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

All the patients in the cohort will receive surgery o local (endoscopic) treatment, in some cases additional surgical treatment will be performed after an endoscopic primary treatment. This decision will have been taken based on daily clinical practice and does not represent a study intervention.

Surgery or Endoscopic treatment

The implementation of population screening programs for colorectal cancer (CRC) has led to a considerable increase in the prevalence T1 CRC originating on polyps amenable by endoscopy. The benefits of secondary oncological surgery in terms of disease free survival are not well established.

Hypothesis: The characteristics of the individuals and the polyp (endoscopic, histological) should allow us to discriminate T1 CRCs that may benefit from secondary surgery from those that only require local treatment. With the current criteria, the management of patients with T1 CRC is suboptimal since a high proportion of patients are refered for unnecessary surgeries without a clear benefit in terms of survival. Molecular signatures can help to discriminate those patients with good prognosis that do not require secondary surgery nor cancer related follow up.

The primary objective of the study is to compare the effect of oncological surgery versus local treatment for the management of polyps with T1 CRC in relation to disease-free survival and morbi-mortality of the therapeutic procedure. We will also validate molecular signatures in endoscopic samples for the prediction of lymph node metastasis and survival. Methodology: Clinical Study: Retrospective population-based cohort study that will include baseline clinical and follow up data of more than 1400 T1 CRCs in at least 10 Spanish autonomous communities from 2007 to 2017. A centralized pathological review will be carried out by a group of expert pathologists. Inter and intraobserver variability for histological staging will be assessed. A predictive model will be created to discriminate individuals with high probability of receiving surgical and local treatment. For those patients who have a similar probability range, the results in progression-free survival and adverse events will be compared. Translational phase: A 5miRNAs and 8mRNA signature predictive of lymph node metastasis will be assessed in 200 endoscopic samples and related with prognosis.

Tissue samples. A 10μm slice of the FFPE block will be obtained after manual microdissection of the area with cancer. The molecular study will be carried out in patients who have signed a biobank informed consent prior to the start of this study.

Endoscopic Versus Surgical Treatment for T1 Colorectal Cancer

Endoscopic Versus Surgical Treatment for T1 Colorectal Cancer: a Population-based Cohort Study

Evaluate the effect of surgery and local (endoscopic) treatment on overall survival (expressed in months)

Evaluate the effect of surgery and local (endoscopic) treatment on disease free survival (expressed in months)

Determine factors associated with the choice of primary treatment and final treatment (endoscopic, primary surgery or secondary surgery) and to develop a predictive model that allow discriminate individuals with high probability of receiving surgical treatment

Evaluate the validity of molecular signatures based on mRNA and miRNA (determined in endoscopic samples) for prediction lymph node metastasis

Determine the prognosis of patients with pT1CRC in relation to the treatment received (local, primary surgery or secondary surgery)

Evaluate the factors of the individual and the polyp that are associated with lymph node metastasis

Evaluate the inter-intraexplorer concordance of the pathologists for the histological staging criteria.

Compare the characteristics of the T1 CRCs diagnosed within a population screening program and outside it.

Evaluate the proportion of adverse effects after endoscopic or surgical treatment

To evaluate the performances of the different tests (CT, US, blood markers, colonoscopy) during follow up for detecting recurrence

Fundacion Clinic per a la Recerca Biomédica

Hospital Clinic of Barcelona

Principal Investigator. Attending physician Gastroenterology department.

Recurrence

Rectal Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Oxaliplatin

Leucovorin

Fluorouracil

Irinotecan

Capecitabine

Levoleucovorin

Folic Acid

Folfirinox

Folinic Acid

Folate

Vitamin B9

Protocol of chemotherapy FOLFIRINOX\*, 6 cycles :

* oxaliplatin: 85 mg/m2
* irinotecan: 180 mg/m²
* folinic acid: 400 mg/m2
* 5FU : 400 mg/m2 (bolus)
* 5FU : 2400 mg/m2 (continuous infusion)

Protocol of reirradiation consists in conformational intensity modulated external irradiation, delivering a 30.6 Gy dose (1.8 Gy/day), with concomitant chemotherapy including Capecitabine 1600 mg/m²/day, five days a week.

