Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Rectal Neoplasms

Recurrence

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Transanal Minimally Invasive Surgery (TAMIS) or Transanal Endoscopic Operation (TEO)

TAMIS

Diego de Frutos, MD

Alberto Herreros de Tejada, MD, PhD

Álvaro Terán

Felipe Ramos

Pedro Rosón, MD

Eduardo Albeniz, MD, PhD

David Barquero

Oscar Nogales

Jose Carlos Marín

Eduardo Albéniz, MD, PhD

A multicenter non-inferiority randomized clinical trial to compare Endoscopic treatment (ESD) and Minimally Invasive Laparoscopic Local Surgical Treatment (TAMIS or TEO) for early rectal neoplastic lesions (adenoma \& T1CRC) Primary aim: To compare the long-term local recurrence rate (12 months after the procedure)

Secondary aims:

Compare en-bloq resection rate, R0 resection, time per procedure, short-term recurrence rate, safety (rate of complications), morbidity and cost-effectiveness analyses.

A multicenter non-inferiority randomized clinical trial is proposed to compare two types of treatment for early rectal neoplastic lesions. Study arms:

1. Endoscopic treatment: Endoscopic Submucosal Dissection (ESD)
2. Minimally invasive laparoscopic local surgical treatment: Transanal Minimally Invasive Surgery (TAMIS) or Transanal Endoscopic Operation (TEO).

Aims:

Primary aim: To compare the long-term local recurrence rate (12 months after the procedure) of rectal lesions after ESD vs Surgical treatment (TAMIS/TEO).

Secondary aims: Both arms of the study are compared according to other efficacy-related variables (en-bloq resection rate, R0 resection, time per procedure, short-term recurrence rate \[6 months\]), safety (rate of complications), morbidity (comparing different specific indexes: Wexner index, EQ-5L-5D, etc) and cost-effectiveness analyses (QALY).

Inclusion criteria:

* Patients older than 18 y/o
* Non-pedunculated rectal lesions (sessile 0-Is or flat 0-II) greater than 20 mm in diameter.
* The edges of the lesion should be more than 3 cm from the external anal margin and up to 14 cm from it.
* Circumferential involvement \<50%

Exclusion criteria:

* Patients who refuse to participate.
* Diagnosis of inflammatory bowel disease with rectal involvement.
* Pregnant.
* Anorectal fibrosis due to previous anorectal surgery.
* Lateral Spreading Lesions (LST classification) Granular Homogeneous type
* Lesions greater than 50 mm when there is suspicion of advanced histology (Kudo Vi superficial pattern).
* Rectal lesions of any size with high suspicion of deep submucosal invasion or locoregional lymph node involvement, either in the diagnostic colonoscopy (Kudo Vn crypt pattern, NICE 3 pattern, Sano IIIB pattern) or by complementary imaging tests (rectal EUS/Pelvic MRI)
* Existence of synchronous colorectal lesions that require other surgical treatment in any case.

N-size estimation:

Assuming a global rate of long-term local recurrence in rectal lesions treated by TAMIS/TEO or ESD of 2.5% (using the data available in the medical literature), considering a non-inferiority limit of 10%, power of 80% (Beta error 0.2, alpha error 0.05) and assuming a loss of patients during the follow-up around 10%, 34 patients per group are required.

Follow-up and Information collect:

The follow-up will be of 1 year from the date of the intervention and the visits in which the information to be analyzed will be collected are adjusted to the usual clinical practice.

The data would be registered using the on-line database system for medical research RedCap.

Other information:

The entire protocol of this study has been approved by de Ethical Committee on Clinical Research of the Puerta de Hierro University Hospital.

The study counts with a Civil Responsibility Insurance policy.

