Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

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

The inclusion criteria were: (1) pathologically confirmed CC; (2) FIGO stage IB-IIA according to the result of physical examination and imaging; (3) abdominal MRI was performed within three weeks before surgery. Exclusion criteria were: (1) accompanied with other tumors. (2) with chronic infectious disease. (3) incomplete clinical data.

no intervention

Yang Sun, PHD

Yang Sun

This study aims to develop a diagnostic nomogram based on clinical factors with the prediction values of vaginal invasion in cervical cancer to optimize the treatment plan and surgical procedures.

Vaginal invasion is a crucial index participant in cervical cancer tumor staging and prognosis prediction. However, the roles of vaginal invasion are overlooked in the literature, compared with those of lymph node metastasis and parametrial invasion. As far as we know, this study is novel to construct a nomogram to predict the probability of pathologic vaginal invasion occurrence.

A Diagnostic Nomogram for Predicting Vaginal Invasion in Cervical Cancer

Establish a New Noninvasive Diagnostic Model Based on Clinical Indicators to Evaluate the Vaginal Invasion in Cervical Cancer Patients

100 cervical cancer patients who underwent radical hysterectomy (RH) with bilateral pelvic lymphadenectomy were pathologically assessed for vaginal invasion. The primary outcome is vaginal invasion or no-vaginal invasion. Pathological vaginal invasion is defined as cervix tumor disruption of the vaginal wall.

Fujian Cancer Hospital

Rare Diseases

Prostatic Neoplasms

Vaginal Neoplasms

Endometrial Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Vaginal Diseases

Vaginal Cancer

(complete blood count, platelet count, renal function evaluation)

Biological investigations

Bone marrow is one of the organs at risk of complications during irradiation due to its radiosensitivity. Hematopoietic toxicity remains one of the main toxicities during irradiation of pelvic lymph node areas, especially when concomitant chemotherapy is used, volume of bone marrow irradiated is large and dose to the bone marrow is high. There is a lack of prospective studies and comparative trials to customize the constraints according to the presence or absence of chemotherapy and correlated to the patient's bone marrow potential. This multicentric and prospective study conducted by Strasbourg Europe Cancerology Institute aims to evaluate hematological toxicity (anemia, thrombocytopenia, leukopenia) in patients treated with pelvic irradiation for prostate, rectum, anal canal, endometrium, cervix cancer or vaginal cancer. One hundred patients will be included in the study, including patients treated with exclusive radiotherapy, radiochemotherapy, or radiohormonal therapy. The primary objective is to quantify the relationship between acute hematological toxicity and delivered doses and irradiated volumes in pelvic bone marrow for pelvic cancers. Hematological toxicity will be measured by weekly blood count during radiotherapy and at one month and three months after the end of radiotherapy. Secondary endpoints are the evaluation of viral, bacterial and fungal infections during and for three months following radiotherapy, as well as the evaluation of the impact of radiation-induced hematological toxicity on the administration of chemotherapy for the concerned patients. The aim of this study is to improve and optimize radiotherapy if a dose limit or volume constraint is imposed by the results of the study.

Patients will be identified as potentially eligible for inclusion once radiotherapy has been decided upon at the multidisciplinary consultation meeting. During the radiotherapy consultation, the study will be offered to the patient if they also meet the other inclusion criteria. As soon as the consent is signed and before the first radiotherapy session, a first biological check-up including a blood count and renal function will be performed. This biological investigation will serve as a reference.

During the dosimetric computer-tomography scan for radiotherapy, bony structures will be delineated, iliac bones, lower pelvis, femoral heads, lumbosacral spine and entire pelvis.

Dosimetry will be performed in the same way whether patients are included in the study or not, they will receive between 25Gy in 5 fractions and 78Gy in 39 fractions, depending on the primary tumor. The dose volume histograms will be received.

During treatment, patients will have a weekly blood test starting from the second week of treatment. At one months and three months after the end of the radiotherapy, patients will be seen in consultation and will also have a blood test.