Protocol of chemotherapy FOLFIRINOX\*, 6 cycles :

* oxaliplatin: 85 mg/m2
* irinotecan: 180 mg/m²
* folinic acid: 400 mg/m2
* 5FU : 400 mg/m2 (bolus)
* 5FU : 2400 mg/m2 (continuous infusion)

* oxaliplatin: 85 mg/m2
* irinotecan: 180 mg/m²
* folinic acid: 400 mg/m2
* 5FU : 400 mg/m2 (bolus)
* 5FU : 2400 mg/m2 (continuous infusion)

Chemotherapy FOLFIRINOX, 6 cycles

Reirradiation consists in conformational intensity modulated external irradiation (Intensity-modulated radiotherapy Volumetric Modulated Arc Therapy or tomotherapy) delivering a 30.6 Gy dose with high-energy photons in fractions of 1.8 Gy per day (17 fractions) 5 days a week With Concomitant chemotherapy including Capecitabine 1600 mg/m²/day, five days a week.

Radiochemotherapy

Surgery will be performed at:

* Arm A: 8 weeks (±1) after the end of treatment
* Arm B: 6 weeks (±1) after the end of treatment

Surgical procedures are defined into three categories:

* Total mesorectal excision (TME)
* Extended-TEM (e-TME)
* Pelvic exenteration (PE)

Surgery

Christophe LAURENT

GRECCAR 15 is focused on Locally Recurrent Rectal Cancer (LRRC) for patients with previous pelvic radiotherapy for the primary rectal cancer. This situation leads to a 20% higher risk of non-curative resection for the LRRC management (R1 status) impacting significantly the overall survival. The widespread use of neoadjuvant radiotherapy for primary rectal cancer introduces this new problem: the treatment of LRRC in previously irradiated area.

The objective of GRECCAR 15 is to assess the efficacy of neoadjuvant chemotherapy followed by pelvic reirradiation versus neoadjuvant chemotherapy alone on the rate of curative surgery (R0) in previously irradiated patients with LRRC.

The incidence of rectal cancer in the European Union is 15-25/100 000 per year. There is a 5-10% rate of locally recurrent rectal cancer (LRRC), with an overall survival rate of 40% at 5 years after complete resection. Curative surgery of LRRC requires multi-visceral resections which are associated with significant post-operative morbidity of 60%. Despite the combination of a potential curability and the high post-operative morbidity, there are currently neither good data from prospective randomized studies regarding optimum preoperative treatments for LRRC nor is there data assessing the efﬁcacy of response to any such treatments. Moreover, the widespread use of neoadjuvant radiotherapy for primary cancer introduced a new problem: the treatment of LRRC in previously irradiated area. Some studies investigated various modalities of reirradiation and showed acceptable late toxicity and encouraging outcome. GRECCAR 15 would be the first prospective randomized trial so far to evaluate the interest of pelvic reirradiation for LRRC, in previously irradiated patients.

The objective is to assess the efficacy of neoadjuvant chemotherapy followed by pelvic reirradiation versus neoadjuvant chemotherapy alone on the rate of curative surgery (R0) in previously irradiated patients with LRRC.

Patients will be followed every 4 months during 2 years, and every 6 months the last year with chest, abdominal and pelvic scan and tumour markers.

Chemotherapy Followed by Pelvic Reirradiation Versus Chemotherapy Alone as Pre-operative Treatment for Locally Recurrent Rectal Cancer

A Phase III Randomized Trial Evaluating Chemotherapy Followed by Pelvic Reirradiation Versus Chemotherapy Alone as Pre-operative Treatment for Locally Recurrent Rectal Cancer (GRECCAR - PRODIGE - FRENCH)

To analyse surgical morbidity (Dindo classification) during first 30 days after the surgery

To analyse surgical mortality (Dindo classification) during first 30 days after the surgery

Proportion of patients receiving full allocated neoadjuvant treatment

Rate of tumor with a decreasing size of 50% at least after preoperative treatment at MRI

The scores of questionnaire QLQ C-30 will be examined The EORTC QLQ-C30 is a patients self-rating questionnaire that measures physical, role, social, emotional, and cognitive functions as well as overall QoL. Scores can be linearly transformed to provide a score from 0 to 100. Higher scores represent better functioning on the functional scales and a higher level of symptoms of the symptom scales.

