Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Prostatic Neoplasms

Vaginal Neoplasms

Endometrial Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urogenital Neoplasms

Genital Diseases

Urogenital Diseases

Genital Neoplasms, Female

Vaginal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Uterine Neoplasms

Uterine Diseases

Vaginal Cancer

(complete blood count, platelet count, renal function evaluation)

Biological investigations

Bone marrow is one of the organs at risk of complications during irradiation due to its radiosensitivity. Hematopoietic toxicity remains one of the main toxicities during irradiation of pelvic lymph node areas, especially when concomitant chemotherapy is used, volume of bone marrow irradiated is large and dose to the bone marrow is high. There is a lack of prospective studies and comparative trials to customize the constraints according to the presence or absence of chemotherapy and correlated to the patient's bone marrow potential. This multicentric and prospective study conducted by Strasbourg Europe Cancerology Institute aims to evaluate hematological toxicity (anemia, thrombocytopenia, leukopenia) in patients treated with pelvic irradiation for prostate, rectum, anal canal, endometrium, cervix cancer or vaginal cancer. One hundred patients will be included in the study, including patients treated with exclusive radiotherapy, radiochemotherapy, or radiohormonal therapy. The primary objective is to quantify the relationship between acute hematological toxicity and delivered doses and irradiated volumes in pelvic bone marrow for pelvic cancers. Hematological toxicity will be measured by weekly blood count during radiotherapy and at one month and three months after the end of radiotherapy. Secondary endpoints are the evaluation of viral, bacterial and fungal infections during and for three months following radiotherapy, as well as the evaluation of the impact of radiation-induced hematological toxicity on the administration of chemotherapy for the concerned patients. The aim of this study is to improve and optimize radiotherapy if a dose limit or volume constraint is imposed by the results of the study.

Patients will be identified as potentially eligible for inclusion once radiotherapy has been decided upon at the multidisciplinary consultation meeting. During the radiotherapy consultation, the study will be offered to the patient if they also meet the other inclusion criteria. As soon as the consent is signed and before the first radiotherapy session, a first biological check-up including a blood count and renal function will be performed. This biological investigation will serve as a reference.

During the dosimetric computer-tomography scan for radiotherapy, bony structures will be delineated, iliac bones, lower pelvis, femoral heads, lumbosacral spine and entire pelvis.

Dosimetry will be performed in the same way whether patients are included in the study or not, they will receive between 25Gy in 5 fractions and 78Gy in 39 fractions, depending on the primary tumor. The dose volume histograms will be received.

During treatment, patients will have a weekly blood test starting from the second week of treatment. At one months and three months after the end of the radiotherapy, patients will be seen in consultation and will also have a blood test.

Effect of Irradiation Doses < 10 Gy and of Irradiated Bone Volume on the Variation of Blood Elements of the Complete Blood Count During and After Pelvic Irradiation

* Haemoglobin
* Platelets
* Neutrophils
* Lymphocytes

Institut de cancérologie Strasbourg Europe

Digestive System Diseases

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Oxaliplatin

Capecitabine

Antimetabolites

Patients will receive 4 cycles of neoadjuvant CapOx chemotherapy (oxaliplatin 130 mg/m2 iv day 1, capecitabine 2000 mg/m2 bid per os days 1-14 every 3 weeks). In case of partial response or stable disease (based on pelvic MRI) patients proceed to surgery within 2 weeks. In case of disease progression patients receive 50 Gy pelvic chemoradiotherapy with capecitabine 825 mg/m2 bid per os on radiation days and then surgery following 8-10 weeks. After surgery patients receive 4 cycles of adjuvant CapOx chemotherapy (oxaliplatin 130 mg/m2 iv day 1, capecitabine 2000 mg/m2 bid per os days 1-14 every 3 weeks).

Patients will receive 5x5 Gy radiotherapy and then surgery following 6-8 weeks. After surgery patients receive 8 cycles of adjuvant CapOx chemotherapy (oxaliplatin 130 mg/m2 iv day 1, capecitabine 2000 mg/m2 bid per os days 1-14 every 3 weeks).

