervix cancer. The aim of the proposed prospective, multicentre study, is to confirm the results of our retrospective studies, specifically that corpus invasion or tumour volume or both contribute important prognostic information over and above that provided by the currently used International Federation of Gynecology and Obstetrics (FIGO) staging system. A successful outcome would have important implications for the staging, and management as well as the biologic understanding of the behaviour of cervical cancer.

This will be a prospective, multicentre, prognostic factor, follow-up study. The study is designed to be as simple as possible: newly diagnosed cervical cancer patients will have key prognostic variables collected at baseline. The treatment received will be documented at the end of treatment and patients will then be followed for first relapse and survival.

Registration of a patient on this study can be undertaken after EUA, biopsy confirmed diagnosis, anatomic staging diagram and MRI have been done and before any treatment has commenced.

Treatment must be curative in intent (termed radical therapy) but otherwise can be at the discretion of the investigator. Radical hysterectomy alone, hysterectomy followed by adjuvant radiotherapy, radical chemo-radiotherapy or radical radiotherapy will be allowed. Details of the planned and given treatment regimen will be recorded.

All patients will have the following trial data documented at the time of registration:

* Age
* ECOG performance status
* smoking status
* date of histological diagnosis
* histologic type and features
* presenting haemoglobin
* standard FIGO staging
* maximum clinical tumour diameter measured at EUA
* detailed staging diagram drawn at EUA
* nodal status (by surgical pathology or CT or MRI or both and PET if available)
* date of MRI
* MRI tumour diameters
* presence or absence of corpus invasion on MRI
* planned treatment details

All patients will be assessed pre-treatment, immediately following treatment and will be followed up for local control and survival at yearly intervals from the date of registration.

It is intended to collect follow up information on all patients until one year after the final patient is registered on study.

Magnetic Resonance Imaging (MRI) Staging of Cervix Cancer

Prospective Study to Determine the Relationships Between Survival and FIGO Stage, Tumour Volume and Corpus Invasion in Cervical Cancer

Peter MacCallum Cancer Centre, Australia

Trans Tasman Radiation Oncology Group

Rebecca Montgomery

Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Taxane

Tubulin Modulators

Antimitotic Agents

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

Neoadjuvant chemotherapy

Manoj Pandey, MS, PhD

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).

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.

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

Neoadjuvant Chemotherapy in Cervical Cancer

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

Response to intervention by RACIST criteria 1.1

Pathological response after evaluation of surgical specimen and pathological staging

Banaras Hindu University

Professor

Immune System Diseases

Body Weight

Carcinoma, Squamous Cell

Hypersensitivity

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Anti-Infective Agents

Fluorodeoxyglucose F18

Deoxyglucose

Radiopharmaceuticals

The 18F-FDG-PET will be performed 8 weeks following completion of brachytherapy (date of inclusion)

18F-FDG-PET

GOLFIER François, MD, PhD

Rationale: The benefit-risk ratio of surgery following concomitant radiochemotherapy and brachytherapy remains to be defined in cervical squamous-cell carcinoma (SCC) treatment. Scarce studies evaluated the interest of 18F-FDG-PET and MRI in the assessment of response to treatment before surgery. A positive predictive value of 75% was found in a small study making 18F-FDG-PET a promising tool to assess tumor response and guide surgical approach. Diffusion-weighted MRI was also described as an early and sensitive indicator in other diseases.

Objectives: The main objective of this study is to evaluate the sensitivity of 18F-FDG-PET in the assessment of cervical cancer response to radiochemotherapy and brachytherapy. Secondary objectives focus on 18F-FDG-PET specificity and likehood ratios as well as diffusion-weighted MRI diagnostic performances.

Method: We will conduct a prospective cohort study of 148 women with a stage IB to IIB2 cervical SCC recruited over 2.5 years in 24 centers in France. Each patient will undergo a 18F-FDG-PET and a diffusion-weighted MRI before surgery and 8 weeks after completion of the brachytherapy. The total follow-up duration (study participation) of patients will be 11 weeks : inclusion after completion of radiochemotherapy and brachytherapy, 8 weeks until 18F-FDG-PET and diffusion-weighted MRI, and 3 weeks until surgery.

Expected results: 18F-FDG-PET and diffusion-weighted MRI could constitute a reliable tool to assess response to radiochemotherapy and brachytherapy in cervical SCC treatment. If so it could improve clinical practices and be helpful to decide whether the patient needs surgery or not after radiochemotherapy and brachytherapy.

Diagnostic Performance of 18F-FDG-PET and Diffusion-weighted MRI in the Assessment of Stage IB to IIB2 Cervical Squamous-cell Carcinoma Response to Concomitant Radiochemotherapy and Brachytherapy

A centralized review will be carried out by 2 independant reviewers, additionally to the initial interpretation. The gold-standard to evaluate tumoral response to radiochemotherapy and brachytherapy will be the anatomopathologic analysis of the hysterectomy piece after surgery. The18F-FDG-PET will be performed 8 weeks following completion of brachytherapy (date of inclusion)and surgery will be performed within 3 weeks after the 18F-FDG-PET.