Effect of Irradiation Doses < 10 Gy and of Irradiated Bone Volume on the Variation of Blood Elements of the Complete Blood Count During and After Pelvic Irradiation

* Haemoglobin
* Platelets
* Neutrophils
* Lymphocytes

Institut de cancérologie Strasbourg Europe

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Adenocarcinoma

Respiratory Tract Infections

Adenocarcinoma in Situ

Carcinoma in Situ

Cervical Intraepithelial Neoplasia

Anti-Infective Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Proflavine

Anti-Infective Agents, Local

Before participant's cold knife cone biopsy (CKC), topical application of 0.01% proflavine solution applied to cervix. HRME probe applied to cervix and high-resolution images obtained. Participant undergoes cervical biopsies of any abnormal areas noted with colposcopy and/or HRME. Immediately following the CKC, the removed surgical specimen evaluated. Proflavine reapplied to surgical specimen and repeat evaluation with HRME performed and high-resolution images obtained.

0.01% proflavine solution topically applied to cervix before high-resolution microendoscopy (HRME) imaging.

in-vivo high-resolution microendoscopy (HRME) images of cervical adenocarcinoma in situ (AIS) performed immediately prior to conization.

High-Resolution Microendoscopy (HRME) Imaging

Kathleen Schmeler, MD

The goal of this clinical research study is to learn if it is possible to get high-resolution microendoscopy (HRME) images of AIS tissue and/or tissue from microinvasive carcinoma right before a biopsy of the cervix. Researchers also want to learn if HRME images can show the difference between cancerous tissue and normal cervical tissue.

If you agree to take part in this study, after you are in the operating room and under general anesthesia, proflavine hemisulfate solution (contrast dye) will be applied to the cervix. Images will be collected with the probe from the HRME device. The HRME probe is a long thin tube with a camera at the tip. This probe will be applied to the cervix and images obtained. These images will be used for research. This should add about 10 minutes to the total time you are in the operating room.

There will be no change to the planned standard-of-care colposcopy and biopsy.

Follow-Up:

A member of the research team will call you within 30 days after the procedure to ask how you are feeling and if you are having any symptoms. This call should last about 5 minutes.

Length of Study:

Your active participation in this study will be over after the biopsy.

This is an investigational study. The goal of this clinical research study is to learn if it is possible to get high-resolution microendoscopy (HRME) images of AIS tissue and/or tissue from microinvasive carcinoma right before a biopsy of the cervix. Researchers also want to learn if HRME images can show the difference between cancerous tissue and normal cervical tissue.

Use of High-Resolution Microendoscopy (HRME) in Patients With Adenocarcinoma In-Situ (AIS) of the Cervix

Methodology determined feasible if in-vivo HRME images are acquired in if 18 of the 20 participants enrolled in the study.

AIS finding tabulated by the CKC specimen results as determined by pathology. Concordance of HRME images taken ex-vivo estimated with pathology findings with a 90% credible, assuming a beta (1.8, 0.2) prior distribution for the concordance.

M.D. Anderson Cancer Center

Before participant's cold knife cone biopsy (CKC), topical application of 0.01% proflavine solution applied to cervix. HRME probe applied to cervix and high-resolution images obtained. Participant undergoes cervical biopsies of any abnormal areas noted with colposcopy and/or HRME. Immediately following the CKC, the removed surgical specimen evaluated. Proflavine reapplied to surgical specimen and repeat evaluation with HRME performed and high-resolution images obtained.

Proflavine: 0.01% proflavine solution topically applied to cervix before high-resolution microendoscopy (HRME) imaging.

High-Resolution Microendoscopy (HRME) Imaging: in-vivo high-resolution microendoscopy (HRME) images of cervical adenocarcinoma in situ (AIS) performed immediately prior to conization.

High-Resolution Microendoscopy (HRME)

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Due to low accrual no analysis conducted.