2000 mg/m2, bid, per os, days 1-14, 4 cycles

825 mg/m2, bid, per os, only on days of radiation (Monday through Friday)

Pelvic radiotherapy dose: 44 Gy on regional nodes, 50 Gy on primary tumor

Radiotherapy

Laparoscopic or open total mesorectal excision

Rectal cancer surgery

Pelvic radiotherapy dose: 25 Gy in 5 Gy fractions

Zaman Z Mamedli, PhD

The purpose of this study is to determine whether 3 months of neoadjuvant CapOx is non-inferior to neoadjuvant radiotherapy in patients with moderate risk CRM"-" mid rectal cancer.

This trial aims to investigate the efficacy of neoadjuvant chemotherapy compared to 5x5 Gy neoadjuvant radiotherapy in moderate risk CRM-negative rectal cancer patients. This is a prospective multicenter open-label non-inferiority randomized phase III clinical trial. Patients will be randomized using an online randomization system to receive either 4 cycles of neoadjuvant CapOx (oxaliplatin 130 mg/m2 iv day 1, capecitabine 2000 mg/m2 per os bid days 1-14) chemotherapy, surgery and 4 cycles of adjuvant CapOx chemotherapy or 5x5 Gy radiotherapy, surgery and 8 cycles of adjuvant CapOx chemotherapy. A stratification will be performed based on сN stage and clinical center. Patients with сT3c-T3dN0-1M0, cT1-T3dN2M0 cancer in the middle rectum are included. Chemoradiotherapy (50 Gy with concomitant capecitabine 825 mg/m2 per os bid on radiation days) will be performed for patients with tumor progression after neoadjuvant chemotherapy. The main hypothesis is that the 2-year local recurrence rate is non-inferior after neoadjuvant chemotherapy and neoadjuvant radiotherapy in moderate risk mid rectal cancer patients. The target accrual is 158 patients in each treatment arm (including 10% potential data loss) based on non-recurrence rate of 98% in investigated and 96% in the control group with a non-inferiority margin of 3%, α=0,05, power 80%. An interim analysis is planned after 50% of the patients will reach a 2-year followup. Pelvic Magnetic Resonance Imaging (MRI) is performed in all patients for staging before and after neoadjuvant chemotherapy and before surgery. Pelvic MRI is subject to central review. Conduction of this study and data collection are controlled by a local institutional board.

Neoadjuvant Chemotherapy in Patients With Moderate Risk Mid Rectal Cancer

A Multicenter Prospective Phase III Clinical Trial of Neoadjuvant CapOx in Patients With Intermediate Risk CRM-negative Middle Rectal Cancer

Proportion of patients who receive a complete course of adjuvant chemotherapy

Toxicity measured according to NCI-CTCAE v.5.0

Morbidity measured according to Clavien-Dindo classification

Proportion of patients with disease progression during neoadjuvant chemotherapy

The rate of tumor-associated complications (bowel obastruction, bleeding etc) during neoadjuvant chemotherapy

Blokhin's Russian Cancer Research Center

Principal Investigator, Consultant surgeon

Symptoms and General Pathology

Postoperative Complications

Patients offered surgery with the retractor sponge

Patients receiving standard care: surgery in Trendelenburg position

Compressed cellulose sponge for use in laparoscopic surgery to retract the intestines from the surgical field.

Sponge

Anke B Smits, MD

Alice M Couwenberg, BSc

Anke B Smits, MD/PhD

Johannes PM Burbach, MD

Helena M Verkooijen, MD/AssProf

Peter G Noordzij, MD/PhD

Onne Reerink, MD/PhD

Marco van Vulpen, MD/Prof

Laparoscopic surgery of the distal colon and rectum requires surgery with an appropriate field of view. A commonly used technique to create a clear exposure is the steep Trendelenburg position in which the patient is positioned in an angle of 15 to 40 degrees with the head down using the effect of gravity to retract the small intestine. This method is associated with haemostatic changes caused by the cranial shift of abdominal organs and blood. Recently, a cellulose compressed sponge was developed as intraoperative retractor, with the aim to keep the small intestines aside while the patient remains in a horizontal position. The safety of the sponge is secured with CE marking. The retractor sponge ensures a clear surgical field and potentially prevents haemostatic instability by avoiding Trendelenburg position. A pilot study in the St Antonius Hospital Nieuwegein has shown that use of the sponge might be associated with shorter hospital stay.

