Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasm Metastasis

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neoplastic Processes

Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

Evaluation of radiologic imaging and general condition by a multidisciplinary expert gremium to recommend either secondary intervention or resection of metastases or continuation of systemic treatment

Virtual centralized multidisciplinary tumour board

Arndt Stahler, MD

Matthias Wolff

Volker Heinemann, Prof.

This is a randomised, multicentre observational study in patients suffering from RAS mutant mCRC with primarily unresectable metastases, who are planned to be treated with FOLFOXIRI and bevacizumab or who have already received ≤ four cycles FOLFOXIRI and bevacizumab as first-line treatment of metastatic disease. The patients are randomised in a 1:1 ratio to compare the rate of patients in whom secondary interventions (e.g. resection, ablation) are performed in curative intent when secondary intervention options are assessed by a multidisciplinary centralized tumour board (Arm A) versus when secondary intervention options are not assessed by a multidisciplinary centralized tumour board (Arm B).

All patients evaluated in the study will receive chemotherapy with FOLFOXIRI plus bevacizumab. After this induction/conversion therapy, imaging (CT or MRI) will be performed to evaluate resectability. In Arm A, a multidisciplinary, centralized tumour board will assess options of secondary intervention to be performed in the context of a generally curative treatment approach.

If there are secondary intervention options according to the judgement of the centralized tumour board, they will be listed in their respective sequence and the assessment will be communicated to the participating physician or his/her deputy at the study center. The decision, whether or not any secondary intervention is performed as recommended by the centralized tumour board as well as the kind of interventional procedures is up to the discretion of the treating physicians and surgeons of each patient. Any secondary intervention is recorded.

Evaluating the primary endpoint, the first interventions performed in one organ (e.g. liver) are rated when performed in a generally curative context (e.g. even in the presence of lung metastases that need to be approached in a further intervention).

In Arm B, no centralized tumour board will be integrated in to clinical decision making and patients will be treated according to institutional guidelines.

The number of treatment cycles with FOLFOXIRI and bevacizumab will be according to local clinical routine and medical guidelines, recommended are 8 to 12 cycles FOLFOXIRI in combination with bevacizumab, followed by a maintenance therapy with fluoropyrimidine (FP) plus bevacizumab until progression.

Centralized Tumour Board and Secondary Intervention Rate in mCRC

Impact of a Centralized Tumour Board on Secondary Intervention Rate in Patients With RAS Mutant Metastatic Colorectal Cancer After First-line Treatment With FOLFOXIRI Plus Bevacizumab (FIRE-7)

Rate of patients in whom secondary interventions (e.g. resection, ablation treatment or combination of both) are performed in curative intent

Charité Universitätsmedizin, Department of Hematology, Oncology and Tumor Immunology

Ludwig-Maximilians - University of Munich

Principal Investigator

Healthcare workers/Physicians involved in cancer diagnosis \& management in the Arab countries should respond to a survey

Survey

Multidisciplinary clinics affect the quality of management of cancer patients. This Questionnaire is for research purposes aiming at exploring the application and implementation of multidisciplinary clinics in managing cancer patients in the Arab countries. The results of this survey will shed the light on the situation; the investigators aim at exploring the status of their implementation and who participates in them, in addition to exploring the challenges that face MDT clinics in Arab world.

Multidisciplinary teams (MDTs) are recommended as a corner stone of best cancer care nowadays. MDTs consist of many professionals such as medical, nursing, and allied professionals and diagnostic experts to determine the optimal treatment pathway for individual patients. They should be well organized and efficient. MDT clinics care is helpful in making clinical decision and improving the quality of patients' care. However, there are many challenges that face the actual implementation and application of MDT clinics in routine cancer patients' care in our Arab countries.

