Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

this group will benefit from standard care including: one surgical consultation, one anesthesia consultation, surgery followed by 2-4 days of hospitalization and most of the time 3 post-operative consultations (M1, M6, M12) during the first operative year

Preoperative and postoperative protocols will be applied for optimizing same-day discharge. Gynaecologists, anaesthetists, and nursing staff will work as a team. A specific anesthesia consultation will focus on ambulatory surgery management. A geriatric evaluation will be offered to women over 70 years old with a score ≤14 according to G8 screening tool. A dietetic evaluation will be offered to women with BMI ≥ 35. A nursing consultation will be offered, as patient and their family preparation prior to ambulatory surgery is important.

total hysterectomy and bilateral salpingo-oophorectomy with or without lymphadenectomy

ambulatory surgery

standard surgery

Geoffroy CANLORBE, MD

Lise ROCHAIX, MD PHD

To date, cost-utility, safety, and feasibility of ambulatory surgery versus traditional pathway in the management of endometrial cancer have never been prospectively assessed.

The investigators hypothesize that ambulatory surgery versus standard pathway in the management of endometrial cancer is both safe, feasible and may impact on patient health-related quality of life.

The main objective of the study is to assess the cost-utility of ambulatory surgery versus standard pathway in the management of endometrial cancer.

A total of 252 consecutive, eligible, consenting patients with a low- and intermediate-risk early stage endometrial cancer will be enrolled from various clinical practice sites within France and patient will randomly be assigned to one of the two surgical management pathways: ambulatory pathway versus standard pathway.

In developed countries, endometrial cancer is the fourth most common cancer in women. Women with stage I disease, representing almost 75% of cases, have an overall survival of 95%. According to the European guidelines, the standard surgical approach for stage I endometrial cancer consists of laparoscopic total hysterectomy and bilateral salpingo-oophorectomy with or without lymphadenectomy. For patients undergoing laparoscopic surgery for gynecological malignancies, most studies report average hospital stays of 1 day after surgery. Patients are commonly kept in the hospital following surgery for pain and nausea control, prolonged bladder catheterization, and observation for surgical complications. However, some recent retrospective studies show that same-day discharge for patients undergoing laparoscopic staging for endometrial cancer is feasible and safe, despite associated comorbidities (i.e., obesity, hypertension, diabetes) related to endometrial cancer.

A short hospital stay decreases the risk of exposure to hospital infections, causes less disruption to the patient's personal life, results in potential cost savings for patients and relatives, as well as for hospitals, and there is positive feedback regarding the social environment of patients as they return rapidly to daily activities and work.

To date, safety, feasibility and cost-utility of ambulatory surgery versus traditional pathway in the management of endometrial cancer have never been prospectively assessed.

The investigators hypothesize that ambulatory surgery versus standard pathway in the management of endometrial cancer is both safe, feasible and may impact on patient health-related quality of life.

The main objective of the study is to assess the cost-utility of ambulatory surgery versus standard pathway in the management of endometrial cancer.

A total of 252 consecutive, eligible, consenting patients with a low, intermediate- and high-risk early stage endometrial cancer will be enrolled from various clinical practice sites within France and patient will randomly be assigned to one of the two surgical management pathways: ambulatory pathway versus standard pathway.

Preoperative and postoperative protocols (including geriatric and dietetic evaluation, and anesthesia and nursing consultation) will be applied for optimizing same-day discharge of patients randomly assigned to ambulatory surgery.

Data will be collected in conjunction with usual care visit, 1 month after initial surgery.

The economic evaluation will closely follow the 2011 French National Authority for Health (HAS) economic evaluation guidelines and the evaluation proposal will have three complementary parts with a full cooperation between those involved in the evaluation:

First, the economic evaluation will focus on evaluating the cost-utility profile of ambulatory surgery in endometrial cancer in France. This economic evaluation will include a micro-costing study to estimate by direct observation the cost of resources used during the ambulatory pathway, and the total cost of patients' care in each group. The primary endpoint will be the incremental cost-utility ratio using the 30-day health related quality of life. It will be calculated for both groups using health-related quality of life (HRQoL) scores from the EQ-5D and converted to utility scores using French weights. QALYs will be computed at 30 days (primary analysis) using both mortality and HRQoL scores.