Objective: We study the efficacy of the retractor sponge in laparoscopic colorectal surgery to reduce hospital stay in patients operated for a malignancy. Secondary objectives are duration of surgery, blood-loss, use of diuretics as volume therapy (during surgery as wells as during total hospital stay), postoperative hypoxemia and peri- and postoperative complications.

Study design: Randomized controlled trial, nested within a prospective cohort according to the 'cohort multiple randomized controlled trial' (cmRCT) design.

Study population: Patients with colorectal cancer who undergo laparoscopic surgery, and who have given informed consent to be offered experimental interventions within the PICNIC project. Patient who require open surgery or patients with benign colorectal diseases are excluded for this study.

Intervention: Intraoperative use of the retractor sponge versus usual care, i.e. the Trendelenburg position.

Main study parameters/endpoints: The primary endpoint is length of hospital stay. Secondary endpoints are duration of surgery, blood-loss, use of diuretics (during surgery as wells as during total hospital stay), postoperative hypoxemia and peri- and postoperative surgical, pulmonary and cardiac complications.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The study will be conducted according to the cohort multiple Randomized Controlled Trial (cmRCT) design. Within the PICNIC cohort, we will identify all patients who are eligible for the experimental intervention (use of the sponge) and who have given informed consent to be invited for future experimental interventions. From this sub cohort, we will randomly select a group of patients to whom we will offer surgery with use of the retractor sponge, which they can accept or decline. Eligible patients from the sub cohort who were not randomly selected will undergo standard treatment, i.e. surgery in Trendelenburg position. We do not expect adverse events in patients in the intervention arm, besides dysfunction of the sponge, after which conversion to standard treatment (Trendelenburg position) needs to take place.

Trial for Retractor Sponge Evaluation in Laparoscopic Colorectal Surgery

Randomized Controlled Trial to Evaluate the Effect of a Retractor Sponge in Postoperative Hospital Stay in Laparoscopic Colorectal Surgery in Patients With Malignancy

St. Antonius Hospital

Dr. A.M. Smits

Patients receive 2 cycles of induction CapOx (oxaliplatin 130 mg/m2 iv day 1, capecitabine 2000 mg/m2 per os bid days 1-14) chemotherapy, followed by chemoradiotherapy (54 Gy in 2 Gy fractions with concomitant capecitabine 825 mg/m2 per os bid on radiation days), then 2 cycles of consolidation CapOx chemotherapy, surgery (10-12 weeks following chemoradiotherapy) and 2 cycles of adjuvant CapOx chemotherapy

Patients receive 54 Gy pelvic chemoradiotherapy in 2 Gy fractions with capecitabine 825 mg/m2 bid per os on radiation days and then surgery following 10-12 weeks. After surgery patients receive 6 cycles of adjuvant CapOx chemotherapy.

Pelvic radiotherapy dose: 44 Gy on regional nodes, 54 Gy on primary tumor in 2 Gy fractions

Laparoscopic or open total mesorectal excision or extralevator abdominoperineal resection

The purpose of this study is to determine whether the addition of 2 cycles of induction CapOx chemotherapy and 2 cycles of consolidation CapOx chemotherapy to standard chemoradiation improves 3-year disease-free survival in patients with locally advanced CRM"+" mid and low rectal cancer.

This trial aims to investigate the efficacy of adding neoadjuvant induction and consolidation chemotherapy compared to standard chemoradiotherapy in locally advanced rectal cancer patients with circumferential resection margin involvement. This is a prospective multicenter open-label randomized phase III clinical trial. Patients will be randomized using an online randomization system to receive either 2 cycles of induction CapOx (oxaliplatin 130 mg/m2 iv day 1, capecitabine 2000 mg/m2 per os bid days 1-14) chemotherapy, followed by chemoradiotherapy (54 Gy in 2 Gy fractions with concomitant capecitabine 825 mg/m2 per os bid on radiation days), then 2 cycles of consolidation CapOx chemotherapy, surgery (10-12 weeks following chemoradiotherapy) and 2 cycles of adjuvant CapOx chemotherapy OR chemoradiotherapy (54 Gy in 2 Gy fractions with concomitant capecitabine 825 mg/m2 per os bid on radiation days), surgery (10-12 weeks following chemoradiotherapy) and 6 cycles of adjuvant CapOx chemotherapy. A stratification will be performed based on N stage, tumor location in the middle or low rectum and clinical center. Patients with middle or low rectal cancer without distant metastases, with involved circumferential resection margin (based on pretreatment MRI) will be included.