Dr. Kathleen M. Schmeler, MD

Due to not meeting enrollment requirements, data was not collected

Feasibility of Acquiring In-vivo High-Resolution Microendoscopy (HRME) Images of Cervix Prior to Conization

Due to low accrual, no specimens were collected to be analyzed

Adenocarcinoma In-Situ (AIS) Distinguished From Normal Cervical Tissue Using High-Resolution Microendoscopy (HRME) Imaging

Overall Study

Antineoplastic Agents

Etoposide

Cisplatin

Etoposide phosphate

Enzyme Inhibitors

The cycle dose should be strictly controlled according to the experimental design. The order of administration is as follows: Karelizumab → Cisplatin → Etoposide (with an interval of at least 30 minutes)

Karelizumab：200 mg，ivgtt，D1，q3w； Cisplatin：75 mg/m2，ivgtt，D1，q3w； Etoposide：100 mg/m2，ivgtt，D1\~3，q3w

Karelizumab combined with etoposide and cisplatin

He Hai Xin

This study is a single arm, exploratory clinical study aimed at evaluating the efficacy and safety of karelizumab combined with etoposide and cisplatin in the neoadjuvant treatment of neuroendocrine cervix carcinoma.

This study is a single arm, exploratory clinical study aimed at evaluating the efficacy and safety of karelizumab combined with etoposide and cisplatin in the neoadjuvant treatment of neuroendocrine cervix carcinoma.Following this, patients achieving complete or partial response will proceed to radical surgery and adjuvant therapy, while those with stable or progressive disease, or considered unsuitable for surgery by gynecological oncologists, will transfer to concurrent chemoradiotherapy.

Neoadjuvant Treatment of Neuroendocrine Cervix Carcinomar With Camrelizumab Combined With Etoposide and Cisplatin

A Single Arm, Exploratory Clinical Study on the Neoadjuvant Treatment of Neuroendocrine Cervix Carcinoma With Camrelizumab Combined With Etoposide and Cisplatin

The proportion of participants achieving Complete Response (CR), Partial Response (PR) or Stable Disease (SD) according to RECIST1.1.

The period between the onset of treatment and the observation of disease progression or the occurrence of death for any reason.

After radical treatment (complete surgical removal of the tumor), there is no time for the disease to recur.

The proportion of patients who have survived for one and three years after comprehensive treatment.

The probability that the patient's disease will not continue to worsen within one and three years.

The proportion of patients with reduced or stable tumors within 1 and 3 years.

The ratio of the number of cases with adverse events to the total number of cases available for evaluation.

Antibodies

Antibodies, Monoclonal

Paclitaxel

Carboplatin

Pembrolizumab

Albumin-Bound Paclitaxel

Immunomodulating Agents

Immunoglobulins

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Standard Chemotherapy will be adminitred in 2 independant cohorts: Endometrial carcinoma or Cervix Carcinoma

Experimental double combination \[Standard Chemotherapy +NP137\] will be administred in 2 independant cohorts: Endometrial carcinoma or Cervix Carcinoma

Experimental double combination \[Pembrolizumab +NP137\] will be administred in 2 independant cohorts: Endometrial carcinoma or Cervix Carcinoma

Experimental triple combination \[Pembrolizumab+ Standard Chemotherapy + NP137\] will be administred in 2 independant cohorts: Endometrial carcinoma or Cervix Carcinoma

Recombinant humanized IgG1 monoclonal antibody against Netrin 1. NP137 will be administred IV, Q3W until disease progression, unacceptable toxicity, death, patient or physician decision to withdraw, pregnancy or SMPC guidance, whichever occurs first.

NP137

Humanised monoclonal anti-programmed cell death-1 (PD-1) antibody will be administred in IV Q3W. A maximum 35 cycles of treatments (approximately 2 years) with pembrolizumab can be administered to patients.

Standard Chemotherapy agent will be administred IV, Q3W, up to 6 cycles of treatment.

Ray-Coquard Isabelle, MD, PhD

Elsa KALBACHER, MD

Coriolan LEBRETON, MD

Florence JOLY, MD

Jean-David FUMET, MD

Cyril ABDEDDAIM, MD

Isabelle RAY COQUARD, MD,PhD

Magali PROVANSAL, MD

Michel FABBRO, MD

Jean-Sébastien FRENEL, MD

Frederic SELLE, MD

Alexandre DE MOURA, MD

Alexandra LEARY, MD

Jerome ALEXANDRE, MD, PhD

Thibault DE LA MOTTE ROUGE, MD

Laurence GLADIEFF, MD

The aim of this study is to investigate the safety and the clinical activities of NP137 when combined with pembrolizumab and/or chemotherapies in patients with advanced/metastatic gynecological cancers (2 types: endometrial carcinoma and cervix carcinoma).

