Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasm Metastasis

Recurrence

Liver Neoplasms

Neoplasm Recurrence, Local

Disease Attributes

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Neoplastic Processes

Hematinics

All Drugs and Chemicals

Liver Extracts

Twenty patients with RFA/MWA for CRLM or RFA/MWA of recurrent liver lesions after prior local treatment of CRLM and are eligible to undergo MRI-scanning are included when they have adequate renal function. Patients that do not meet inclusion criteria for undergoing an MRI scan are excluded.

All patients will undergo PET-MRI additional to the PET-CT they routinely undergo. All patients will be administered Gadolinium for the PET-MRI scan. This is an extra intervention than they would normally undergo.

Gadolinium

Petrousja van den Tol, MD PhD

Indra C Pieters, MD PhD

Emile FI Comans, MD PhD

The primary objective of this study is to evaluate the ability of PET-MRI and to detect a local site recurrence during the first year of follow-up after RFA or MWA of colorectal liver metastases (CRLM) as compared with contrast enhanced (ce) CT and PET-CT. Standard reference will be clear focal uptake in the rim of the lesion on PET-CT, possibly in combination with histology (when available) or clinical follow-up.

Secondary outcomes are the inter-observer variability, the ability to diagnose new intrahepatic lesions and in what way PET-MRI is able to influence future treatment compared to PET-CT and ceCT. The patients satisfaction concerning the PET-MRI will be examined with a questionnaire.

All included patients will routinely undergo follow-up with 3 monthly ceCT of the liver and PET-CT in the first year after RFA/MWA of CRLM according to standard of care in our hospital. Patients are asked to undergo an additional PET-MRI of the liver on the same day in the first year (in total 4 scans). The PET-MRI is obtained before the PET-CT. The 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) used for PET-CT and PET-MRI are alike and one injection is sufficient. The PET-CT has to be made within 150 minutes after FDG injection. Anonymous PET-MRI results are independently reviewed by 2 experienced radiologists and 2 nuclear medicine physicians twice, with a time-interval of at least two weeks between the first and second review. Based on these results, treatment decisions will be compared for any change in decision making.

The evaluate inter-observer variability we will ask the two nuclear medicine physicians and two radiologist to assess all results and score local and intrahepatic tumor progression. Results of the first and second evaluation will be compared to determine inter observer agreement using Cohen's Kappa. Local recurrence and new lesions will be scored on a separate form with standard criteria.

The reports on LSR will be scored as follows:

* Normal: when the reviewer is sure that no tumor recurrence is present in the ablation zone.
* Probably benign: FDG is enhanced, but compatible with post-ablation inflammation or rim-like characteristics on MRI images (not focal!)
* Equivocal: there is doubt whether the enhanced FDG, CT- or MRI features are due to tumor recurrence or inflammation
* Probably malign: when the reviewer is sure about local recurrence in the ablation zone. Size and location will also be reported.

The reports on new intrahepatic lesions will be scored as follows:

* Normal: no new intrahepatic disease outside 1cm of the ablation zone
* Equivocal: doubt about the malignant origin of a lesion
* Probably malign: new intrahepatic tumor not within 1cm of the ablation zone, including size and location.

The results of all scans by the reviewers, in the way as described above, will be compared to each other to determine the inter-observer variability using Cohen's Kappa.

A questionnaire with 7 questions is completed at the end of one year follow-up to determine patients experience with PET-MRI and PET-CT.

The questions will be in Dutch, but are translated below for this purpose. Patients can answer on a scale 1-5 and n/a.