This study aims at describing the situation in our Arab countries and reflecting the pathway \& logistics of referring cancer patients to MDT \& the impact of that on the patients' management \& outcome, in addition to exploring the challenges that face effective implementation of MDT clinics, so that it can lead the improvement in oncology manangement

Application of MDT Clinics in Arab World

Assessment of Multidisciplinary Clinics Implementation in Cancer Patients' Management in Arab Countries

This Questionnaire is for research purposes aiming at exploring the application of multidisciplinary clinics in managing our cancer patients in the Arab countries and highlighting the challenges faced by oncologists trying to establish effective MDT clinics.The data will be published when completed.

We would like to know the rate of discussing suspected patients in MDT clinics. This will be done via a questionnaire.

We would like to know the main challenges to establish effective MDT clinics according to the physicians' point of view, who attend the MDT clinics . This will be done via a questionnaire.

We would like to know the rate of the well established MDT clinics and discussion during cancer patients' management. This will be done via a questionnaire.

We would like to know who usually participate and attend the MDT clinics during cancer patients' management. This will be done via a questionnaire.

Cairo University

Clinical Oncology Lecturer and consultant

Skin and Connective Tissue Diseases

Behaviors and Mental Disorders

Breast Neoplasms

Breast Diseases

Skin Diseases

Quality of Life

Patients receive standard of care breast surgery and subsequent whole breast irradiation

Breast conserving surgery

Niku KJ Oksala, Professor

The number of breast cancer survivors is constantly growing. Breast conserving surgery (BCS) is equal or superior to mastectomy both regarding survival and quality of life (QoL). Hence, as many patients as possible should be treated using BCS. The results indicate that the rate of mastectomies in Finland is higher than in Europe, while the rate of reoperations due to insufficient margins after BCS is lower in Finland than globally. With this study we aim to identify the optimal balance of radicality and tissue-conservation in BCS.

The aim of this study is to measure the volume of the resected breast tissue and the width of the healthy tissue margins and to compare these with the radiological and histological tumor size and with the size of the breast and their correlation with theoretically optimal and excised volumes.

This is a national prospective multicenter study conducted in five breast units. 250 women with primary, unilateral, cTis-T2 breast cancer eligible for BCS will be recruited. The diagnostics and treatment of the patients will be carried out following the Finnish national guideline. The size of the breast and the radiological size of the tumor will be measured preoperatively using mammograms and MRI. The histological tumor volume and the resection volume will be measured postoperatively. The optimal resection volume is calculated as the difference of the total resection volume and the volume of the tumor with an added 1 cm margin.

To map the impact of the treatment on QoL and body image, the patients are surveyed using EORTC-QLQ-C30 and BREAST-Q Breast Conserving Therapy Module QoL questionnaires preoperatively, 3-8 weeks postoperatively, and two years after the radiotherapy. Objective evaluation of the aesthetic outcome is assessed by the BCCT.core software that uses medical photographs taken at the same time points as the questionnaires are filled.

1. Background

   Breast cancer is the most common cancer worldwide. The prognosis of early-stage breast cancer is good - more than 90 % of the patients are alive five years after diagnosis. Since many patients live decades after the diagnosis, besides oncological outcome, aesthetic, and functional outcomes are important for patients as a factor of quality of life (QoL) and global health. Breast conserving surgery (BCS) is equal or superior to mastectomy (Mx) both regarding survival and quality of life (QoL). Even if a patient has had immediate breast reconstruction their body image is inferior after mastectomy compared to those undergoing BCS.

   The aim of BCS is to remove the tumor with histologically negative margins defined as no ink on tumor for invasive carcinoma and 2 mm histological margin for ductal carcinoma in situ (DCIS). Wider negative margins do not improve local control when BCS is combined with radiotherapy (RT) but predispose patients to larger excision volumes and inferior cosmetic outcomes. Contrastingly, more conservative resections are associated with positive histological margins, which double the risk of tumor recurrence. Therefore, re-operation is performed for positive histological margins. Rates of re-excision vary widely between surgeons and facilities and according to recent international studies are up to 30 %. Re-operation is associated with several adverse outcomes such as delayed adjuvant treatment and impaired cosmetic outcomes and QoL.