The prognosis of patients with locally advanced/metastatic uterine (endometrial or cervical) cancer progressing/relapsing after at least one prior systemic treatment remains poor. The development of new innovative anti-tumor drug candidates as single agent or in combination with chemotherapy or check point inhibitors is needed.

NP137 is a first-in-class humanized monoclonal antibody targeting specifically and selectively Netrin-1. By blocking Netrin-1, NP137 is capable of restoring apoptosis in tumor cells in vitro and in vivo, leading to therapeutic activity in various animal cancer models.

Dependence receptors inhibitor such as NP137 might be a novel choice to improve the clinical outcomes of these patients.

The herein proposed study will be a multicenter, open-label, randomized, Phase I/II trial with:

A safety run in part to assess the safety of the therapeutic combinations for the first 6 patients enrolled in each of the therapeutic combinations independently of the tumor type. According to safety rules, these therapeutic combinations will be investigated or not in the Phase II part.

A Phase II part will be then conducted using an adaptive Bayesian approach allowing to quickly stop treatment cohorts without evidence of efficacy and/or select promising treatment cohorts. The Phase II part will be initiated with a preliminary step to assess the clinical activity of the proposed therapeutic combinations in 2 tumor types before proceeding to the activation of extension phase II part of the study. For each cohorts, clinical activity will be assessed through by sequential statistical analysis at specific timepoints.

GYNecological Cancers Treated With NETrin mAbs in Combination With Chemotherapy and /or Pembrolizumab

A Randomized, Multicenter, Open Label, Phase I/II Study to Evaluate the Safety, Clinical and Biological Activity of a Humanized Monoclonal Antibody Targeting Netrin-1 (NP137) in Combination With Carboplatin Plus Paclitaxel and/or Pembrolizumab in Patients With Locally Advanced/Metastatic Endometrial Carcinoma or Cervix Carcinoma Progressing/Relapsing After at Least One Prior Systemic Chemotherapy.

Any pre-definied toxicities graded by using NCI CTCAE Version 5.0 and assessed by the investigator to be possibly, probably, or definitely related to study treatments administration during the safety run in period

Rate of patients with CR or PR as per RECIST 1.1

The proportion of evaluable patients with an objective response according to RECIST 1.1.

Time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression or death is documented,

Time from first study drug intake until disease progression or death, whichever occurs first

Time from the first day of study treatment to the date of death due to any cause.

The best response designation between the date of the first study treatment and the date of objectively documented progression or the date of subsequent anti-cancer therapy

Area under the concentration-time curve from time zero to the last sample with the quantifiable concentration

Area under the concentration-time curve from time zero to infinity corresponding to the definite integral of a curve that describes the variation of a drug concentration in blood plasma as a function of time (drug exposure in plasma)

Clearance: volume of plasma from which NP137 is completely removed per unit time.

Terminal elimination half-life: time required for the amount of NP137 in the body to decrease by half.

Merck Sharp & Dohme LLC

Centre Leon Berard

NETRIS Pharma

Metronidazole

Anti-Bacterial Agents

Antiprotozoal Agents

Antiparasitic Agents

Participants in the intervention arm received 1gm (2 suppositories) of metronidazole per rectum 30 minutes before radiotherapy for every other radiotherapy session with two rest days of Saturday and Sunday. The standard radiotherapy regimen for advanced cancer of the cervix composed of two phases of radiotherapy was used; phase 1 was tele-therapy via parallel-opposed portals from Co-60 radiation source, with a total dose of 50 Gy given in 25 fractions of 2 Gy/day for five weeks. The patients were then given a break of 1-4 weeks before getting the second phase of treatment. Phase 2 was brachy-therapy from a Cs-137 source, whereby a single dose of 30Gy was delivered at point A at a rate of 2.55 Gy/ hour for 7 hours and 50 minutes, via a uterine Tandem and two vaginal Ovoids.

