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Capecitabine-based Chemoradiotherapy in Combination With the IL-1 Receptor Antagonist Anakinra for Rectal Cancer Patients (ACO/ARO/AIO-21)

Primary Purpose

Rectal Cancer

Status
Recruiting
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Kineret 100 MG in 0.67 ML Prefilled Syringe
Capecitabine
Radiotherapy
Watch and Wait (cCR) or TME surgery (non-cCR)
Sponsored by
Goethe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female patients with histologically confirmed diagnosis of rectal adenocarcinoma localized 0 - 12 cm from the anocutaneous line as measured by rigid rectoscopy (i.e. lower and middle third of the rectum)
  • Staging requirements: High-resolution, thin-sliced (i.e. 3 mm) magnetic resonance imaging (MRI) of the pelvis is the mandatory local staging procedure.
  • Patients with MRI-defined low risk rectal cancer with the presence of at least one of the following conditions:

    • cT2N0 or cT3a/bN0 tumors ≤6 cm from the anocutaneous line that would require abdominoperineal resection or permanent colostomy
    • Any rectal cancer of the upper third (12-16 cm) requiring FU-CRT according to German S3 guideline recommendations (i.e. cT4, mrCRM+, extensive N+)
  • Patients with MRI-defined intermediate/high risk rectal cancer, but not eligible for TNT (oxaliplatin-containing) protocols:

    • any cT3 if the distal extent of the tumor is < 6 cm from the anocutaneous line, or
    • cT3c/d in the middle third of the rectum (≥ 6-12 cm) with MRI evidence of extramural tumor spread into the mesorectal fat of more than 5 mm (>cT3b), or
    • cT3 with clear cN1 based on strict MRI-criteria (see appendix)
    • cT4 tumors, or
    • Tany middle/low third of rectum with clear MRI criteria for N2
    • mrCRM+ (≤ 1mm), or
    • Extramural venous invasion (EMVI+)
  • Trans-rectal endoscopic ultrasound (EUS) is additionally used when MRI is not definitive to exclude early cT1 disease in the lower third or middle third of the rectum.
  • Spiral-CT of the abdomen and chest to exclude distant metastases.
  • Aged at least 18 years. No upper age limit
  • WHO/ECOG Performance Status ≤1
  • Adequate hematological, hepatic, renal and metabolic function parameters:

    • Leukocytes ≥ 3.000/mm^3, ANC ≥ 1.500/mm^3, platelets ≥ 100.000/mm^3, Hb > 9 g/dl
    • Serum creatinine ≤ 1.5 x upper limit of normal
    • Bilirubin ≤ 2.0 mg/dl, SGOT-SGPT, and AP ≤ 3 x upper limit of normal
  • Informed consent of the patient

Exclusion Criteria:

  • Distant metastases (to be excluded by CT scan of the thorax and abdomen)
  • Prior antineoplastic therapy for rectal cancer
  • Prior radiotherapy of the pelvic region
  • Major surgery within the last 4 weeks prior to inclusion
  • Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
  • Subject (male or female) is not willing to use highly effective methods of contraception during treatment and for 6 months after the end of treatment.
  • On-treatment participation in a clinical study in the period 30 days prior to inclusion
  • Previous or current drug abuse
  • Other concomitant antineoplastic therapy
  • Serious concurrent diseases, including neurologic or psychiatric disorders (incl. dementia and uncontrolled seizures), active, uncontrolled infections, active, disseminated coagulation disorder
  • Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 6 months before enrolment
  • Prior or concurrent malignancy ≤ 3 years prior to enrolment in study (Exception: non-melanoma skin cancer or cervical carcinoma FIGO stage 0-1), if the patient is continuously disease-free
  • Known allergic reactions on study medication
  • Known dihydropyrimidine dehydrogenase deficiency
  • Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule (these conditions should be discussed with the patient before registration in the trial).
  • History of severe hepatic impairment (e.g. Child-Pugh = Grade C)
  • Moderate (Creatinine Clearance 30 to 49 mL/minute), severe (Creatinine Clearance <30 mL/minute) renal impairment
  • Neutropenia (neutrophil count <1.5x109/l)
  • Known hypersensitivity to Anakinra or E. coli derived proteins, Anakinra or any of the components of the product
  • Asthma
  • Patients with clinically significant bacterial, fungal, parasitic or viral infection, which require acute therapy. Patients with acute bacterial infections requiring antibiotic use should delay screening/enrollment until the course of antibiotic therapy has been completed
  • Patients with known active hepatitis B, C or who are HIV-positive or who are at risk for HBV reactivation. At risk for HBV reactivation is defined as hepatitis B surface antigen positive or anti-hepatitis B core antibody positive. Prior test results obtained as part of standard of care that confirm a subject is immune and not at risk for reactivation (ie, hepatitis B surface antigen negative, surface antibody positive) may be used for purposes of eligibility and tests do not need to be repeated. Subjects with prior positive serology results must have negative polymerase chain reaction results. Subjects whose immune status is unknown or uncertain must have results confirming immune status before enrollment.
  • Subjects who are already using the following medications will not be allowed:

    • Tumor necrosis alpha inhibitors: Use on any of these biologics within 8 weeks of screening or baseline visit.
    • IL-6 inhibitors: Use of any IL-6 inhibitors within 8 weeks of screening or baseline visit
    • Janus Kinase inhibitors: Use of baricitinib, tofacinitib, upadacitinib, and ruxolitinib, oclacitinib, fedratinib, within 2 weeks from screening or baseline visit.
    • Bruton's tyrosine kinase inhibitors: Ibrutinib, acalabrutinib, zanubrutinib
    • CCR5 antagonist (CCR5 = C-C Chemokine Receptor Type 5; DMARD = Disease Modifying Anti-Rheumatic Drug): Leronlimab is also an immunomodulator.
    • DMARDs: cyclosporine, cyclophosphamide, mycophenolic acid, chlorambucil, penicillamine, azathioprine: Use within 6 months prior to screening or baseline visit.
    • Rituximab: Use of rituximab within 1 year of screening or baseline visit.
    • Abatacept: Use of abatacept within 8 weeks of screening or baseline visit.
  • Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation such as severe impaired lung functions as defined as spirometry and DLCO that is 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air
  • Patients under ongoing treatment with another investigational medication or having been treated with an investigational medication within 30 days (incl. live attenuated vaccine) of screening or 5 half-lives (whichever is longer) prior to the first dose of investigational product
  • Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed
  • History of any other disease, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug, or that might affect interpretation of the results of this study, or render the subject at high risk for treatment complications.

Sites / Locations

  • University Hospital Goethe University FrankfurtRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Chemoradiotherapy with Anakinra followed by either TME surgery or Watch and Wait

Arm Description

Capecitabine 500 mg/m2 bid or Capecitabine 650 mg/m2 bid or Capecitabine 825 mg/m2 bid combined with Radiotherapy and Kineret

Outcomes

Primary Outcome Measures

Analysis of safety for capecitabine administered concomitantly with standard radiotherapy in combination with Anakinra at a fixed dose of 100 mg s.c.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Identification of the maximum tolerated dose for capecitabine administered concomitantly with standard radiotherapy in combination with Anakinra at a fixed dose of 100 mg s.c
Identification of the maximum tolerated dose for capecitabine in combination with radiotherapy and Anakinra based on 3+3 design

Secondary Outcome Measures

Postoperative complications of (salvage) surgery
Postoperative complications of (salvage) surgery
Late toxicity assessment according to NCI CTCAE V.5.0
Late toxicity assessment according to NCI CTCAE V.5.0
Rate of W&W with or without local regrowth
Rate of W&W with or without local regrowth
Cumulative incidence of locoregional regrowth after cCR
cumulative incidence of locoregional regrowth after cCR
Rate of salvage surgery (LE/TME with or without APR/stoma) after locoregional regrowth
Rate of salvage surgery (LE/TME with or without APR/stoma) after locoregional regrowth
Cumulative incidence of local recurrence after (salvage) surgery
Cumulative incidence of local recurrence after (salvage) surgery
Cumulative incidence of distant recurrences
Cumulative incidence of distant recurrences
Disease-free survival
Disease-free survival
Overall survival
Overall survival
Pathological TNM-staging
Pathological TNM-staging based on TNM Classification of Malignant Tumors, 8th edition
R0 resection rate;
Rate of complete resection (R0)
negative circumferential resection rate
negative circumferential resection rate
Tumor regression grading according to Dworak
Tumor regression grading according to Dworak
Quality of TME according to MERCURY
Pathological tumor evaluations according to MERCURY classification
Quality of life based on treatment arm and surgical procedures/organ preservation
Quality of life based on EORTC-QLQs-C30
functional outcome based on treatment arm and surgical procedures/organ preservation
functional outcome based on Wexner score
Quality of life based on treatment arm and surgical procedures/organ preservation
Quality of life based on EORTC-QLQs-CR29
Quality of life based on treatment arm and surgical procedures/organ preservation
Quality of life based on EORTC-QLQs-CPIN20