Second, the investigators will perform an analysis of patients' and professionals' preferences about ambulatory care pathways. These preferences will be analyzed in depth, using both surveys and recent tools developed in experimental economics. Health care professionals' views and preferences will be collected, using questionnaires and face-to-face interviews both at the beginning of the study (M0). Patients' preferences will be assessed using a Discrete Choice Experiment (DCE) method, which is increasingly used in health economics.

Third, a thorough analysis of the ethical and inequality aspects tied to the development of ambulatory surgery in endometrial cancer will be developed, following the methodological guidance issued in 2013 by the HAS. Special emphasis will be laid on equity issues in the measurement of patients' benefits, using a capability approach (ICECAP-A questionnaire).

Finally, another secondary objective will be to assess the safety and feasibility of ambulatory surgery versus traditional pathway in the management of endometrial cancer, and to validate biomarkers of high risk of nodal involvement in a translational study (complementary budget will be asked for this part).

a multicentre, prospective and randomised study

Cost-utility of Ambulatory Surgery in the Management of Endometrial Cancer(AMBU-ENDO)

Cost-utility, Safety and Feasibility of Ambulatory Surgery Versus Traditional Pathway in the Management of Endometrial Cancer: a Multicentre, Prospective and Randomised Study

It will be calculated for both groups using health-related quality of life (HRQoL) scores from the EQ-5D and converted to utility scores using French weights

QALYs will be computed using both mortality and HRQoL scores

Rate of women requiring overnight admission

Patients' preferences will be assessed using a Discrete Choice Experiment (DCE) method, which is increasingly used in health economics.

Ecole d'econmie de Paris (PSE)-Hospinnomics

Université Montpellier

Université de Rennes 1 CREM CNRS UMR 6211

Assistance Publique - Hôpitaux de Paris

Rare Diseases

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Antineoplastic Agents

Temozolomide

Antineoplastic Agents, Alkylating

Alkylating Agents

Standard surgery plus intraoperative radiotherapy (20-30 Gy) followed by radiochemotherapy (EBRT: 60 Gy, 75 mg/m2/d temozolomide) and adjuvant chemotherapy with 150-200 mg/m2/d temozolomide per cycle (5/28 days).

Standard surgery followed by radiochemotherapy (EBRT: 60 Gy, 75 mg/m2/d temozolomide) and adjuvant chemotherapy with 150-200 mg/m2/d temozolomide per cycle (5/28 days).

Standard surgery

Dose to applicator surface: 20-30 Gy; Carl Zeiss INTRABEAM System. IORT with a surface dose of 30 Gy is recommended.Should the proximity to any risk structure not allow to apply 30 Gy, a dose reduction by up to 10 Gy (resulting in a surface dose of 20 Gy) is allowed.

Intraoperative radiotherapy

EBRT to 60 Gy plus 75 mg/m2/d temozolomide

Radiochemotherapy

Adjuvant chemotherapy with 150-200 mg/m2/d temozolomide per cycle (5/28 days).