   Finding the right balance between BCS and mastectomies, and the optimization of resection volumes are important considerations for surgical care of breast cancer. BCS rate and reoperation rate are both quality indicators of the European Society of Breast Cancer Specialists. The rate of mastectomies for early breast cancer in certified European breast units is approximately 25 %. There is no exact data on the rate of Mxs according to progression for Finland, however, it appears to be higher than in European units. Contrastingly, 8-13 % of the patients having BCS require a reoperation due to positive histological margins in Finland. These findings raise the question whether more BCS could be performed and with smaller macroscopic margins.

   Since the variation in reoperation rates, rates of mastectomies and resection volumes is largely unexplained, more research is needed to identify the root causes to enable effective interventions and raise the standards of care. Tumors and their anatomical location in the breast, breasts of the patients and surgical techniques vary and therefore measuring the BCS is challenging. Additionally, long-term cosmetic and functional outcomes are confounded by the effect of radiotherapy, and final outcome can be observed no earlier than two years after operation. In practice, measuring the ratio of the tumor volume to resection volume could provide comparable data and could even be a quality indicator of BCS. Our team has previously studied the technological innovations for intraoperative margin assessment and conducted retrospective analysis on the breast cancer margins in Finland. To effectively assess the factors affecting the resection volumes and obtained margins, a prospective approach is needed. A multicenter approach gives a comprehensive look on variation between institutions and surgeons. A study of this nature has not been conducted before.
2. Aim of the study

   The aim of this study is to measure the volume of the resected breast tissue and the width of the healthy tissue margins and to compare these with the radiological and histological tumor size and with the size of the breast and their correlation with theoretically optimal and excised volumes. These results help breast surgeons to find optimal balance of radicality and tissue-conservation.

   Primary endpoints
   * What is the effect of breast-related QoL and objective aesthetic outcome, as measured with BCCT.core, of the treatment on patient's overall QoL?
   * Are there differences in resection volumes and patient-related outcomes between surgeons or breast centers?
   * The ratio of theoretically optimal and excised resection volume for the tumor

   Secondary endpoints
   * What is the effect of radiotherapy on breast volume and shape?
   * What is the effect of the preoperative multidisciplinary team (MDT) treatment plan on the results?
   * What is the reoperation rate due to positive histological margins?
   * What is the effect of the tumor subtype, tumor size, DCIS component, tumor palpability or preoperative MRI imaging on the resection margins?
3. Research methods and execution

   3.1 Trial design and participants

   This is a national prospective multicenter study with a sample of 250 patients. The inclusion criterion is primary, unilateral cTis-T2 breast cancer eligible for BCS. Both conventional and volume-displacement oncoplastic techniques can be applied as long as the procedure is unilateral. The patients will be recruited from five Finnish breast units. For one surgeon at least 20 procedures are required. The sample size is powered to detect differences between centres and individual surgeons (alfa=0.05, beta=0.2, effect size 0.3) with the presumed loss of a maximum of 20% of patients at 2-year follow-up in terms of primary endpoints.

   Exclusion criteria for the study are metastatic, bilateral, and hereditary breast cancers or earlier breast cancer of the same or contralateral breast. Also, a symmetrisation procedure of the healthy breast simultaneously with the cancer operation or earlier breast procedures (excluding bilateral reduction mammoplasty/mastopexy) are contraindications. If the patient is not eligible for radiotherapy, has received neoadjuvant treatment, is pregnant or breastfeeding or is unable to provide an informed consent, she is not included in the study.

   For all patients the following data will be collected: age, BMI, comorbidity, smoking status, hormonal status, radiological data of the patient's breasts and the tumor, preoperative MDT data, histopathological data on the tumor and the margins, details of the operative treatment, postoperative complications, and details of the oncologic treatments.

   For all breast units the following characteristics will be collected: annual number of new primary breast cancers and primary breast cancer operations, Mx-rate, number of immediate and delayed breast reconstructions, number of surgeons, information about MDT principles For all breast surgeons the following characteristics will be collected: age, gender, specialty, years of work experience and workplace The diagnostics and treatment of the patients will be carried out following the Finnish national guideline, which is in line with international guidelines. The patients will not undergo any additional laboratory tests or imaging. The data will be collected from examinations done routinely during the diagnostic phase and follow-up phase.

