Neoplasms

All Conditions

Rare Diseases

Carcinosarcoma

Mixed Tumor, Mullerian

Adenoma, Pleomorphic

Neoplasms by Histologic Type

Sarcoma

Neoplasms, Connective and Soft Tissue

Malignant Mixed Mullerian Tumor

Ovarian Carcinosarcoma

Uterine Carcinosarcoma

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Trabectedin

Antineoplastic Agents, Alkylating

Alkylating Agents

Trabectedin will be infused at the dose of 1.3 mg/m2 as a 3- hour iv infusion every 3 weeks via a central venous catheter.

Domenica Lorusso, Prof.

Multicenter phase II study on trabectedin in patients advanced uterine and ovarian carcinosarcoma. Patients will receive trabectedin until disease progression or unacceptable toxicity. Disease response evaluation will be assessed every 9 weeks.

This is a Phase II, multi-centre, single arm study aiming at evaluating efficacy and toxicity of Trabectedin in a population of advanced or recurrent ovarian and uterine carcinosarcoma.

Trabectedin will be infused at the dose of 1.3 mg/m2 as a 3- hour iv infusion every 3 weeks via a central venous catheter.

Trial On Trabectedin In The Treatment Of Advanced Uterine And Ovarian Carcinosarcoma (CS)

Phase II Trial On Trabectedin In The Treatment Of Advanced Uterine And Ovarian Carcinosarcoma (CS)

The primary endpoint of this study is to evaluate the activity of trabectedin in terms of the objective response rate (ORR) in patients with advanced uterine and ovarian carcinosarcoma.

the diagnosis of progression will be assessed by radiological criteria; CA 125 increases alone (GCIG criteria of progression) will not be considered as progression of disease without a radiological confirmation of progression

Incidence of adverse events, according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) v 4.03.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Digestive System Diseases

Behaviors and Mental Disorders

Skin and Connective Tissue Diseases

Carcinoma

Adenocarcinoma

Ovarian Neoplasms

Gastrointestinal Stromal Tumors

Neuroendocrine Tumors

Glioma

Aggression

Adenocarcinoma, Clear Cell

Fibromatosis, Aggressive

Carcinoma, Small Cell

Seminoma

Adenocarcinoma, Mucinous

Cystadenocarcinoma

Sex Cord-Gonadal Stromal Tumors

Neoplasms, Germ Cell and Embryonal

Fibroma

Neoplasms, Glandular and Epithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Nerve Tissue

Neoplasms, Connective Tissue

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Germinoma

Neoplasms, Cystic, Mucinous, and Serous

Neoplasms, Fibrous Tissue

Ovarian Cancer

Neuroendocrine Tumor

Germ Cells Tumors

Adenocarcinoma of the Appendix

Desmoid Tumor

Ovarian Germ Cell Tumor

Testicular Seminoma

Nonseminomatous Germ Cell Tumor

Neuroepithelioma

Central Nervous System Germinoma

On-site surveillance by a hospital physician

Post-cancer surveillance (including biological, clinical and imaging exams depending on the condition)

Oncological Follow-up

Laurence ROTSAERT

Fanny BEN OUNE

Guillaume BONNET

Mathieu BOONE, MD

François GERNIER

Nicolas PENEL, MD

PENEL Nicolas, MD, PhD

This is a multicenter, interventional, randomized study among adult patients recently diagnosed with a rare tumor (\<12 months). The study will aim to compare compliance with the personalized post-treatment surveillance plan, established for each patient according to national guidelines, when the surveillance is conducted in person by a hospital-based physician (control arm) or remotely by a trained nurse (experimental arm).

The primary objective of this study is to compare 2-year compliance with the personalized post-treatment surveillance plan between the two arms.

The secondary objectives are to compare between the two arms :

* Long-term compliance (5-year follow-up)
* Use of care
* Oncological events and their management
* Supportive care needs

The exploratory objectives are to :

* Evaluate the costs in terms of medical transportation
* Evaluate and compare patients' satisfaction and psychological well-being (in terms of anxiety/depression)
* Evaluate the homogeneity of the impact of the intervention according to covariates (gender, tumor pathology, occupational status, and center)
* Evaluate the reasons for recruitment failures

Assessment of Compliance With Monitoring Conducted by a Physician in Person or by a Nurse in Remote Monitoring

Randomized Phase II Trial Evaluating Compliance With Monitoring Conducted Either by a Hospital-based Physician in Person or by a Nurse in Remote Monitoring

Medical transport includes light medical vehicles and ambulances

Salary mass mobilized from a hospital perspective in both arms

Patients will answer a satisfaction survey (French Version of the Princess Margaret Hospital Satisfaction With Doctor) at different points of the study depending on their pathology

Patient reported outcomes will be evaluated using the Hospital Anxiety and Depression Scale (HADS) questionnaire at different points of the study depending on their pathology.