Hospices Civils de Lyon

Recurrence

Immune Checkpoint Inhibitors

Drug: Cadonilimab 10mg/kg,every 3 weeks,IV infusion

Drug: Nab paclitaxel

≤260mg/m2,every 3 weeks,IV infusion

Cadonilimab 10mg/kg,every 3 weeks,IV infusion

Cadonilimab

Nab paclitaxel ≤260mg/m2,every 3 weeks,IV infusion

Nab paclitaxel

hui Wang, PHD

bairong xia, PHD

Ge Lou, PHD

This is a phase II trial of combination therapy of cadonilimab(Bispecific Anti-PD-1/CTLA-4 Antibody) plus nab-Paclitaxel in patients with recurrent or metastatic cervical cancer that had failed PD-1/PD-L1 blockade therapy. As a bispecific antibody against PD-1 and CTLA-4, cardonirimab can not only induce the production of a large number of T cells in the early stage of immune response by antagonizing CTLA-4, but also block PD-1 and PD-L1/L2 combination. Thereby restoring the killing function of T cells to tumor cells and reducing the exhaustion of T cells.The hypothesis is the combination of cadonilimab and nab-Paclitaxel will overcome PD-1/PD-L1 blockade-resistance to enhance the response of patients with persistant, recurrent or metastatic cervical cancer.

Primary objective:

Objective response rate for cadonilimab in combination with nab-paclitaxel in the treatment of persistent, recurrent, or metastatic cervical cancer previously treated with immune checkpoint inhibitors.

Secondary objective:

To evaluate duration of response (DoR) and disease control rate (DCR) of cardinirimab combined with nab-paclitaxel in the treatment of persistent, recurrent or metastatic cervical cancer who have previously received immune checkpoint inhibitor therapy based on RECIST v1.1 and time to response (TTR).

To evaluate the progression-free survival (PFS) and overall survival (OS) of patients with persistent, recurrent or metastatic cervical cancer who had previously received immune checkpoint inhibitor therapy with cardonilimab combined with nab-paclitaxel.

To evaluate the safety and tolerability of this combination therapy.

Exploratory objective:

To search for potential indicators in tumor tissue or peripheral blood of subjects that can predict the efficacy of cardonirimab combined with nab-paclitaxel.

cadonilimab 10mg/kg Q3W and nab-paclitaxel ≤260mg/m2 Q3W

Cadonilimab Plus Nab -Paclitaxel for Patients With Recurrent, or Metastatic Cervical Cancer Resistant to Immune Checkpoint Inhibitors

A Single-arm, Open-label, Multicenter Phase II Study of Cadonilimab Combined With Nab -Paclitaxel in Patients With Persistent, Recurrent, or Metastatic Cervical Cancer Previously Treated With Immune Checkpoint Inhibitors

Evaluate the correlation between therapeutic effect and immune cells (T cells, B cells, myeloid and other subgroups), TCR, HPV, cytokines in tumor tissue and peripheral blood, and analyze the immune-resistant microenvironment characteristics, Dynamic changes of immune microenvironment before and after treatment with cadonilimab combined with nab-paclitaxel. Genomic profile predicts efficacy of cadonilimab combined with Nab-Paclitaxel.

To evaluate the clinical activity (as assessed by objective response rate \[ORR\]) of specific Cadonilimab and Nab-Paclitaxel combination.

To evaluate the clinical activity (as assessed by duration of response (DoR)) of Cadonilimab and Nab-Paclitaxel combinations. DOR: length of time tumor continues to respond to the treatment.

Defined as the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease.

Defined as the time from randomization to the date of the first confirmed documented response (CR or PR)

To evaluate the clinical activity (as assessed by progression-free survival \[PFS\]) of Cadonilimab and Nab-Paclitaxel combinations. PFS: Time from treatment initiation to the first documented disease progression per response evaluation criteria in solid tumors (RECIST) 1.1 as assessed by local site or death, whichever occurs first.

To evaluate the clinical activity (as assessed by overall survival \[OS\]) of Cadonilimab and Nab-Paclitaxel combinations. OS: Time from treatment initiation to death due to any cause.

To evaluate the safety and tolerability of Cadonilimab and Nab-Paclitaxel combination:

Number of Participants Experiencing Adverse Events (AEs) according to NCI CTCAE Version 5.0.

EORTC QLQ-C30 was a questionnaire which included 30 questions that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Scores are transformed to a range of 0 to 100 using a standard EORTC algorithm. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/quality of life (QoL) represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problem.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Magnetic Resonance Imaging (MRI) Staging of Cervix Cancer	NCT00193934	Cancer of the U...		18 Years -	Trans Tasman Radiation Oncology Group
Neoadjuvant Chemotherapy in Cervical Cancer	NCT05384366	Cervix Cancer Cervical Cancer Cancer of the U...	Neoadjuvant che...	18 Years - 100 Years	Banaras Hindu University
Diagnostic Performance of 18F-FDG-PET and Diffusion-weighted MRI in the Assessment of Stage IB to IIB2 Cervical Squamous-cell Carcinoma Response to Concomitant Radiochemotherapy and Brachytherapy	NCT01663753	Cancer of the U...	18F-FDG-PET	18 Years -	Hospices Civils de Lyon
Cadonilimab Plus Nab -Paclitaxel for Patients With Recurrent, or Metastatic Cervical Cancer Resistant to Immune Checkpoint Inhibitors	NCT05824494	Uterine Cervica... Cancer of Cervi... Cervical Cancer Cervical Neopla... Uterine Cervica... Cancer of the U...	Cadonilimab Nab paclitaxel	18 Years - 75 Years	Women's Hospital School Of Medicine Zhejiang University

Spots Global Cancer Trial Database for cancer of the uterine cervix