* The PET-MRI was less burdensome than PET-CT
* The PET-MRI was more bothersome than I expected
* PET-MRI is more comfortable than PET-CT
* If I could choose, I would rather undergo PET-MRI than PET-CT
* The noise of the PET-MRI was annoying
* The fact that PET-MRI takes longer than PET-CT isn't an issue for me
* I would rather undergo a PET-MRI than a PET-CT if results are proven to be equal

PET-MRI After Radiofrequency Ablation (RFA) or Microwave Ablation (MWA)

The Use of PET-MRI in the Follow-up of RFA and MWA Treated Colorectal Liver Metastases

The primary objective of this study is to evaluate the ability of PET-MRI and diffusion and contrast enhanced MRI to detect LSR during the first year of follow-up after RFA treatment of CRLM as compared with ceCT and PET-CT. Standard reference will be clear focal uptake in the rim of the lesion on PET-CT, possibly in combination with histology (when available) or clinical follow-up.

the ability of PET-MRI to diagnose smaller new intrahepatic lesions than PET-CT and ceCT

Hard copy data sets of all PET-MRI and PET-CT scans, with no patient information, random order, independently reviewed by 2 experienced radiologists and 2 nuclear medicine physicians twice (reviewers blinded to the images and results of the other imaging modalities and blinded to the final outcome of patients), with a time-interval of at least two weeks between the first and second review. These scans are scored on a standardized form (explained in the section 'detailed description'). The outcomes between the different reviewers of the same scan are noted and compared to each other. Inter observer variability is determined using Cohen's Kappa.

in what way PET-MRI is able to change future treatment compared to PET-CT and ceCT

A questionnaire with 7 questions is completed at the end of one year follow-up to determine patients experience with PET-MRI and PET-CT. This is done to get an idea of the possible objections and wishes of all patients. Results will be described.

The questions will be in Dutch, but are translated below for this purpose. Patients can answer on a scale 1-5 and n/a.

* The PET-MRI was less burdensome than PET-CT
* The PET-MRI was more bothersome than I expected
* PET-MRI is more comfortable than PET-CT
* If I could choose, I would rather undergo PET-MRI than PET-CT
* The noise of the PET-MRI was annoying
* The fact that PET-MRI takes longer than PET-CT isn't an issue for me
* I would rather undergo a PET-MRI than a PET-CT if results are proven to be equal

dr. M.P. van den Tol MD PhD

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

Oxaliplatin

Fluorouracil

Irinotecan

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Topoisomerase I Inhibitors

Enzyme Inhibitors

FOLFIRI \* 6 cycles +/- radiotherapy -\> surgery -\> FOLFIRI \* 6 cycles

Surgery -\> FOLFIRI \* 12 cycles +/- radiotherapy

5-fluorouracil

Local radiotherapy

R0 resection

Jian Xiao, MD

Ping Lan, MD

Colorectal cancer (CRC) is one of the most leading causes of cancer death in China. Although multiple treatment modalities including surgery, radiotherapy and chemotherapy have been developed, the prognosis of advanced CRC still remains poor. While around 30% of resectable advanced CRC could be cured. This study is designed to compare perioperative FOLFIRI versus adjuvant FOLFIRI in resectable advanced CRC who exposed to oxaliplatin in open-label, phase III mode.

Perioperative FOLFIRI VS Adjuvant FOLFIRI in Resectable Advanced CRC Failed to Oxaliplatin

Randomized Open-label Phase III Study Comparing Perioperative FOLFIRI Versus Adjuvant FOLFIRI in Resectable Advanced Colorectal Cancer Failed to Oxaliplatin-containing Treatment

Adverse events grade that greater than 3 is considered secondary endpoint, according to the Common Terminology Criteria for Adverse Events Version 3.0.

Sixth Affiliated Hospital, Sun Yat-sen University

Professor

Rectal Neoplasms

patients operated before summer 1995, that is before the introduction of TME

patients operated after summer 1995, that is after the introduction of TME.

type of rectal surgery before the introduction of TME

conventional rectal surgery

total mesorectal excision

Pietro Renzulli, MD

Total mesorectal excision (TME) is a rather new operation technique in the treatment of rectal cancer. It is known to reduce the rate of local recurrences. However, the influence on long-term survival is unclear.

Background

The TME technique for rectal cancer surgery was introduced in our department in summer 1995. TME is known to reduce the rate of local recurrences. However, its influence on long-term survival in unclear.

All patients with rectal cancer from 1993 to 2001 are reviewed. The patients charts are reviewed and the following main characteristics are retrieved: age, gender, time of operation, operation technique, tumor stage, tumor localisation, tumor size, neoadjuvant or adjuvant treatment, complications, follow-up with respect to the appearance of local recurrences and distant metastases.