The questionnaire consists of a list of questions to determine the level of anxiety and depression experienced by the patients. Each question is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression:

A score equal to or less than 7 indicates no symptoms, A score of 8 - 10 indicates a questionable symptoms, A score of 11 and above confirms of the presence of anxiety and/or depression symptoms.

In each investigating site, a screening log will be completed to find out the reasons for recruitment failures

Compliance is defined by completion of all scheduled examinations (telephone contact, biological, clinical examination and imaging examination) with a margin of + or - 30 days from the scheduled date

Rate of patients lost to follow-up or quitting the surveillance program

* number of physical consultations at the investigator site
* number of emergency room visits for oncological reasons
* number of extra-hospital consultations for oncological reasons

Occurence and type of oncological event : relapse/progression.

The management of oncological events will be evaluated according to three criteria :

* completion of an oncological surgery
* implementation of a treatment by radiotherapy
* implementation of a systemic therapy such as chemotherapy

Time from randomization to first oncological event (progression/relapse) or death from any cause.

Time from randomization to death from any cause

Support care needs include :

* algology consultation
* nutrition/diet consultation
* psycho-oncology consultation
* social worker consultation
* job retention consultation

Canceropôle Nord Ouest

Groupement Interrégional de Recherche Clinique et d'Innovation

Centre Oscar Lambret

Carcinoma, Ovarian Epithelial

Cystadenocarcinoma, Serous

Fallopian Tube Neoplasms

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Fallopian Tube Diseases

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Liz-Anne Lewsley

Debbie Rai

Axel Walther

James Brenton

Anne Petrie

Charlie Gourley

Lauren McNamara

Ros Glasspool

Patricia Roxburgh

Rowan Miller

Michelle Lockley

Jeremy Tai

Susana Banerjee

Eleanor Holmes

Laura TOOKMAN

Richard Edmondson

Andrew Clamp

Marcia Hall

Iain McNeish

In BriTROC-2, up to 250 women with a confirmed diagnosis of high-grade serous/high-grade endometrioid or carcinosarcoma will be eligible for full consent (Part 2) and registration to BriTROC-2 and will be followed prospectively until first relapse. Women with presumed newly-diagnosed high-grade serous carcinoma of the ovary, fallopian tube or peritoneum can be approached for consent to Part 1 (screening consent) of BriTROC-2 prior to formal diagnosis.

The aim of this study is to acquire tumour material at diagnosis and relapse, whole blood for genomic analysis and plasma for ctDNA. This study will also isolate single cells and establish organoid cultures from ascites/peritoneal washings.

BriTROC-2 is a sample collection study from women with ovarian cancer from the point of diagnosis to the time of disease relapse.

Ovarian cancer has a poor prognosis. The large majority of patients with ovarian cancer will relapse and ultimately develop fatal chemotherapy resistance. Although there is a wealth of information regarding the molecular basis of ovarian cancer at diagnosis, very little is known about the drivers of treatment resistance (both intrinsic and acquired) and the processes that are active at relapse. This research requires sequential collection of tumour material for women throughout the course of their disease.

This multicentre study will collect tumour samples, ascites (fluid within the abdomen) and blood from women with newly diagnosed ovarian cancer and follow these women through to relapse of their disease. The samples collected will be used to look at patterns within the tumour to identify those that are able to predict response to chemotherapy and outcome. Assays and models will be developed that can look at the process that are active in a tumour at time of sample acquisition. This will give clues into the mechanisms that drive treatment resistance. Ultimately this research aims to guide future treatment options for women with ovarian cancer.

Recruitment will be over 3 years and this study will be conducted at sites with expertise in managing ovarian cancer and the ability to carry out the appropriate sample collection and collect high quality clinical data.

This study is the second collaborative project within the UK to collect samples from women with ovarian cancer. The success of the first study, BriTROC-1, demonstrated the feasibility of sample collection from women with relapsed ovarian cancer. The methods and frameworks established in BriTROC-1 will be used for BriTROC-2.