Endoscopic Submucosal Dissection vs Local Laparoscopic Surgical Resection (TAMIS/TEO) in Early Rectal Neoplasias

Endoscopic Submucosal Dissection Versus Local Laparoscopic Surgical Resection (Transanal Minimally Invasive Surgery [TAMIS] / Transanal Endoscopic Operation [TEO]) In Early Rectal Neoplasias. Multicentric and Randomized Clinical Trial

presence of remaining neoplastic tissue in resection site

Free margin of neoplastic tissue both laterally and deep

The length of the procedure expressed in minutes

Registration of any deviations on the normal postoperative period in the first 24 hours

Registration of any deviations on the normal postoperative period after the first 24 hours and up to 30 days after the procedure

Changes in patients' quality of life using validated scores (both, specific and non-specific)

Presence of remaining neoplastic tissue in resection site

Spanish Society of Digestive Endoscopy

Dr. Alberto Herreros de Tejada Echanojáuregui

Principal Investigator

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Adenocarcinoma, Clear Cell

Adenomyoepithelioma

Fallopian Tube Neoplasms

Adenocarcinoma

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

Fallopian Tube Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Epithelial-myoepithelial Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Niraparib

Tin Fluorides

3 cycles carboplatin + paclitaxel maintenance therapy with niraparib (starting dose 200 mg QD or 300 mg QD); maintenance continues until disease progression and/or death, unacceptable adverse event/s, patient and/or investigator decision, other protocol stopping criteria.

6 cycles carboplatin + paclitaxel and maintenance therapy with niraparib (starting dose 200 mg QD or 300 mg QD); maintenance continues until disease progression and/or death, unacceptable adverse event/s, patient and/or investigator decision, other protocol stopping criteria.

We hypothesise that recurrence free survival in patients receiving 3 cycles of chemotherapy followed by maintenance with niraparib is not inferior to 6 cycles of chemotherapy followed by niraparib in advanced HRDpositive high-grade ovarian cancer patients with no residual tumor mass following primary tumor debulking.

3 cycles chemotherapy instead of 6 cycles chemotherapy

6 cycles chemotherapy

Maren Keller, Dr.

Katja Gnausch

Jalid Sehouli, Prof. Dr. med.

Multicenter, randomized, open label study including patients with advanced HRDpositive high-grade ovarian cancer, fallopian tube cancer, primary peritoneal cancer and clear cell carcinoma of the ovary with no residual tumor mass following primary tumor debulking to determine recurrence free survival in patients treated with 3 cycles carboplatin + paclitaxel and maintenance therapy with niraparib vs. 6 cycles carboplatin + paclitaxel and maintenance therapy with niraparib.

This is a multicenter, randomized, open label study including patients with advanced (FIGO stage IIIA, IIIB, IIIC, or IV of the 2014 FIGO classification) HRDpositive high-grade ovarian cancer, fallopian tube cancer, primary peritoneal cancer and clear cell carcinoma of the ovary with no residual tumor mass following primary tumor debulking.

The main scope of the trial is to determine recurrence free survival in patients treated with 3 cycles carboplatin + paclitaxel and maintenance therapy with niraparib vs. 6 cycles carboplatin + paclitaxel and maintenance therapy with niraparib.

Patients will be randomized 1:1 to receive either 3 cycles carboplatin + paclitaxel maintenance therapy with niraparib (Arm A) or 6 cycles carboplatin + paclitaxel and maintenance therapy with niraparib (Arm B). Randomization will be performed according to the results of the NGS analysis and stratified either to BRCAm independent of LOH or LOHhigh/ BRCAwt, FIGO stage III vs. IV, and countries. In both of the arms, tumor assessments (CT or MRI) will be performed 9-12 weeks after the start of therapy (after 3rd cycle of chemotherapy), after another 9-12 weeks (during maintenance therapy in Arm A and after the 6th cycle of chemotherapy in Arm B) and every 6 months thereafter. The tumor marker CA-125 will be assessed every 12 weeks in both arms.

During chemotherapy treatment, clinical visits (blood cell counts, detection of toxicity) occur at least every 3 weeks (depending on the chemotherapy regimen). Serum pregnancy tests for WOCBP occur at least every 4 weeks. During maintenance therapy with niraparib, clinical visits (blood cell counts, detection of toxicity) occur every 4 weeks for the first 11 months and every 12 weeks thereafter. Serum pregnancy tests for WOCBP occur at least every 4 weeks. Complete physical examinations will take place every 12 weeks. Safety will be monitored continuously by careful monitoring of all adverse events (AEs) and serious adverse events (SAEs).

About 60 sites in 6 European countries will participate in this study to recruit 640 patients in 36 months.