Comparison of two groups of patients. Group 1: patients operated before summer 1995, that is before the introduction of TME. Group 2: patients operated after summer 1995, that is after the introduction of TME.

Objective

Study the influence of a new operation method (TME) on outcome (local recurrence, survival).

Methods

All patients with rectal cancer from 1993 to 2001 are reviewed. The patients charts are reviewed and the following main characteristics are retrieved: age, gender, time of operation, operation technique, tumor stage, tumor localisation, tumor size, neoadjuvant or adjuvant treatment, complications, follow-up with respect to the appearance of local recurrences and distant metastases.

Comparison of two groups of patients. Group 1: patients operated before summer 1995, that is before the introduction of TME. Group 2: patients operated after summer 1995, that is after the introduction of TME.

Introduction and Influence of Total Mesorectal Excision (TME) in the Treatment of Rectal Cancer

Introduction of Total Mesorectal Excision (TME) in the Treatment of Rectal Cancer. Influence of This New Operation Technique on Local Recurrence and Long-Time Survival. Retrospective Study: 1993-2001

Insel Gruppe AG, University Hospital Bern

Pietro Renzulli MD

Skin and Connective Tissue Diseases

Breast Neoplasms

HIOB: IOERT of 11.1 Gy followed by WBRT with 15 times 2.7 Gy per fraction.

IOERT single shot as a boost followed by hypofractionated WBRT (HIOB)

* IOERT is performed on mobile or fixed linacs
* Reference dose: 11 Gy specified as maximum dose, with a minimum target volume dose of 90% encompassing the PTV (i.e. 10 Gy).

WBRT

* must start within day 36- 56 postoperatively (week 6 - 8 p.o.) in case of adjuvant hormonal treatment (or no further tumor specific medication)
* In case of adjuvant chemotherapy, a time - gap between IOERT and WBRT up to 9 months is allowed.
* Single reference dose per fraction: 2,7 Gy (ICRU)
* Number of fractions: 15, Number of fractions per week: 5
* Total WBRT dose: 40,5 Gy

HIOB

Gerd Fastner, Assoc.Prof.

Title:

HIOB - Hypofractionated Whole-Breast Irradiation preceded by Intraoperative Radiotherapy with Electrons as anticipated Boost ISIORT- 01

HIOB is defined as hypofractionated WBRT (40,5 Gy in 2,7 Gy per fraction) preceded by an Intraoperative Boost to the tumor bed ( 90 % reference dose of 10 Gy, 11,1 Gy Dmax IOERT).

Primary endpoint is the proof of superiority of a new treatment regimen.

The HIOB study concept is supposed to test the hypothesis whether such a combined schedule is superior (or iso-effective) towards "standard" RT in terms of local control and cosmetic outcome.

In the vast majority of all publications, annual and 5 year in-breast recurrence rates following BCT showed a clear dependency on patient age within the following boundaries (primary references):

Age \> 50: Bartelink (standard): 0,7% (annual) 3,5% (5y) START B (best): 0,4 %(annual) 2,0% (5y)

Age 41-50: Bartelink (standard) 1,2% (annual) 6,0% (5y) Whelan (best) 0,72%(annual) 3,6% (5y)

Age ≥ 35-40 Bartelink (standard) 2% (annual) 10% (5y) Whelan (best) 0,72% (annual) 3,6% (5y)

long these three different age groups, benchmarking will be performed against the best published results following 'Golden Standard'RT, usually defined as conventionally fractionated WBRT with 50 Gy (25 x2) plus external tumor bed boost with 10-16 Gy electrons (5-8x2Gy).

Superiority is defined as going below the lower limit of the estimated 5 year local recurrence rate within the respective age group Inferiority is defined as crossing the respective upper limit .