1. Tumour tissue from diagnosis from 250 patients
2. Whole blood samples from 250 patients
3. Plasma blood samples from 250 patients
4. Serum blood samples from 250 patients
5. Ascites/pleural fluid/peritoneal washings

Longitudinal Sample Collection to Investigate Adaptation and Evolution of Ovarian High-grade Serous Carcinoma

To obtain tumour biopsies from 250 women with newly diagnosed high-grade carcinoma of the ovary, fallopian tube or peritoneum - all those with high-grade serous carcinoma (HGSC), high-grade endometrioid carcinoma or carcinosarcoma will be eligible.

To obtain whole blood for germline DNA isolation.

To obtain plasma for ctDNA at diagnosis, during first line chemotherapy, at follow up and at the time of relapse.

To obtain ascites/washings from women at diagnosis and at the time of relapse.

Ovarian Cancer Action

Project Manager

Symptoms and General Pathology

Recurrence

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Tubulin Modulators

Antimitotic Agents

Galunisertib

IV day 1 Carboplatin AUC 6\* over 1 hour (or 5\* if no prior radiation therapy)

Kathleen Moore, MD

This is a Phase 1 B feasibility trial with Galunsertib, a TGFβ inhibitor, in combination with carboplatin/paclitaxel in patients with newly diagnosed, persistent or recurrent carcinosarcoma of the uterus or ovary. The objective of the study is to determine whether this drug combination is safe for this patient population and to see if it is effective in shrinking cancers, keeping them from growing or helping patients live longer.

Patients who consent to this study will receive treatment for four 28 day cycles unless they are unable to continue study treatment due to toxicity or disease progression. Paclitaxel and carboplatin will be given intravenously on day 1 of each cycle and galunisertib in pill form on days 4-17. No medicine will be given on days 17-28 of each cycle. Patients may have the option of continuing treatment with the study drug if they complete the 4 cycles the study requires. Subjects will receive tests and procedures that are part of regular cancer care as well as those required for the purposes of the study. Blood samples will be taken to monitor the level of study drug in the blood. Patients will have the option of allowing blood and tumor samples to be used for future research.

The patient population for this study only applies to females.

Paclitaxel/Carboplatin + Galunisertib for Patients With Carcinosarcoma of the Uterus or Ovary

Feasibility IB Trial of Paclitaxel/Carboplatin + Galunisertib (a Small Molecule Inhibitor of the Kinase Domain of Type 1 TGF-B Receptor) in Patients With Newly Diagnosed, Persistent or Recurrent Carcinosarcoma of the Uterus or Ovary

To determine the feasibility of delivering 4 cycles of carboplatin/paclitaxel (CT) in combination with galunisertib (GB) to patients with gynecologic carcinosarcoma

To determine the frequency and severity of adverse events as assessed by the CTCAE v4

To determine the PFS of patients receiving drug combination

Galunisertib serum concentration levels will be tested

To determine the overall survival of patients receiving drug combination

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trial On Trabectedin In The Treatment Of Advanced Uterine And Ovarian Carcinosarcoma (CS)	NCT02993705	Carcinosarcoma,... Carcinosarcomas...	Trabectedin	18 Years - 100 Years	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Assessment of Compliance With Monitoring Conducted by a Physician in Person or by a Nurse in Remote Monitoring	NCT05500391	Stage I Testicu... Stage I Testicu... Gastrointestina... Ovarian Germ Ce... Adenocarcinoma,... Borderline Ovar... Sex Cord-Stroma... Mucinous Adenoc... Carcinoma, Smal... Carcinosarcoma,... Serous Tumor of... Glioma Neuroendocrine ... Aggressive Fibr...	Oncological Fol...	18 Years -	Centre Oscar Lambret
Longitudinal Sample Collection to Investigate Adaptation and Evolution of Ovarian High-grade Serous Carcinoma	NCT05537844	Ovarian Cancer High Grade Sero... Carcinosarcoma,... Fallopian Tube ... Primary Periton... BRCA1 Mutation BRCA2 Mutation		16 Years -	Cancer Research UK, Glasgow
Longitudinal Sample Collection to Investigate Adaptation and Evolution of Ovarian High-grade Serous Carcinoma	NCT05537844	Ovarian Cancer High Grade Sero... Carcinosarcoma,... Fallopian Tube ... Primary Periton... BRCA1 Mutation BRCA2 Mutation		16 Years -	Cancer Research UK, Glasgow
Paclitaxel/Carboplatin + Galunisertib for Patients With Carcinosarcoma of the Uterus or Ovary	NCT03206177	Carcinosarcoma,...	Galunisertib Paclitaxel Carboplatin	18 Years - 99 Years	University of Oklahoma

Spots Global Cancer Trial Database for carcinosarcoma, ovarian