The target accrual is 270 patients in each treatment arm (including 10% potential data loss) based on potential benefit of 12% 3-yr disease-free survival (60% vs 72%), α=0,05, power 80% in the experimental arm. An interim analysis is planned after 50% of the patients will reach a 3-year followup. Pelvic Magnetic Resonance Imaging (MRI) is performed in all patients for staging before and after neoadjuvant chemotherapy and before surgery. Pelvic MRI is subject to central review. Conduction of this study and data collection are controlled by a local institutional board.

Induction and Consolidation Chemotherapy in Patients With Locally Advanced CRM-positive Rectal Cancer

Induction and Consolidation Chemotherapy in Locally Advanced Rectal Cancer Patients With Circumferential Resection Margin Involvement: a Multicenter Prospective Randomized Phase III Clinical Trial

The rate of tumor-associated complications (bowel obstruction, bleeding etc) during neoadjuvant chemotherapy

Neoplasm Metastasis

Neoplastic Processes

Colonic Diseases

Hematinics

Herbal and Botanical

Antibodies

Immunoglobulins

Liver Extracts

Cola

Treatment: 930µg per treatment once weekly for 8 weeks, then at 6-week intervals during years 1 and 2.

L-BLP25

Treatment: Placebo 930µg per treatment, once weekly for 8 weeks, then at 6-week intervals during years 1 and 2.

Placebo

Carl Christoph Schimanski, Prof. Dr.

Comparative evaluation of recurrence-free survival (RFS) time and 3 year overall survival (OS) time between the treatment groups (L-BLP25 plus cyclophosphamide versus placebo and saline infusion).

This trial is designed for patients with metastatic colorectal carcinoma (CRC), who have undergone a complete resection of their primary tumor and recent resection of their liver metastases (R0 or R1) with curative intent. No generally accepted standard care is available following curative-intent resection of hepatic metastases in colorectal cancer patients. L-BLP25 is a cancer vaccine that targets MUC1, a well known tumor-associated antigen. Recently, it has been shown that MUC1 is associated with cellular transformation as demonstrated by tumorigenicity and can confer resistance to genotoxic agents. High levels of MUC1 cell surface expression, reported immunosuppressive activities of its released ectodomain, and anti-adhesive properties all contribute to the ability of the MUC1 antigen to protect and promote tumor cell growth and survival, and make MUC1 an attractive target for cancer immunotherapy.

Based on these results, L BLP25 may have potential as adjuvant therapy after curative resection of hepatic metastases in colorectal cancer patients.

L-BLP25 in Patients With Colorectal Carcinoma After Curative Resection of Hepatic Metastases

LICC: L-BLP25 in Patients With Colorectal Carcinoma After Curative Resection of Hepatic Metastases - a Randomized, Placebo-controlled, Multicenter, Multinational, Double Blinded Phase II Trial

The primary variable of this trial is recurrence free survival (RFS) time. RFS time will be measured from the date of randomization to the date of recurrence. For subjects not known to have experienced recurrence or death at the time of analysis, the time between the date of randomization and the date of last evaluation for recurrence will be calculated and used as a censored observation in the analysis.

Assessment of safety will include:

* AEs, SAEs
* Vital signs (body temperature, respiratory rate, heart rate, and blood pressure) and physical examinations,
* Clinical laboratory assessments from hematology and biochemistry samples

Recurrence free survival (RFS) time of MUC1 positive cancers will be measured from the date of randomization to the date of relapse based on standard imaging. For subjects not known to have experienced recurrence or death at the time of analysis, the time between the date of randomization and the date of last evaluation for recurrence or death will be calculated and used as a censored observation in the analysis.

Overall survival time of MUC1 positive cancers will be measured from the date of randomization to the date of death. For subjects not known to be deceased at the time of analysis, the time between the date of randomization and the date of last contact, or date lost to follow-up, will be calculated and used as a censored observation in the analysis.