Secondary endpoint:

Disease free survival

Tertiary endpoint: toxicity assessment (acute and late) including long term cosmetic evaluation

Study design and statistics:

* Prospective multicenter single-armed
* Sequential probability ratio test (SPRT)
* Separate analysis within three different age groups

Estimated Accrual time: strongly dependent on recruitment per year within the respective age group . Due to the statistical estimation of Szenario A and B the study will close after max. Time-period of 10 years in case of A or 6,4 years in case of B..

Principal investigators and study coordinators:

UC of Radiotherapy and Radio-Oncology UC of Special Gynecology and Breast Cancer Center Landeskrankenhaus Salzburg, Paracelsus University Clinics

Study population:

See Points 4.1 und 4.2 Inclusion/Exclusion criteria of the entire protocol

Operation:

* Lumpectomy / segmentectomy / tumorectomy with sufficient safety margins (see above). Lymph node assessment must follow a sentinel node concept.
* Perioperative antibiotic prophylaxis is mandatory
* After IORT, radio-opaque clips have to be fixed at the tumor bed.

Histology: R0-Resection is mandatory

Chemotherapy:

neoadjuvant:allowed adjuvant: allowed.

There are no limitations towards special chemotherapeutic schemes and schedules.

Radiotherapy:

IOERT

* IOERT is performed on mobile or fixed linacs
* Reference dose: 11 Gy specified as maximum dose, with a minimum target volume dose of 90% encompassing the PTV (i.e. 10 Gy).

WBRT

* must start within day 36- 56 postoperatively (week 6 - 8 p.o.) in case of adjuvant hormonal treatment (or no further tumor specific medication)
* In case of adjuvant chemotherapy, a time - gap between IOERT and WBRT up to 9 months is allowed.
* Single reference dose per fraction: 2,7 Gy (ICRU)
* Number of fractions: 15, Number of fractions per week: 5
* Total WBRT dose: 40,5 Gy

RT of regional lymphatics: exclusion criterion

Diagnostics of Local recurrence:

* yearly mammographies,
* optional breast sonography, MRI
* LR has to be histologically confirmed

Follow-up screening for detection of metastases (minimum requirements):

* Chest X-Ray, optional
* abdominal sonography, optional
* lab tests incl. tumor markers, optional

Assessment of acute toxicity of WBRT according to CTC-toxicity Scoring-systems:

Assessment of late toxicity according to LENT-SOMA scoring-systems

Assessment of cosmetic outcome according to 5-point- Scoring System (vanLimbergen) starting before WBRT, including photo documentation in standardized positions

Intra-Operative Electron Boost and Hypofractionated Whole-Breast Irradiation During Breast-conserving Treatment (BCT)

Hypofractionated Whole-Breast Irradiation Preceded by Intra-Operative Radiotherapy With Electrons as Anticipated Boost HIOB A New Option in Breast-Conserving Treatment for Operated Breast Cancer Stages I and II

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PET-MRI After Radiofrequency Ablation (RFA) or Microwave Ablation (MWA)	NCT01895673	Liver Neoplasms Local Neoplasm ...	Gadolinium	18 Years -	Amsterdam UMC, location VUmc
Perioperative FOLFIRI VS Adjuvant FOLFIRI in Resectable Advanced CRC Failed to Oxaliplatin	NCT02087475	Colorectal Neop... Effects of Chem... Surgery Metastasis Local Neoplasm ...	Irinotecan 5-fluorouracil Local radiother... R0 resection	18 Years - 80 Years	Sixth Affiliated Hospital, Sun Yat-sen University
Introduction and Influence of Total Mesorectal Excision (TME) in the Treatment of Rectal Cancer	NCT00910143	Rectal Cancer	conventional re... total mesorecta...	16 Years -	Insel Gruppe AG, University Hospital Bern
Intra-Operative Electron Boost and Hypofractionated Whole-Breast Irradiation During Breast-conserving Treatment (BCT)	NCT01343459	Local Neoplasm ... Toxicity	HIOB	35 Years -	Paracelsus Medical University
Introduction and Influence of Total Mesorectal Excision (TME) in the Treatment of Rectal Cancer	NCT00910143	Rectal Cancer	conventional re... total mesorecta...	16 Years -	Insel Gruppe AG, University Hospital Bern

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