Martina Nesper-Brock, PhD

Clinical Trial Office UMM

Lisa Arnold

Norissa Honea, RN, PhD

Kris A. Smith, MD

Michael Lawton, MD

Beth A Chiappetta, RN, BSN, CCRP

Abhishek Solanki, MD

Louise A Purcell, MS ANP-C CCRN-CMC

Michael Schulder, MD

Tamika A Wong, MPH

John A. Boockvar, MD

Joseph Brunetti

Christopher P Cifarelli, MD, PhD, FAANS, FACS

Douglas Guedes de Castro, MD

Rodrigo Hanriot, MD

Kevin Petrecca, MD, PhD

Kevin Petrecca, MD

Luis Souhami, MD

Chengkai Zhang

Zhan Xue, MD

Sabine Schill, PhD

Klaus H Kahl, MD

Susanne Runewitz

Peter Vajkoczy, MD

Julia Onken, MD

Axel Madlung, MD

Oliver Sorge, MD

Anna Hedwig Müller

Studienzentrale Strahlentherapie

Michael Ehmann, MD

Nima Etminan, MD

Carmen Kessel, PhD

Stephanie E Combs, MD

Ulrike Arzbach

Oliver Ganslandt, MD

Marc Münter, MD

Mareike Schultes

Marc Piroth, MD

Ik Jae Lee, MD

Montserrat Ventura Bujalance

Ferran Guedea, MD, PhD

Sonia Garcia Cabezas, MD

Juan Solivera Vela, MD

Frank A. Giordano, MD

INTRAGO II resembles a multicentric, prospective, randomized, 2-arm, open-label clinical phase III trial which tests if the median progression-free survival (PFS) of patients with newly diagnosed glioblastoma multiforme (GBM) can be improved by the addition of intraoperative radiotherapy (IORT) to standard radiochemotherapy.

Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma Multiforme

A Multicenter Randomized Phase III Trial on INTraoperative RAdiotherapy in Newly Diagnosed GliOblastoma Multiforme (INTRAGO II)

Determined according to modified Response Assessment in Neuro-Oncology (RANO) criteria and serial perfusion imaging

Determined by serial contrast-enhanced MRI scans using modified RANO criteria and serial perfusion imaging

Median overall survival of patients \<65 vs. ≥ 65 years

Progression-free survival of patients \<65 vs. ≥ 65 years; determined according to modified RANO criteria and serial perfusion imaging

Median overall survival of patients with KPS 80-100% vs. 60-70%

Progression-free survival of patients with KPS 80-100% vs. 60-70%; determined according to modified RANO criteria and serial perfusion imaging

Thickness of anticipated T1-Gd-enhancing (remaining) tumor margin as per the discretion of the surgeon (margin ≥0.5 cm or multiple spots of residual tumor within the cavity vs. \<0.5 cm)

Thickness of anticipated T1-Gd-enhancing (remaining) tumor margin as per the discretion of the surgeon (margin ≥0.5 cm or multiple spots of residual tumor within the cavity vs. \<0.5 cm); determined according to modified RANO criteria and serial perfusion imaging

Early postoperative MRI scans must be used to determine the extent of resection (EoR). The EoR is given as sum of all maximum diameters of residual lesions in cm. OS will be calculated for the following groups:

* Max Diameter group 0: 0 cm (no residual tumor)
* Max Diameter group 1: \>0 to ≤1.5 cm (cumulative if multiple residual lesions)
* Max Diameter group 2: \>1.5 cm (cumulative if multiple residual lesions)

Early postoperative MRI scans must be used to determine the extent of resection (EoR). The EoR is given as sum of all maximum diameters of residual lesions in cm. PFS will be determined according to modified RANO criteria and serial perfusion imaging for the following groups:

* Max Diameter group 0: 0 cm (no residual tumor)
* Max Diameter group 1: \>0 to ≤1.5 cm (cumulative if multiple residual lesions)
* Max Diameter group 2: \>1.5 cm (cumulative if multiple residual lesions)

OS in patients with promoter methylation vs. no promoter methylation

PFS in patients with promoter methylation vs. no promoter methylation; determined according to modified RANO criteria and serial perfusion imaging

Assessed by European Organization for Research and Treatment (EORTC)- Quality of Life Questionnaires (QLQ C30/BN20)

Change in functional outcomes as measured by BI from its baseline value.