   3.2 Volumetric measurements and the resection ratio

   The breast volume is calculated preoperatively and after radiotherapy by using mammography measurements (breast height, breast width and compression thickness) and the preoperative tumor volume by mammography and/or by the MRI. The effect of radiotherapy on breast size is calculated by comparing the preoperative and postoperative volume of the breast while considering the resection volume.

   The fresh surgical specimen is submerged in saline and its volume is measured using calculations based on Archimedes principle and Newton's third law. The radiological and histological tumor volume is calculated assuming the tumor to resemble an obloid spheroid.

   Optimal resection volume (ORV) is defined as the spherical volume of the tumor with an added 1.0 cm margin of healthy breast tissue. Total resection volume (TRV) is the measured volume of the fresh surgical specimen. TRV is compared to ORV to determine the excess of breast tissue resection (TRV/ORV=CRR) defined as calculated resection rate (CRR). Optimal CCR is 1.0.

   3.3 Quality of life and aesthetic results

   To map the impact of the treatment on QoL and body image, the patients are photographed and surveyed using QoL questionnaires (EORTC-QLQ-C30 version 3.0 and BREAST-Q Version 2.0 Breast Conserving Therapy Module) preoperatively, 3-8 weeks postoperatively and two years after the radiotherapy. Objective evaluation of the aesthetic outcome is assessed by the 'BCCT.core software' - INESC Porto Breast Research group based on medical photographs. The photographs are taken at same time points as QoL questionnaires are filled.

   The tumor-to-TRV ratios are analyzed between surgeons and centers while controlling for potential confounders at 3-8 weeks after surgery. Additionally, the correlation of the factors with aesthetic and QoL measures is analyzed at 3-8 weeks after surgery and 2 years after RT when the effect of radiation and adjuvant therapies is also fully included.
4. Schedule

The trial inclusion will begin in the spring 2022. Before the inclusion we will do a pilot study of five patients to validate the measuring techniques, the QoL questionnaires and the BCCT.core program.

The results will be analyzed at two time points:

1. 3-8 weeks after the operation
2. two years after the radiotherapy

The final results of the study should be available during 2025. The results will be published in peer-reviewed journals of surgical oncology.

Factors Influencing Breast Cancer Resection Volumes And Their Impact on Treatment Outcome (FIBRATIO)

Factors Influencing Breast Cancer Resection Volumes And Their Impact on Treatment Outcome: a Prospective Multicenter Study (FIBRATIO)

What is the effect of breast-related QoL and objective aesthetic outcome, as measured by two QoL questionnires and with BCCT.core, of the treatment on patient's overall QoL?

Are there differences in resection volumes and patient-related outcomes between surgeons or breast centers?

The ratio of theoretically optimal and excised resection volume for the tumor

What is the effect of radiotherapy on breast volume and shape? Breast volume is measured preoperatively and two years after the radiotherapy. Breast volume based on mammogram data calculated using the formula proposed by Kalbhen et al, Am JRoentgenol. 1999: Volume = (π/4) × Breast height × Breast width × Compression thickness in cranio-caudal mammogram. Breast shape is assessed by BCCT.core.

What is the effect of the preoperative multidisciplinary team (MDT) treatment plan on the results? MDT planning will be assessed as YES or NO scale.

What is the reoperation rate due to positive histological margins?

What is the effect of the tumor subtype, tumor size, DCIS component, tumor palpability or preoperative MRI imaging on the resection margins?

Jyväskylä Central Hospital

Turku University Hospital

Kuopio University Hospital

Tampere University Hospital

Recurrence

Rectal Neoplasms

To assess the geographic variation that exists in the management of locally advanced and recurrent rectal cancers.

No specific intervention; cases are retrospective and patients have already been treated.

