Neoplasms

Digestive System Diseases

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Gastrointestinal Stromal Tumors

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

With institutional review board approval from Zagazig University Hospitals 338. A double-centre prospective study was conducted on prospectively collected data of all morbidly. 17 patients in Zagazig University Hospitals, Faculty of Medicine, Egypt and 321 patients done in bariatric surgery excellence unit in a tertiary hospital in Riyadh-KSA.

Excision of Gastric GIST along fundus or body of stomach in the same specimen of LSG with safety margin 1-2cm

Laparoscopic sleeve gastrectomy

Bassem M Sieda

LSG is thought to be the best choice for obese patients with conincidental GISTs, as a tumour can be resected along with resecting the stomach within the same procedure. The primary endpoint is that, how much does GIST suppose to be far from a staple line to do safe laparoscopic sleeve gastrectomy

The incidence of unsuspected GIST in LSG specimens in our series was high in comparison to cases reported in the literature.

GISTs could be safely removed laparoscopically during LSG surgery with negative microscopic resection margins, with 1-2cm safety margin. Margins less than 1cm, high mitotic rate are adverse prognostic factors.

Examining the whole stomach before resection is mandatory and can easily be done during LSG, GIST can be removed safely with LSG

Incidental Finding of Gastrointestinal Stromal Tumors (GISTs) During Laparoscopic Sleeve Gastrectomy, How to Deal? How Much Safety Margin

WHEN REGISTERED AND APPROVED FOR PUBLICATION, I WILL SHARE THROUGH ALL SCIENTIFIC SITES

we analyzed the incidence of GISTs in patients underwent LSG and investigated whether simultaneous resection can be oncologically adequate. as long as GIST is distal to staple line with a negative margin, laparoscopic sleeve gastrectomy can be done safely.

Bassem Mohamed Sieda

Assistant professor of general surgery, faculty of medicine

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Imatinib Mesylate

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

alternating 28-day periods of imatinib 400mg orally daily for 21 to 25 days followed by a washout (drug free) period of 3 to 7 days, then regorafenib 160mg orally daily for 3 weeks followed by a 7 day washout (drug free) period.

Regorafenib

imatinib

Heikki Joensuu, Professor

Desmond Yip, A/Professor

An open label randomised trial for adults with histologically confirmed measurable metastatic GIST who have received no other treatment for metastatic disease. The study aims to determine if an alternating regimen of imatinib and regorafenib has sufficient activity and safety in comparison to imatinib alone to warrant further evaluation as a first line treatment for metastatic GIST.

PROTOCOL SYNOPSIS Background Despite highly active current treatment for metastatic gastrointestinal stromal tumour (GIST) with the use of imatinib, most people will ultimately relapse and die of multifocal metastatic disease. Using an alternating regimen of imatinib and regorafenib with brief drug free intervals may allow tumour stem cells to re-enter the cell cycle and become susceptible once more to drug therapy. Regorafenib, a multi-targeted tyrosine kinase inhibitor (TKI) with activity against angiogenic, stromal and oncogenic receptor tyrosine kinases, has demonstrated activity in the treatment of GIST and is FDA approved for third line therapy of advanced GIST.

General aim To determine if an alternating regimen of imatinib and regorafenib has sufficient activity and safety to warrant further evaluation as a first line treatment for metastatic GIST.

Design Prospective, randomised, open label phase II trial, stratified by participating site, previous adjuvant therapy (prior vs none), and previous imatinib for metastatic disease for less than 21 days.

Population The target population is adults with histologically confirmed, measurable metastatic GIST, who have received no prior treatment for metastatic disease. Patients who are currently taking, and have had up to 21 days of uninterrupted treatment with 400mg daily of imatinib are eligible to participate in this study.

Study treatments

Patients will be randomised to receive either:

Arm A - imatinib 400mg orally daily continuously (control arm); or Arm B - alternating 28-day periods of imatinib 400mg orally daily for 21 to 25 days followed by a washout (drug free) period of 3 to 7 days, then regorafenib 160mg orally daily for 3 weeks followed by a 7 day washout (drug free) period.

Treatment will continue until disease progression or prohibitive adverse events as detailed in the protocol.

Statistical considerations In order to demonstrate a relative increase in progression free survival at 24 months from the date of randomisation from an expected 78% to 88%, with 80% power and 95% confidence based on A'Hern's adjustment to Fleming's design, approximately 110 evaluable participants will be required in each arm. Thus, it is proposed to enrol 240 participants into the trial, allowing for approximately a 10% drop-out rate. Currently 80% of participants are expected to achieve a clinical benefit at 24 months (CBR - rate of complete or partial response, or stable disease). A secondary outcome would be to determine whether a minimum 25% relative increase of the CBR (from 80% to 85%) in the experimental cohort can be attained. The study will be open to recruitment for 36 months while follow-up will continue until the last enrolled participant has been followed for a minimum of 24 months timed from the date of commencement of treatment.