The scores of questionnaire QLQ CR-29 will be examined. The EORTC QLQ-CR29 has five functional and 18 symptom scales. Scores can be linearly transformed to provide a score from 0 to 100. Higher scores represent better functioning on the functional scales and a higher level of symptoms of the symptom scales.

University Hospital, Bordeaux

Behaviors and Mental Disorders

Quality of Life

Intervention group: would receive EN reaching up to 20 % of daily nutritional requirements and early (on first day of stay in ICU) provision (of up to 80%) of protein (2 g/kg/ day or in case of continuous renal replacement therapy (CRRT) 2,5 g/kg/ day) and caloric (15-20 kcal/kg/day) needs in SPN that would be continued until 7th day of stay in ICU for the purpose of the study.

Control group: would receive EN reaching up to 20 % of daily nutritional requirements and late (of up to 80%) of protein (2 g/kg/ day or in case of CRRT 2,5 g/kg/ day) and caloric (15-20 kcal/kg/day ) in SPN on 7th day of stay in ICU if it is not already met via enteral route.

Intervention group: would receive EN reaching up to 20 % of daily nutritional requirements and early (on first day of stay in ICU) provision (of up to 80%) of protein (2 g/kg/ day or in case of CRRT 2,5 g/kg/ day) and caloric (15-20 kcal/kg/day) needs in SPN that would be continued until 7th day of stay in ICU. Central venous catheter placement would not be assessed as a part of intervention due to the fact that it is a part of routine medical activities performed during admission to ICU.

Early Supplemental Parenteral Nutrition

Paweł Piwowarczyk, MD PhD

Mirosław Czuczwar, MD PhD

Michał Borys, MD PhD

BACKGROUND: Nutrition plays a significant role in ICU treatment, and may influence mortality and length of stay in ICU. Enteral route (EN) is preferential to parenteral route (PN) in provision of daily nutritional requirements. When enteral route is insufficient, supplemental parenteral nutrition (SPN) is recommended. Optimal timing of SPN in acute phase of illness remains elusive. ICU patients suffer significant lean body mass loss, in majority, in the first 7-10 days of stay. Optimal provision of protein may prevent muscle wasting. Lean body mass is essential for optimal physical functioning after treatment. Although ICU mortality has been reduced lately, the number of patients going to rehabilitation after ICU stay has tripled. Patients after oncological surgery of the gastrointestinal tract may be threatened with impairment of physical functioning after ICU treatment.

AIM: To compare the influence of early and late supplemental parenteral nutrition on long-term physical functioning in ICU patients after oncological surgery of the gastrointestinal tract.

STUDY DESIGN: Prospective, randomised, multi-centre assessor-blinded study. METHODS \& ANALYSIS: Patients will be randomised into intervention group that would receive SPN on first day, and would be continued until 7th day of stay in ICU. Control group would receive SPN on 7th day of stay in ICU, when it is not then already met via enteral route. Physical Component of SF-36 Scale at 6 month after ICU admission will be assessed.

prospective, randomised, multi-centre assessor-blinded study

Influence of Early vs Late SPN on Long-term Quality of Life in ICU Patients After Gastrointestinal Oncological Surgery

Influence of Early vs Late Supplemental ParenteraL Nutrition on Long-term Quality of Life in ICU Patients After Gastrointestinal Oncological Surgery. A Prospective, Randomised, Multi-centre Assessor-blinded Study. hELPLiNe Trial

Long-term quality of life measured in physical component of 36 -SF questionnaire

Inability to administer up to 60% of protein needs on 3rd day via enteral route

Change from baseline in ultrasound measured thickness of diaphragm

Protein delivery defined as daily input of proteins via SPN

Energy delivery defined as daily input of calories via SPN

Insulin dose defined as summary daily input of insulin

Blood glucose profile defined as mean daily glucose level

Organic phosphorus level defined as result in blood test performed daily

We will collect data regarding changes from baseline SOFA score - to determine the extent of a person's organ function failure. SOFA scoring system is useful in predicting the clinical outcomes of critically ill patients. Patient can be scored from 0 to 24. If the patient is scored 0 than the patient is in a good state and predicted mortality is low, while 24 is the worst result with expected very high mortality rate.