Matthew Fahy

The treatment of locally advanced and recurrent rectal cancers is highly individualized to each patient and their pattern of disease, and this decision is often made at the Multidisciplinary Team (MDT) meeting . The PelvEx collaborative was designed with the intent to provide greater international consensus on appropriate treatment decisions for this cohort. However, we propose that international variation exists in how certain patients will be evaluated, assessed and ultimately treated despite having the same disease. We plan to measure this variation in order to provide a greater understanding of the differences that exist.

The PelvEx collaborative is an international research collaborative that was designed with the aim of collating data on patients undergoing pelvic exenteration from all corners of the globe. These extensive procedures, despite their associated morbidity, have revolutionised the approach to advanced pelvic malignancy and provide hope to patients whose cancers would have once been deemed inoperable. Despite the increasing frequency with which surgeons are performing these more radical resections (1), relatively few of these procedures are carried out when compared with more traditional surgical operations. Furthermore, this cohort of patients and the wide-ranging procedures which they undergo represent a heterogenous group. These factors combine to make it more difficult for academic surgeons to draw meaningful conclusions from their study, and further illustrate the need for prospective international collaboration in order to inform appropriate treatment strategies.

However, despite the great demand for international collaboration, it is vital that there is an appreciation of the variation in the approach to managing these complex cases between hospitals, countries and continents. While surgeons would like to believe that in any case where their local multi-disciplinary team meeting has made an informed treatment decision that it is the single most appropriate option, geographic variation in beliefs, attitudes, terminology and patient preferences may influence those decisions at an individual level. Nowhere is this more relevant than in the approach to advanced pelvic malignancy. One study analysing regional variation in the management of locally advanced and recurrent rectal cancer noted a significantly lower rate of pelvic exenteration in France when compared with Australia, despite intercountry blinding of radiological findings (2). These differences are influenced by a host of psychosocial factors that are as yet to be fully elucidated.

The goal of the present analysis is to provide further insight in to the geographical variation that exists in the assessment of the patients who are potential candidates for a pelvic exenteration in the hope that it will improve our understanding of these differences and increase the validity of the conclusions that can be drawn from our research on a prospective collaborative basis.

This will be performed by having "real-world" cases selected by our participating centres, anonymising the case and radiological information necessary and by presenting these cases over a series of weeks at MDT meetings all over the world. The data will then be analysed to assess the differences in the ways that certain groups/countries approach the management of these complex and highly varied cases.

PelvEx 4: Advanced Pelvic Malignancy and the Role of the Multi-disciplinary Team Meeting

PelvEx 4: Advanced Pelvic Malignancy and the Role of the Multi-disciplinary Team Meeting - An International Assessment of MDT Decisions

Treatment consensus reached for each individual case

Was the malignancy felt to be resectable by MDT consensus at that institution

Concordance between centres on the TNM staging of disease

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Centralized Tumour Board and Secondary Intervention Rate in mCRC	NCT04852250	Metastatic Colo... RAS Mutation Multidisciplina... Secondary Inter...	Virtual central...	18 Years -	Ludwig-Maximilians - University of Munich
Application of MDT Clinics in Arab World	NCT05541770	Multidisciplina...	Survey	-	Cairo University
Factors Influencing Breast Cancer Resection Volumes And Their Impact on Treatment Outcome (FIBRATIO)	NCT05257577	Breast Cancer Quality of Life Patient Satisfa... Resection Margi... Surgical Margin Multidisciplina...	Breast conservi...	18 Years - 80 Years	Tampere University Hospital
Application of MDT Clinics in Arab World	NCT05541770	Multidisciplina...	Survey	-	Cairo University
PelvEx 4: Advanced Pelvic Malignancy and the Role of the Multi-disciplinary Team Meeting	NCT05076305	Multidisciplina... Locally Advance... Recurrent Recta... Multidisciplina... Treatment Decis...	No specific int...	18 Years - 80 Years	St Vincent's University Hospital, Ireland
Application of MDT Clinics in Arab World	NCT05541770	Multidisciplina...	Survey	-	Cairo University

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