Participants in the control arm received 500mg (two suppositories) of paracetamol as a placebo on similar days. This was in addition to the standard radiotherapy administration in two phases as described above.

Metronidazole was added to the standard radiotherapy that is routinely used.

Radiotherapy plus metronidazole

Peter Kibuuka, MBChB

Mike Kagawa, MMed

Anthony Okoth, MMed

Joseph Kigula-Mugambe, MMed

The objective of the study was to determine whether there was a difference in the effectiveness of Radiotherapy alone compared with Radiotherapy plus Metronidazole in the treatment of women with advanced cancer of the cervix in Mulago hospital. It was a randomized controlled trial composed of 38 women altogether, with one group composed of randomly selected women with advanced cancer of the cervix treated with radiotherapy alone and the other group composed of similar women but treated with radiotherapy and metronidazole.

Methods A double blinded placebo controlled trial was used to determine the efficacy and safety of metronidazole as an adjunct to radiotherapy compared to radiotherapy alone for the treatment of anemic patients with advanced cancer of the cervix as measured by clinical response.

The unit of randomization was a woman with cancer of the cervix from stage IIIB to IVB and hemoglobin level of 12g/dl or less. The ones who consented to the study were enrolled and randomized to either the radiotherapy and metronidazole (RT+MX) or the radiotherapy and placebo (RT) arms.

The study was conducted in both the Department of Radiotherapy and the Department of Obstetrics and Gynecology of Mulago hospital, Kampala, Uganda.

Women eligible for inclusion in the study were those with cancer of the cervix who had histologically proven stage IIB to IVB, fit for radiotherapy and an Hb of 12g/dl or less. Women taking metronidazole treatment for other reasons other than radio-sensitization and those with a history of neuropathy or with hypersensitivity to metronidazole were excluded.

A randomization code was generated by an independent statistician who did not participate in the study nor visit the study site. The randomization code was then placed in an opaque and sealed envelope and sent a copy to the pharmacist in the study centre so that he got to know what to put in each envelope for study participants. The envelopes were kept by the study pharmacist who dispensed the drugs. The code was to be broken when the principal investigator felt that the blinded treatment was harmful to the patient, either because of the side effects or failure to respond in which case he would urgently notify the data safety and review board with the view of breaking the code for that particular patient.

The total number of study participants was 40. In view of the need for equal numbers at equally spaced points in the sequence of the study, random permuted blocks of four patients each were used. Letter A was used for Radiotherapy \& Metronidazole (RT+MX) and B for Radiotherapy alone (RT) assignment. The blocks were as follows:

AABB - block number 1 ABBA- block number 2 BBAA - block number 3 ABAB - block number 4 BAAB - block number 5 BABA - block number 6 Treatment modalities included radiotherapy administration plus Metronidazole or paracetamol administration. Radiotherapy administration was in two phases using tele-therapy and brachy-therapy. The first phase was tele-therapy via parallel-opposed portals (half the dose in antero-posterior and the other half in the postero-anterior direction) from Co-60 radiation source, with a total dose of 50 Gy given in 25 fractions of 2 Gy/day (Monday to Friday and weekend rest) for five weeks. The patients were then given a break of 1-4 weeks before getting the second phase of treatment. The second phase was brachy-therapy from a Cs-137 source, whereby a single dose of 30Gy was delivered at point A at a rate of 2.55 Gy/ hour for 7 hours and 50 minutes, via a uterine Tandem and two vaginal Ovoids. In case of severe vaginal stenosis during the first phase, a cylindrical applicator would be used.

Participants in the study arm received 1gm (two suppositories) of metronidazole per rectum 30 minutes before radiotherapy for every other radiotherapy session and it was omitted in the two rest days of Saturday and Sunday. Participants in the control arm received 500mg (two suppositories) of paracetamol as a placebo on similar days. The study was conducted during day time.