Numbers of days of mechanical ventilation

Numbers of days of patient stay in hospital

New onset of health-care associated infection

Number of days patient was not given the antibiotics

Uniwersytecki Szpital Kliniczny w Opolu

Medical University of Lublin

Principal Investigator

Nutritional and Metabolic Diseases

Obesity

Obesity, Morbid

Overweight

Overnutrition

Nutrition Disorders

Body Weight

Patients candidates for resective surgery for rectal cancer and also elegible for bariatric surgery

BIB positioning in obese patients with rectal cancer elegible for neoadjuvant therapy

BIB positioning

Mario Musella, MD

Nunzio Velotti

Obesity worsens treatment outcomes in rectal cancer patients: the local resective approach could in fact be more difficult in obese patients due to limited surgical visibility and it has also been reported that high visceral adiposity determines an increased risk of recurrence after chemoradiotherapy neoadjuvant. Bariatric surgery has proved to be the best choice for the treatment of morbid obesity and related comorbidities and in this context, the intragastric balloon (IGB) represents a strategy characterized by a low rate of complications and good results in terms of weight loss.

Therefore, the need to be able to offer obese patients suffering from rectal cancer the possibility of a better recovery perspective, alongside radical oncological surgery and neoadjuvant treatments, also a bariatric surgery such as the positioning of an intragastric balloon.

Epidemiological data show that obesity is associated with a 30-70% increase in the risk of developing rectal cancer; Obesity could also be associated with a worsening of the tumor prognosis, with an increased risk of recurrence and increased mortality. From this point of view, recent studies have shown that a BMI ≥ 30 kg/m2 is associated with higher oncological and functional risks in patients with locally advanced rectal cancer, with lower response rates to neoadjuvant treatment and a less frequent preservation of the anal sphincter.

Obesity also worsens treatment outcomes: the local resective approach could in fact be more difficult in obese patients due to limited surgical visibility and it has also been reported that high visceral adiposity determines an increased risk of recurrence after chemoradiotherapy neoadjuvant. Bariatric surgery has proved to be the best choice for the treatment of morbid obesity and related comorbidities and in this context, the intragastric balloon (IGB) represents a strategy characterized by a low rate of complications and good results in terms of weight loss.

The most recent studies on the subject have shown that IGBs are effective in producing weight loss ranging from 6% to 15% compared to 1% -5% produced by lifestyle interventions alone Therefore, the need to be able to offer obese patients suffering from rectal cancer the possibility of a better recovery perspective (reduction of intra- and peri-operative complications, increased disease-free survival and lower risk of long-term recurrence) is underlined. ), alongside radical oncological surgery and neoadjuvant treatments, also a bariatric surgery such as the positioning of an intragastric balloon.

Evaluation of Surgical Complications and DFS in Obese Rectal Cancer Patients

Evaluation of Intra- and Peri-operative Complications and Disease-free Survival in Rectal Cancer Patients Undergoing Oncological Resective Surgery and Concomitant Bariatric Surgery

Peri-operative complications during rectal cancer surgery

Overall survival for patients with rectal cancer underwent resective surgery after BIB positioning

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Endoscopic Versus Surgical Treatment for T1 Colorectal Cancer	NCT04150081	Colorectal Canc...	Surgery or Endo...	-	Hospital Clinic of Barcelona
Chemotherapy Followed by Pelvic Reirradiation Versus Chemotherapy Alone as Pre-operative Treatment for Locally Recurrent Rectal Cancer	NCT03879109	Rectal Cancer	Chemotherapy FO... Radiochemothera... Surgery	18 Years -	University Hospital, Bordeaux
Influence of Early vs Late SPN on Long-term Quality of Life in ICU Patients After Gastrointestinal Oncological Surgery	NCT03699371	Nutrition Aspec...	Early Supplemen...	18 Years -	Medical University of Lublin
Evaluation of Surgical Complications and DFS in Obese Rectal Cancer Patients	NCT06056726	Obesity, Morbid Rectal Cancer Surgery-Complic...	BIB positioning	18 Years - 70 Years	Federico II University
Endoscopic Versus Surgical Treatment for T1 Colorectal Cancer	NCT04150081	Colorectal Canc...	Surgery or Endo...	-	Hospital Clinic of Barcelona

Spots Global Cancer Trial Database for oncological surgery