Full Information

First Posted
May 25, 2021
Last Updated
August 23, 2022
Sponsor
Goethe University
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1. Study Identification

Unique Protocol Identification Number
NCT04942626
Brief Title
Capecitabine-based Chemoradiotherapy in Combination With the IL-1 Receptor Antagonist Anakinra for Rectal Cancer Patients
Acronym
ACO/ARO/AIO-21
Official Title
Capecitabine-based Chemoradiotherapy in Combination With the IL-1 Receptor Antagonist Anakinra for Rectal Cancer Patients. A Phase I Trial of the German Rectal Cancer Study Group
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 20, 2021 (Actual)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
July 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Goethe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The ACO/ARO/AIO-21 investigator-driven, open-labeled, phase I drug re-purposing trial will assess whether the IL-1 receptor antagonist Anakinra can be safely combined with fluoropyrimidine-based chemoradiotherapy (CRT) in patients with rectal cancer.
Detailed Description
Preoperative fluoropyrimidine-based chemoradiotherapy (CRT) and total mesorectal excision (TME) surgery 6-10 weeks thereafter, followed by optional adjuvant chemotherapy, has been the standard multimodal treatment for patients with UICC stage II and III rectal cancer during the last two decades. With this, pathological complete response rates (pCR) are in the range of 10%, 3 year-local failure rates in the range of 5%, distant recurrences occur in 25-30% of patients, and 3 years disease-free survival (DFS) amounts to 70%. More recently, total neoadjuvant treatment (TNT) with either 5x5 Gy or fluoropyrimidine-CRT, followed by consolidation chemotherapy with fluorouracil (or capecitabine) and oxaliplatin (FOLFOX/CAPOX), and TME, has significantly improved pCR and DFS compared to standard preoperative FU-CRT (+/- adjuvant chemotherapy) in recent phase 3 trials for patients with high-risk rectal cancer and has recently been accepted as standard treatment for this patient subgroup. In contrast, it remains unclear whether patients with intermediate risk rectal cancer benefit from TNT (currently under investigation in trials), whereas elderly and frail patients are not eligible for TNT and are rather be treated with 5x5 Gy or capecitabine-CRT alone. IL-1 is an inflammatory cytokine that plays a key role in tumor formation, progression and therapy resistance. Extensive studies of our group have showed that IL-1 mediates CRT resistance and disease progression in rectal cancer. Thus, blockade of IL-1 signaling using Anakinra constitutes an attractive option to significantly improve prognosis. The ACO/ARO/AIO-21 phase I drug re-purposing trial will assess whether the IL-1RA Anakinra can be safely combined with CRT in patients with rectal cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
3+3 design
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chemoradiotherapy with Anakinra followed by either TME surgery or Watch and Wait
Arm Type
Other
Arm Description
Capecitabine 500 mg/m2 bid or Capecitabine 650 mg/m2 bid or Capecitabine 825 mg/m2 bid combined with Radiotherapy and Kineret
Intervention Type
Drug
Intervention Name(s)
Kineret 100 MG in 0.67 ML Prefilled Syringe
Intervention Description
Anakinra 100 mg s.c. (Kineret) will be administered from day -10 (i.e. 10 days before initiation of RT) to the last day of RT.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
Capecitabine will be administered using a 3+3 dose escalation design (500 mg/m2 bid, 650 mg/m2 bid and 825 mg/m2 bid po, respectively) from day 1 to day 40 of RT including weekends.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
PTV: 1.8 Gy to 45 Gy (#28 fractions) to the primary tumor and pelvic lymph nodes; followed by a sequential boost of 1.8 Gy to 9 Gy (#5 fractions) to the gross tumor volume
Intervention Type
Procedure
Intervention Name(s)
Watch and Wait (cCR) or TME surgery (non-cCR)
Other Intervention Name(s)
W&W or TME
Intervention Description
Restaging to evaluate tumor response will be conducted 10 weeks after completion of CRT. For patients achieving a clinical complete response (cCR), a Watch and Wait (W&W) option with close follow-up is scheduled. In case of non-cCR, immediate total mesorectal excision (TME) surgery is recommended. According to the current German S3-guidelines, adjuvant chemotherapy is optional.