A Phase II Randomized, Open Label Non-inferiority Study of NiraParib Maintenance After 3 vs. 6 Cycles of Platinum-based Chemotherapy in completeLy debUlked Advanced HRDpositive High-grade Ovarian Cancer patientS in First Line Therapy

A Phase II Randomized, Open Label Non-inferiority Study of NiraParib Maintenance After 3 vs. 6 Cycles of Platinum-based Chemotherapy in completeLy debUlked Advanced HRDpositive High-grade Ovarian Cancer patientS in First Line Therapy (N-Plus)

Scientists may submit a request for scientific use of the data after the first publication. This request shall be examined by the working group and the leading PI. After signing an agreement, the anonymous data can be made available to the scientist (password protected).

Recurrence free survival, defined as time from treatment randomization to the earliest date of assessment of first relapse or death by any cause

Time from randomization until the date of second objective disease progression or death by any cause

Patients are asked to answer the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30). Responses of questions 1-28 are based on a 4-point scale (1=not at all; 4=Very much), with a higher score indicating a high degree of symptomatology and must therefore be assessed negatively. Responses of questions 29 and 30 are based on a 7-point scale (1=Very poor; 7=Excellent), with a higher score indicating a better global health status.

Patients are asked to answer the EORTC QoL Questionnaire-Ovarian Cancer (QLQ-OV28). Responses are based on a 4-point scale (1=Not at all; 4=Very much), with a lower score indicating better symptoms.

Patients are asked to answer the short version of the SF-36 Health Survey (SF-12). The questionnaire contains a total of 12 questions with different response options. For questions 1, 8 and 12 there are 5 (1=excellent, 5=bad), for question 2-3 there are 3 (1=yes, very restricted, 3=no, not restricted at all) and for questions 9-11 there are 6 response options (1= always, 6 = never). Questions 4-7 can be answered with "Yes" or "No".

The safety objective is to characterize the safety and tolerability of 3 vs. 6 cycles of chemotherapy followed by maintenance therapy with niraparib in advanced HRDpositive high-grade ovarian cancer patients with no residual tumor mass following primary tumor debulking. The following safety parameters will be analyzed: adverse events and serious adverse events graded per NCI CTCAE, Version 5.0 criteria with time to onset/recovery, causality and outcome; changes in laboratory values, vital signs since baseline, treatment discontinuations and reason for discontinuation, death and cause of death etc. concomitant medications will be collected with time and reasons of use. These are routine safety parameters collected and analyzed in Phase II /III oncology trials.

The objective is to show that less cycles of chemotherapy are as efficient and at the same time less toxic. Additional cycles of chemotherapy significantly increase toxicity and therefore lead to an increase of costs regarding, e.g. in-patient treatment, concomitant medications to treat (S)AEs.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Endoscopic Submucosal Dissection vs Local Laparoscopic Surgical Resection (TAMIS/TEO) in Early Rectal Neoplasias	NCT03959839	Rectal Neoplasm...	ESD TAMIS TEO	18 Years -	Puerta de Hierro University Hospital
Endoscopic Submucosal Dissection vs Local Laparoscopic Surgical Resection (TAMIS/TEO) in Early Rectal Neoplasias	NCT03959839	Rectal Neoplasm...	ESD TAMIS TEO	18 Years -	Puerta de Hierro University Hospital
Endoscopic Submucosal Dissection vs Local Laparoscopic Surgical Resection (TAMIS/TEO) in Early Rectal Neoplasias	NCT03959839	Rectal Neoplasm...	ESD TAMIS TEO	18 Years -	Puerta de Hierro University Hospital
A Phase II Randomized, Open Label Non-inferiority Study of NiraParib Maintenance After 3 vs. 6 Cycles of Platinum-based Chemotherapy in completeLy debUlked Advanced HRDpositive High-grade Ovarian Cancer patientS in First Line Therapy	NCT05460000	Ovarian Cancer Fallopian Tube ... Primary Periton... Clear Cell Carc...	3 cycles chemot... 6 cycles chemot...	18 Years -	North Eastern German Society of Gynaecological Oncology

Spots Global Cancer Trial Database for r0

Every month we try and update this database with for r0 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for r0

Every month we try and update this database with for r0 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for r0 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.