The metronidazole and paracetamol suppositories looked identical in colour, smell and shape. Although the packaging was similar it had different labels. They were therefore dispensed when ready to use and out of the packaging and each patient got two suppositories in a session.

Subjective assessment of the clinical symptom response among study patients was done every day on the Mulago radiotherapy department grading system for cancer response (Kigula-Mugambe 2001). Response was graded into 4 grades as follows; Grade 1: Complete response (no tumour clinically seen and all the symptoms and signs have subsided) Grade 2: Partial response (at least 50% of the symptoms and signs have subsided) Grade 3: No response (symptoms and signs have not changed with treatment) Grade 4: Disease progression with treatment (symptoms and signs at the end of treatment worse than the beginning of treatment) Measurement of tumour regression was done by a trans-abdominal real time B-mode ultrasound scan which was both at the beginning and the end of tele-therapy. It was aimed at measuring the widest transverse diameter, the thickness and length of the cervical tumour. The tumour volume was then computed by the ultrasound machine. Patients needed to have a full urinary bladder before ultrasound was done. Local tumour response was measured using the formula below Local tumour response = {(Volume A - Volume B)/Volume A} X 100% Where A was the tumour volume at the beginning of treatment and B was the tumour volume after the course of teletherapy.

Complications were subjectively assessed using the Franco-Italian (Fl) glossary for radiotherapy complications of March 1990 as follows:

Grade 0: No complication. Grade 1: Mild complications (minor symptoms/signs not requiring treatment or requiring simple outpatient treatment) Grade 2; Moderate complications (these require hospitalization but without a treatment break).

Grade 3: Severe complication (distressing complications which lead to a treatment break and or life threatening morbidity e.g. fistula formation) Grade 4: Complications leading to death/fatal

Radiotherapy + Metronidazole vs Radiotherapy Alone In Improving Treatment Outcomes in Advanced Cervical Cancer in Uganda

A Randomized Clinical Trial of Radiotherapy and Metronidazole Versus Radiotherapy Alone in Anaemic Patients With Advanced Cervical Cancer In Mulago

To determine the efficacy and safety of metronidazole as an adjunct to radiotherapy in anemic patients with advanced cervical cancer in improving treatment outcomes in Mulago Hospital, Kampala, Uganda.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Diagnostic Nomogram for Predicting Vaginal Invasion in Cervical Cancer	NCT06039982	Cervix Carcinom...	no intervention	18 Years - 80 Years	Fujian Cancer Hospital
Effect of Irradiation Doses < 10 Gy and of Irradiated Bone Volume on the Variation of Blood Elements of the Complete Blood Count During and After Pelvic Irradiation	NCT04626466	Prostate Carcin... Rectum Carcinom... Anal Canal Carc... Endometrium Car... Cervix Carcinom... Radiotherapy Vaginal Cancer	Biological inve...	18 Years - 79 Years	Institut de cancérologie Strasbourg Europe
Use of High-Resolution Microendoscopy (HRME) in Patients With Adenocarcinoma In-Situ (AIS) of the Cervix	NCT02206048	Cervix Carcinom...	Proflavine High-Resolution...	21 Years - 64 Years	M.D. Anderson Cancer Center
Neoadjuvant Treatment of Neuroendocrine Cervix Carcinomar With Camrelizumab Combined With Etoposide and Cisplatin	NCT05910177	Carcinoma Cervix Carcinom...	Karelizumab com...	18 Years - 75 Years	Fujian Cancer Hospital
GYNecological Cancers Treated With NETrin mAbs in Combination With Chemotherapy and /or Pembrolizumab	NCT04652076	Endometrial Car... Cervix Carcinom...	NP137 Pembrolizumab Paclitaxel Carboplatin	18 Years -	NETRIS Pharma
Radiotherapy + Metronidazole vs Radiotherapy Alone In Improving Treatment Outcomes in Advanced Cervical Cancer in Uganda	NCT01937650	Cervix Carcinom...	Radiotherapy pl...	18 Years -	Makerere University

Spots Global Cancer Trial Database for cervix carcinoma