A Randomised Trial of Imatinib Alternating With Regorafenib Compared to Imatinib Alone for the First Line Treatment of Advanced Gastrointestinal Stromal Tumour (GIST)

A Randomised Phase II Trial of Imatinib Alternating With Regorafenib Compared to Imatinib Alone for the First Line Treatment of Advanced Gastrointestinal Stromal Tumour (GIST)

This is defined as the rate of patients who proceed to surgery with the aim of resecting all remaining macroscopic disease.

to explore the relationship between change in PET imaging during washout period of regorafenib and imatinib (in subset of participants at selected centres)

To explore the relationship between study endpoints and Imatinib plasma levels at 4 and 12 weeks after commencement of treatment in both arms. Arm B: Imatinib plasma levels at 3 and 11 weeks after commencement of treatment and regorafenib plasma levels 7 and 15 weeks after commencement of treatment.

To explore the relationship between study endpoints and circulating other biomarkers as prognostic and/or predictive markers.

Rate of patients having macroscopically complete removal of all residual disease by surgery

The objective tumour response rate (OTRR) will be calculated by summing the number of participants assessed as having a complete or partial response within the first 9 months from the time from either (i) randomization (if patients have not yet commenced treatment) or (ii) commencement of therapy (if patients are randomized during the first cycle of imatinib), and dividing this by the total number of participants evaluable for response. For patients who undergo surgery, the best response is determined in the time period that precedes the date of surgery. The responses are confirmed at the time of the next scheduled imaging, usually done 8 weeks after the first detection of response, provided that imaging of the target lesions is not indicated sooner than this for other reasons. Both the numbers and the proportions of confirmed and unconfirmed responses will be reported. The minimum duration of SD is defined as 8 weeks.

PFS at 24 months as calculated from the time from either (i) randomization if patients have not yet commenced treatment) or (ii) commencement of therapy (if patients are randomized during the first cycle of imatinib) to the date of progression as determined by RECIST v1.1

Clinical benefit rate (SD + PR + CR) following 2 cycles of treatment

Time to treatment failure is defined as the time from either (i) randomization (if patients have not yet commenced treatment) or (ii) commencement of therapy (if patients are randomized during the first cycle of imatinib) to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, or death.

Overall survival is defined as the interval from either (i) randomization (if patients have not yet commenced treatment) or (ii) commencement of therapy (if patients are randomized during the first cycle of imatinib) to date of death from any cause, or the date of last known follow-up alive.

European Organisation for Research and Treatment of Cancer - EORTC

Scandinavian Sarcoma Group

Australasian Gastro-Intestinal Trials Group

Symptoms and General Pathology

Disease Progression

Sunitinib

Angiogenesis Inhibitors

Growth Inhibitors

Participants receive masitinib (12 mg/kg/day), given orally twice daily.

Participants receive sunitinib, given at 50 mg/day for 4 consecutive weeks out of 6 weeks, orally

Masitinib

Axel Le Cesne, M.D., Ph.D

The objective is to compare the efficacy and safety of masitinib at 12 mg/kg/day to sunitinib at 50 mg/day in the treatment of patients with gastro-intestinal stromal tumor (GIST) after progression with imatinib.

Masitinib is a selective tyrosine kinase inhibitor with potent activity against wild-type c-Kit, the juxta membrane domain of c-Kit, and PDGFR. Masitinib is also thought to promote survival via modulation of immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment. The objective is to compare the efficacy and safety of masitinib at 12 mg/kg/day with respect to sunitinib at 50 mg/day in the treatment of imatinib-resistant gastro-intestinal stromal tumor (GIST).

Masitinib in Patients With Gastrointestinal Stromal Tumour After Progression With Imatinib

A Prospective, Multicenter, Randomized, Open-label, Active-controlled, Two-parallel Groups, Phase 3 Study to Compare the Efficacy and Safety of Masitinib to Sunitinib in Patients With Gastrointestinal Stromal Tumor After Progression With Imatinib at 400mg as First Line Treatment

Overall survival is defined as time in months from the randomization date to the date of death due to any cause. If a patient is not known to have died, then OS will be censored at the date of last known date patient alive.

Survival rate is defined as the number of patients alive divided by the number of patients in the population of analysis. Assessed at week-8, -16, -24, and every 12 weeks thereafter.

Progression Free Survival is defined as the time from the randomization date until the date of earliest evidence of disease progression or death, for participants who progressed or died before subsequent cancer therapy. Disease progression will be assessed by the investigator on CT scan according to RECIST 1.1 criteria and/or CHOI criteria.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Incidental Finding of Gastrointestinal Stromal Tumors (GISTs) During Laparoscopic Sleeve Gastrectomy, How to Deal? How Much Safety Margin	NCT04344847	Excision Margin	Laparoscopic sl...	21 Years - 42 Years	Zagazig University
A Randomised Trial of Imatinib Alternating With Regorafenib Compared to Imatinib Alone for the First Line Treatment of Advanced Gastrointestinal Stromal Tumour (GIST)	NCT02365441	Gastrointestina...	Regorafenib imatinib	18 Years -	Australasian Gastro-Intestinal Trials Group
Masitinib in Patients With Gastrointestinal Stromal Tumour After Progression With Imatinib	NCT01694277	Gastrointestina...	Masitinib Sunitinib	18 Years -	AB Science

Spots Global Cancer Trial Database for gastrointestinal stromal tumour