Prof. Dr. Carl Schimanski

Coordinating Investigator

Patients will receive 4 cycles of neoadjuvant CapOx chemotherapy (oxaliplatin 130 mg/m2 iv day 1, capecitabine 2000 mg/m2 bid per os days 1-14 every 3 weeks). In case of partial response or stable disease (based on pelvic MRI) patients proceed to surgery. In case of disease progression patients receive 50 Gy pelvic chemoradiotherapy with capecitabine 825 mg/m2 bid per os on radiation days and then surgery. The decision to proceed with adjuvant chemotherapy postoperatively will be based on pTNM stage

Patients will receive standard surgery for rectal cancer with partial or total mesorectal excision (based on exact tumor location and surgeons discretion). The decision to proceed with adjuvant chemotherapy postoperatively will be based on pTNM stage

Laparoscopic or open partial or total mesorectal excision (based on exact tumor location and surgeons discretion)

The purpose of this study is to determine whether 4 cycles of neoadjuvant CapOx chemotherapy is more effective than the upfront surgery in patients with intermediate risk CRM"-" mid and upper rectal cancer.

This trial aims to investigate the efficacy of neoadjuvant chemotherapy compared to upfront surgery in intermediate risk rectal cancer patients. This is a prospective multicenter open-label randomized phase III clinical trial. Patients will be randomized using an online randomization system to receive either 4 cycles of neoadjuvant CapOx (oxaliplatin 130 mg/m2 iv day 1, capecitabine 2000 mg/m2 per os bid days 1-14) chemotherapy and surgery or surgery alone. A stratification will be performed based on N stage, tumor location in the middle or upper rectum and clinical center. Patients with cT3-4aN1-2M0, T4aN0M0 cancer in the upper rectum and сТ2-Т3bN1M0 (based on preoperative MRI) cancer in the middle rectum are included. All patients are potential candidates for adjuvant chemotherapy, according to preoperative staging. Chemoradiotherapy (50 Gy with concomitant capecitabine 825 mg/m2 per os bid on radiation days) will be performed for patients with tumor progression after neoadjuvant chemotherapy. The decision to proceed with adjuvant chemotherapy postoperatively will be based on pTNM stage in both treatment arms, according to actual treatment guidelines. The target accrual is 280 patients in each treatment arm (including 10% potential data loss) based on potential benefit of 10% 3-yr disease-free survival (75% vs 85%), α=0,05, power 80% in the experimental arm. An interim analysis is planned after 50% of the patients will reach a 3-year followup. Pelvic Magnetic Resonance Imaging (MRI) is performed in all patients for staging before and after neoadjuvant chemotherapy and before surgery. Pelvic MRI isbject to central review. Conduction of this study and data collection are controlled by a local institutional board.

Neoadjuvant Chemotherapy in Patients With Intermediate Risk Upper and Mid Rectal Cancer

A Multicenter Prospective Phase III Clinical Trial of Neoadjuvant CapOx Chemotherapy in Patients With Intermediate Risk Middle and Upper Rectal Cancer

Adenocarcinoma

Colonic Neoplasms

Liver Neoplasms

Liver Diseases

Stage 1: Four escalating dose cohorts of NV1020 3x10\^6 pfu, 1x10\^7 pfu, 3x10\^7 pfu, and 1x10\^8 pfu administered via hepatic artery infusion, over 10 minutes and repeated every 1-2 weeks for 4-8 weeks followed by 2 cycles of chemotherapy.

Stage 2: Expansion of one dose cohort from Stage 1 of optimal NV1020 dose administered via hepatic artery infusion, over 10 minutes and repeated every 1-2 weeks for 4-8 weeks followed by 2 cycles of chemotherapy.

NV1020 dose levels: 3x10\^6, 1x10\^7, 3x10\^7, and 1x10\^8 plaque forming units, administered via hepatic artery infusion, over 10 minutes and repeated every 1-2 weeks for 4-8 weeks

NV1020

Hoda Tawfik, PhD

This study is an open-label study. It has two stages. Stage 1 is a dose escalation phase of the study to determine and evaluate the safety and tolerability of repeated treatments with a genetically engineered herpes simplex virus NV1020 administered locoregionally to the liver.

