Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Endometrial Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Endocrine Gland Neoplasms

Ovarian Diseases

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

Endocrine System Diseases

Gonadal Disorders

Uterine Neoplasms

Uterine Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Female patients with high grade OC (advanced or metastatic epithelial ovarian, fallopian tube and primary peritoneal cancer):

* with newly diagnosed FIGO stage IIb-IV OC who are starting systemic treatment, independent of the treatment intention (adjuvant/curative or palliative) or
* with recurrent/relapsed disease, who received any previous systemic anti-tumor treatment and who are now starting their systemic treatment for first recurrent/relapsed disease.

Female patients with locally advanced and inoperable or metastatic EC (FIGO stage III-IV) who are starting systemic first-line therapy.

Physician's choice according to patient's needs.

iOMEDICO AG

Thomas Decker, Prof.Dr.

Ingolf Juhasz-Böss, Prof.Dr.

Elmar Stickeler, Prof.Dr.

Dirk Watermann, Prof.Dr.

Anja Welt, Dr.

Achim Wöckel, Prof.Dr.

The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study, a tumor registry platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with advanced or metastatic ovarian cancer (OC) or advanced or metastatic endometrial cancer (EC) in Germany.

SMARAGD is a national, prospective, open-label, longitudinal, non-interventional multicenter cohort study (tumour registry platform) to describe treatment in routine clinical practice of ovarian, fallopian tube, primary peritoneal and endometrial patients in routine care in Germany.

The registry will follow patients for up to three years with the aim to identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented.

Health-related quality of life (HRQoL) will be evaluated for up to three years.

All patients will be asked to give additional informed consent agreeing that their routinely collected tumor samples could be used for further translational research. For the decentralized biobank, pathological samples will remain with the local pathologist until scientific translational question arise. Future translational research projects that will develop during the project will be described in detail in independent research proposal and reviewed by an ethics committee.

Registry Platform Ovarian and Endometrial Cancer

SMARAGD - Clinical Research Platform on Ovarian, Fallopian Tube, Primary Peritoneal and Endometrial Cancer Treatment and Outcomes

Documentation of anamnestic data and therapy sequences.

Documentation of response rates per line of treatment.

Documentation of progression-free survival per line of treatment.

Documentation of overall survival per line of treatment.

Functional Assessment of Cancer Therapy - Ovarian (FACT-O), a 39 item questionnaire covering Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being and Ovarian Cancer Subscale

Functional Assessment of Cancer Therapy - Endometrial (FACT-En), a 43 item questionnaire covering Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being and Endometrial Cancer Subscale

Symptoms and General Pathology

Neoplasm Metastasis

Recurrence

Neoplastic Processes

Antineoplastic Agents

All Drugs and Chemicals

Dermatologic Agents

Immune Checkpoint Inhibitors

Immunomodulating Agents

Coal Tar

Keratolytic Agents

Group A (drug treatment group) : Chemotherapy drugs ,targeted drugs or Immune checkpoint inhibitors are taken throughout the body or a combination of these drugs according to clinical needs is performed when necessary.

IFRT, IMRT or SBRT is applied. Irradiation techniques and doses can be selected based on the previous experience of each center, but all patients enrolled within the center need to be consistent.

Drug therapy is the same as group A; IFRT is the same as group B.

Chemotherapy drugs ,targeted drugs or Immune checkpoint inhibitors are taken throughout the body or a combination of these drugs according to clinical needs is performed when necessary.

chemotherapy, targeted therapeutics, immunotherapy

IFRT（involving field radiotherapy） IMRT （ intensity modulated radiation therapy） SBRT （stereotactic body radiation therapy）

IFRT, IMRT or SBRT

Zi Liu, Ph.d

Jing Zhang, M.D

zi liu, Ph.D

In this study, The researchers sought to explore the efficacy and safety of involving field radiotherapy in the oligo-metastatic/recurrent/refractory ovarian cancer patients among different groups which include drug therapy alone, radiotherapy alone, and drug therapy plus radiotherapy by inviting clinical multi-center participation.

The recurrent or refractory ovarian cancer tends to recur repeatedly at increasingly short intervals, making treatment more and more difficult.Patients often have limited physical capacity to undergo repeated systematic treatment. Currently, NCCN（ national comprehensive cancer network ）guidelines recommend palliative radiotherapy in patients with local recurrence of ovarian cancer. With the progress of IMRT（ intensity modulated radiation therapy ）, SBRT ( stereotactic body radiation therapy ) and other radiotherapy technologies, better local tumor control rate can also be achieved, while minimizing the damage to surrounding normal tissues. In this study, the patients will be divided into groups according to their wishes: group A (drug therapy alone), group B (radiotherapy alone), and group C (radiotherapy plus drug therapy).The researchers sought to explore the the efficacy and safety of involving field radiotherapy in the oligo-metastatic/recurrent/refractory ovarian cancer patients in different groups after treatment by inviting multiple centers to participate in the study.

Group A (drug treatment group) : Patients accept paclitaxel + platinum or paclitaxel single drug chemotherapy of which paclitaxel 135-175mg/m2, carboplatin AUC=5, cisplatin 40-60mg/m2. The treatment should be repeated every 3 weeks. Other second-line and third-line chemotherapy regimens (dose is not specified) are also allowed. Targeted, immunological or PARPi drugs can be added based on pathological and genetic test results until disease progression, unacceptable toxicity or informed consent withdrawal. Group B (radiotherapy group): IFRT, IMRT or SBRT is applied. Radiotherapy regimen: Involving field PGTV 60Gy-70Gy, 2-3Gy/f,5 times/week. External irradiation techniques and doses can be selected based on the previous experience of each center, but all patients enrolled within the center need to be consistent. Group C (radiotherapy + drug group) : IFRT is the same as group B;Drug therapy: same as group A.

Efficacy and Safety of Involving Field Radiotherapy in the Oligo-lesions(Metastasis/Recurrent/Refractory) of Ovarian Cancer

LC will be measured from the start date of treatment until the date of progressive of the target lesion

PFS is defined as the time from first day of treatment until the first date of either objective disease progression or death due to any cause

OS is defined as the time from first day of treatment until the date of death due to any cause or the deadline for the study

Rate of acute and late adverse reactions associated with radiotherapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Registry Platform Ovarian and Endometrial Cancer	NCT05129969	Ovarian Cancer Endometrial Can... Ovary Neoplasm Endometrial Neo... Carcinoma, Ovar... Carcinoma Neoplasm, Ovari...	Physician's cho...	18 Years -	iOMEDICO AG
Registry Platform Ovarian and Endometrial Cancer	NCT05129969	Ovarian Cancer Endometrial Can... Ovary Neoplasm Endometrial Neo... Carcinoma, Ovar... Carcinoma Neoplasm, Ovari...	Physician's cho...	18 Years -	iOMEDICO AG
Efficacy and Safety of Involving Field Radiotherapy in the Oligo-lesions(Metastasis/Recurrent/Refractory) of Ovarian Cancer	NCT05059782	Ovarian Cancer Neoplasm, Ovari... Ovarian Neoplas... Ovary Neoplasms Neoplasm, Ovary Neoplasms, Ovar... Ovary Neoplasm Neoplasms, Ovar... Ovary Cancer Cancer, Ovarian... Cancers, Ovary Ovary Cancers Cancer, Ovarian Cancers, Ovaria... Ovarian Cancers Cancer of Ovary Cancer of the O...	chemotherapy, t... IFRT, IMRT or S...	18 Years -	Health Science Center of Xi'an Jiaotong University

Spots Global Cancer Trial Database for neoplasm, ovarian