Assessed by regular neurological examinations and serial MRI scans

Carl Zeiss Meditec AG

University of California, Los Angeles

Universitätsmedizin Mannheim

PI (Chair)

Carcinoma

Carcinoma, Squamous Cell

Neoplasms, Squamous Cell

Oral Squamous Cell Carcinoma

IPH2201 followed by standard surgery and standard postsurgical adjuvant therapy

The first 6 patients will receive IPH2201, IV, at a dose of 4 mg/kg q2w x 4. Subsequent patients will be treated at a dose of 10 mg/kg q2w x 4.

IPH2201

After the end of treatment with IPH2201, according to standard recommendations in the relevant country .

Standard Surgery

After the standard surgery, according to standard recommendations in the relevant country

Postsurgical Adjuvant Therapy

The primary objective of this open label Phase Ib/II trial is to evaluate the clinical and pharmacological activity of IPH2201 as a single-agent in treatment-naïve pre-operative patients with operable Squamous Cell Carcinoma of the Oral Cavity .

43 patients are planned to be enrolled. The first 6 patients will receive IPH2201 at a dose of 4 mg/kg q2w x 4. Subsequent patients will be treated at a dose of 10 mg/kg q2w x 4. Standard loco-regional treatment with surgery followed by adjuvant therapy will be initiated after the last administration of IPH2201.

Efficacy Study of Pre-operative IPH2201 in Patients With Squamous Cell Carcinoma of the Oral Cavity

Open Label Single Arm Phase Ib-II Study of Pre-operative IPH2201 in Patients With Locally Advanced Resectable Squamous Cell Carcinoma of the Oral Cavity

Innate Pharma

Digestive System Diseases

Symptoms and General Pathology

Wounds and Injuries

Colorectal Neoplasms

Hyperthermia

Fever

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Anti-Infective Agents

Mitomycins

Mitomycin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

ARM A: Prophylactic surgery plus HIPEC CO2 performed with mitomycin

ARM B: Standard surgey without HIPEC CO2 The arm B is with standard surgery without HIPEC CO2

Prophylactic surgery plus HIPEC CO2 performed with mitomycin

HIPEC CO2 surgery

Fabio Pacelli, MD

Chiara Gerardi

Michele Simone

Giovanni Ciaccio

Maurizio Rizzo

Giovanni Ferrari, MD

Luigi Boni

Carmine Antropoli

Francesco Corcione

Antonino Agrusa

Roberto Persiani

Luigi Bonavina

Francesca Bazzocchi

This is a phase III randomized, multicenter study with two different arm:

* experimental: prophylactic surgery plus HIPEC CO2 performed with mitomycin
* comparator: standard surgery Adjuvant treatment after surgery is mandatory except for documented cases of non-eligibility.

Patient will be randomized in a 1:1 ratio. Randomization will be done during surgery if the total resection of tumour will be reached and will use a stratification procedure based on center

This is a phase III randomized, multicenter study with two different arm:

* experimental: prophylactic surgery plus HIPEC CO2 performed with mitomycin
* comparator: standard surgery Adjuvant treatment after surgery is mandatory except for documented cases of non-eligibility.

Patient will be randomized in a 1:1 ratio. Randomization will be done during surgery if the total resection of tumour will be reached and will use a stratification procedure based on center

The HIPEC CO2 regimen will be as reported below:

mitomycin: (total dose of 35 mg/mq, physiologic solution 0.9%) administrated 50% at time 0 from start of HIPEC CO2 treatment (17.5 mg/mq), 25% (8.8 mg/mq) after 30 minutes and the last dose 25% after 60 minutes. Recommended temperature for HIPEC treatment is 41-42 °C for 90 minutes.

Adjuvant treatment consists of a 6 months chemotherapy after surgery. It is possible to choose between Oxaliplatin, Capecitabine (XELOX) or Oxaliplatin, Fluorouracil, Leucovorin (FOLFOX-4) Patients affected by CRC at high risk of developing peritoneal carcinomatosis will be randomized in the study.

This is a phase III randomized, multicenter study with two different arm:

* experimental: prophylactic surgery plus HIPEC CO2 performed with mitomycin
* comparator: standard surgery

Prophylactic Surgery Plus HIPEC With CO2 in Patients Affected by Colorectal Carcinoma. CHECK Study.