Stage 2 is to evaluate the dose found in Stage 1 to be "optimally tolerated". Stage 2 is to assess the efficacy of the optimally tolerated dose of NV1020 by itself and in combination with second-line chemotherapy.

Assignment to Stage 1 or Stage 2 of the study is determined by when the patient enters the study.

This study is designed to evaluate the effects of repeated treatments with NV1020, prior to second-line chemotherapy, and to determine an appropriate dose level of NV1020 in a multiple dose regimen for later Phase II studies.

Sequential, open-label cohort dose escalation of NV1020 (stage 1) followed by an expansion of one selected dose cohort (stage 2).

Study results will be reviewed periodically by an independent DSMB who will approve each cohort dose escalation.

During the dose escalation stage, 3 cohorts of patients (3 in each) will be treated with 4 fixed doses of NV1020, with the dose level increasing for successive cohorts. A patient will be observed for a minimum of 7 days after the first NV1020 infusion before the next patient in the same cohort is given NV1020. The first patient in the next higher dose cohort will receive NV1020 no earlier than 14 days after the last patient in the prior cohort has finished NV1020 infusions. One additional cohort (half log higher increment) may be approved by the DSMB, if considered necessary to define MTD. Dose-limiting toxicity will be determined using NCI CTC criteria and a suitable dose level for later evaluation will be selected.

In the second stage of the study, the dose cohort considered to show the best therapeutic index will be expanded by the addition of 18 further patients. For all patients in this study, investigational treatment with NV1020 will be followed by a minimum of two cycles of second-line therapy using anti-neoplastic drugs approved by the FDA for colorectal cancer and selected by the investigator.

All patients will be followed up periodically until death. Permission for autopsy will be sought.

Safety & Efficacy of NV1020 in Colorectal Cancer Metastatic to the Liver

A Phase I/II, Open-label Study to Evaluate the Safety and Anti-tumor Effects of NV1020 Administered Repeatedly Via Hepatic Artery Infusion Prior to Second-line Chemotherapy, in Patients With Colorectal Adenocarcinoma Metastatic to the Liver

Incidence of adverse events for all patients (N=32); Overall incidence ≥20%; Adverse events listed by Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term

Number of patients with NV1020 detected in saliva, skin, and/or mucosal surfaces; Analysis by polymerase chain reaction (PCR)

Number of patients with clinically significant hematology laboratory abnormalities by NV1020 dose cohort (Post baseline)

Number of patients with post-baseline clinically significant laboratory chemistry abnormalities by NV1020 dose cohort

Number of patients with post-baseline clinically significant laboratory coagulation abnormalities by NV1020 dose cohort

Maximum percentage changes in tumor diameter after administration of NV1020 followed by chemotherapy as measured by CT scan and Modified Response Evaluation Criteria in Solid Tumors (RECIST) assessment

Mean change from baseline in NV1020 neutralizing antibody titer by dose cohort

Progression assessed from CT and PET measurements and is determined as an increase of greater than or equal to 25% in the sum of the products of perpendicular diameters of all tumors, or the appearance of any new lesion.

Median change from baseline of Interferon (INF) gamma 8 hours post NV1020 infusion (Visits 1, 3, 5, 7)

Median change from baseline of Interleukin-6 (IL-6) 8 hours post NV1020 infusion (Visits 1, 3, 5, 7)

Median change from baseline of tumor necrosis factor (TNF-alpha) 8 hours post NV1020 infusion (Visits 1, 3, 5, 7)

MediGene

\*Serious adverse events exclude those which were deemed to be unrelated to NV1020

Escalating doses of NV1020: 3x10\^6, 1x10\^7, 3x10\^7, 1x10\^8

Age, Continuous

Sex: Female, Male

Caucasian

African American

Asian

Hispanic

Race/Ethnicity, Customized

Carcinoembryonic Antigen (CEA) Level at Screening

Prior Chemotherapy

KPS 100

KPS 90

KPS 80

The KPS was rated as follows:

100 - Normal, no complaints, no evidence of disease; 90 - Able to carry on normal activity; minor signs or symptoms of disease; 80 - Normal activity with effort; some signs or symptoms of disease

Karnofsky Performance Status (KPS)

Associate Director Regulatory Affairs

Dose limiting adverse events

Nausea

Abdominal pain

Diarrhea

Vomiting

Abdominal pain upper

Constipation

Pyrexia

Chills

Fatigue

Edema peripheral

Back pain

Headache

Anemia

Neutropenia

Rash

Hypokalemia

Insomnia

All Patients

Incidence of Adverse Events and Dose Limiting Adverse Events

Mean Baseline CEA

Mean Change - Chemo visit 1

Mean Change - Chemo visit 2

Mean Change - Follow-up 1

Mean Change - Follow-up 2

Mean Change - Follow-up 3

Mean Change - Follow-up 4

Dose Cohort 1

Dose Cohort 2

Dose Cohort 3

Dose Cohort 4

Number of participants analyzed decreases through the follow-up visits. Thus the "Number of Participants Analyzed" indicated here refer to the number at baseline.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Irradiation Doses < 10 Gy and of Irradiated Bone Volume on the Variation of Blood Elements of the Complete Blood Count During and After Pelvic Irradiation	NCT04626466	Prostate Carcin... Rectum Carcinom... Anal Canal Carc... Endometrium Car... Cervix Carcinom... Radiotherapy Vaginal Cancer	Biological inve...	18 Years - 79 Years	Institut de cancérologie Strasbourg Europe
Neoadjuvant Chemotherapy in Patients With Moderate Risk Mid Rectal Cancer	NCT04134897	Rectal Neoplasm... Rectum Carcinom... Rectal Cancer	Capecitabine Oxaliplatin Capecitabine Radiotherapy Rectal cancer s... Radiotherapy	18 Years - 75 Years	Blokhin's Russian Cancer Research Center
Trial for Retractor Sponge Evaluation in Laparoscopic Colorectal Surgery	NCT03334383	Colon Carcinoma Rectum Carcinom...	Sponge	18 Years - 95 Years	St. Antonius Hospital
Induction and Consolidation Chemotherapy in Patients With Locally Advanced CRM-positive Rectal Cancer	NCT04135313	Rectal Neoplasm... Rectum Carcinom... Rectal Cancer	Capecitabine Oxaliplatin Capecitabine Radiotherapy Rectal cancer s...	18 Years - 75 Years	Blokhin's Russian Cancer Research Center
L-BLP25 in Patients With Colorectal Carcinoma After Curative Resection of Hepatic Metastases	NCT01462513	Colon Carcinoma Rectum Carcinom...	L-BLP25 Placebo	18 Years - 120 Years	Johannes Gutenberg University Mainz
L-BLP25 in Patients With Colorectal Carcinoma After Curative Resection of Hepatic Metastases	NCT01462513	Colon Carcinoma Rectum Carcinom...	L-BLP25 Placebo	18 Years - 120 Years	Johannes Gutenberg University Mainz
Neoadjuvant Chemotherapy in Patients With Intermediate Risk Upper and Mid Rectal Cancer	NCT04103697	Rectal Neoplasm... Rectum Carcinom... Rectal Cancer	Capecitabine Oxaliplatin Capecitabine Radiotherapy Rectal cancer s...	18 Years - 70 Years	Blokhin's Russian Cancer Research Center
Safety & Efficacy of NV1020 in Colorectal Cancer Metastatic to the Liver	NCT00149396	Colorectal Canc... Liver Neoplasms	NV1020	18 Years -	MediGene
Safety & Efficacy of NV1020 in Colorectal Cancer Metastatic to the Liver	NCT00149396	Colorectal Canc... Liver Neoplasms	NV1020	18 Years -	MediGene
Mechanical Bowel Preparation and Oral Antibiotics Versus Mechanical Bowel Preparation Only Prior Rectal Surgery	NCT04281667	Rectal Adenocar... Rectum Neoplasm Rectum Carcinom... Colorectal Canc... Colorectal Neop... Colorectal Carc... Surgical Site I... Surgery--Compli...	Oral Antibiotic... Placebo Mechanical Bowe...	18 Years -	Helsinki University Central Hospital

Spots Global Cancer Trial Database for rectum carcinoma