Prophylactic Surgery Plus Hyperthermic Intraperitoneal Chemotherapy (HIPEC CO2) Versus Standard Surgery in Colorectal Carcinoma at High Risk Peritoneal Carcinomatosis. Short and Long-term Outcomes. CHECK STUDY

The primary efficacy endpoint is LRFS defined as the time from randomization to the date of first local relapse, peritoneal carcinomatosis or death for any cause, whichever comes first.

Disease Free Survival (DFS) DFS is defined as the time from randomization to the date of first local relapse, distant relapse, peritoneal carcinomatosis or death for any cause, whichever comes first.

OS is defined as the time from randomization to death for any cause.

evaluated during and after surgery, graded according to the NCI-CTAE version 4.03 for AE related to chemotherapy and according to Clavien Dindo for surgery complications

patients performing the adjuvant chemotherapy

Mario Negri Institute for Pharmacological Research

Stomach Neoplasms

Stomach Diseases

Stomach Cancer

Cisplatin

Prophylactic surgery plus HIPEC CO2 performed with mitomycin and cisplatin

Prophylactic surgery plus HIPEC CO2 performed with mitomycin and cisplatin v

Surgery plus HIPEC CO2

Andrea Di Giorgio, MD

Erica Rulli

Alberto Biondi

Andrea Di Giorgio

This is a phase III randomized, multicenter study with two different arm:

* experimental: prophylactic surgery plus HIPEC CO2 performed with mitomycin and cisplatin
* comparator: standard surgery

Adjuvant treatment after surgery is mandatory except for documented cases of non-eligibility in both arms.

Patient will be randomized in a 1:1 ratio. Randomization will be performed during surgery if the total resection of tumor will be reached according to center and neoadjuvant chemotherapy as stratification variables.

This is a phase III randomized, multicenter study with two different arm:

* experimental: prophylactic surgery plus HIPEC CO2 performed with mitomycin and cisplatin
* comparator: standard surgery Adjuvant treatment after surgery is mandatory except for documented cases of non-eligibility.

Patient will be randomized in a 1:1 ratio. Randomization will be performed during surgery if the total resection of tumor will be reached according to center and neoadjuvant chemotherapy as stratification variables.

The primary objective of the study is to compare the efficacy of prophylactic surgery (radical gastric resection, appendectomy, round ligament of the liver resection and bilateral adnexectomy) plus HIPEC CO2 versus standard surgery in terms of disease free survival (DFS).

Patients affected by gastric carcinoma at high risk of developing peritoneal carcinomatosis will be randomized in this study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cost-utility of Ambulatory Surgery in the Management of Endometrial Cancer(AMBU-ENDO)	NCT03580421	Endometrial Can... Endometrial Can...	ambulatory surg... standard surger...	18 Years -	Assistance Publique - Hôpitaux de Paris
Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma Multiforme	NCT02685605	Glioblastoma	Standard surger... Intraoperative ... Radiochemothera... Temozolomide	18 Years - 80 Years	Universitätsmedizin Mannheim
Efficacy Study of Pre-operative IPH2201 in Patients With Squamous Cell Carcinoma of the Oral Cavity	NCT02331875	Squamous Cell C...	IPH2201 Standard Surger... Postsurgical Ad...	18 Years -	Innate Pharma
Prophylactic Surgery Plus HIPEC With CO2 in Patients Affected by Colorectal Carcinoma. CHECK Study.	NCT03914820	Colorectal Neop...	HIPEC CO2 surge... Standard surger... Mitomycin	18 Years - 75 Years	Mario Negri Institute for Pharmacological Research
Prophylactic Surgery Plus HIPEC With CO2 in Patients Affected by Gastric Carcinoma.GOETH Study	NCT03917173	Stomach Neoplas...	Surgery plus HI... Standard surger...	18 Years - 75 Years	Mario Negri Institute for Pharmacological Research

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