Primary Outcome Measure Information:
Title
Analysis of safety for capecitabine administered concomitantly with standard radiotherapy in combination with Anakinra at a fixed dose of 100 mg s.c.
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame
16 weeks
Title
Identification of the maximum tolerated dose for capecitabine administered concomitantly with standard radiotherapy in combination with Anakinra at a fixed dose of 100 mg s.c
Description
Identification of the maximum tolerated dose for capecitabine in combination with radiotherapy and Anakinra based on 3+3 design
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Postoperative complications of (salvage) surgery
Description
Postoperative complications of (salvage) surgery
Time Frame
1 year
Title
Late toxicity assessment according to NCI CTCAE V.5.0
Description
Late toxicity assessment according to NCI CTCAE V.5.0
Time Frame
3 years
Title
Rate of W&W with or without local regrowth
Description
Rate of W&W with or without local regrowth
Time Frame
3 years
Title
Cumulative incidence of locoregional regrowth after cCR
Description
cumulative incidence of locoregional regrowth after cCR
Time Frame
3 years
Title
Rate of salvage surgery (LE/TME with or without APR/stoma) after locoregional regrowth
Description
Rate of salvage surgery (LE/TME with or without APR/stoma) after locoregional regrowth
Time Frame
3 years
Title
Cumulative incidence of local recurrence after (salvage) surgery
Description
Cumulative incidence of local recurrence after (salvage) surgery
Time Frame
3 years
Title
Cumulative incidence of distant recurrences
Description
Cumulative incidence of distant recurrences
Time Frame
3 years
Title
Disease-free survival
Description
Disease-free survival
Time Frame
3 years
Title
Overall survival
Description
Overall survival
Time Frame
3 years
Title
Pathological TNM-staging
Description
Pathological TNM-staging based on TNM Classification of Malignant Tumors, 8th edition
Time Frame
3 years
Title
R0 resection rate;
Description
Rate of complete resection (R0)
Time Frame
3 years
Title
negative circumferential resection rate
Description
negative circumferential resection rate
Time Frame
3 years
Title
Tumor regression grading according to Dworak
Description
Tumor regression grading according to Dworak
Time Frame
3 years
Title
Quality of TME according to MERCURY
Description
Pathological tumor evaluations according to MERCURY classification
Time Frame
3 years
Title
Quality of life based on treatment arm and surgical procedures/organ preservation
Description
Quality of life based on EORTC-QLQs-C30
Time Frame
3 years
Title
functional outcome based on treatment arm and surgical procedures/organ preservation
Description
functional outcome based on Wexner score
Time Frame
3 years
Title
Quality of life based on treatment arm and surgical procedures/organ preservation
Description
Quality of life based on EORTC-QLQs-CR29
Time Frame
3 years
Title
Quality of life based on treatment arm and surgical procedures/organ preservation
Description
Quality of life based on EORTC-QLQs-CPIN20
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female patients with histologically confirmed diagnosis of rectal adenocarcinoma localized 0 - 12 cm from the anocutaneous line as measured by rigid rectoscopy (i.e. lower and middle third of the rectum) Staging requirements: High-resolution, thin-sliced (i.e. 3 mm) magnetic resonance imaging (MRI) of the pelvis is the mandatory local staging procedure. Patients with MRI-defined low risk rectal cancer with the presence of at least one of the following conditions: cT2N0 or cT3a/bN0 tumors ≤6 cm from the anocutaneous line that would require abdominoperineal resection or permanent colostomy Any rectal cancer of the upper third (12-16 cm) requiring FU-CRT according to German S3 guideline recommendations (i.e. cT4, mrCRM+, extensive N+) Patients with MRI-defined intermediate/high risk rectal cancer, but not eligible for TNT (oxaliplatin-containing) protocols: any cT3 if the distal extent of the tumor is < 6 cm from the anocutaneous line, or cT3c/d in the middle third of the rectum (≥ 6-12 cm) with MRI evidence of extramural tumor spread into the mesorectal fat of more than 5 mm (>cT3b), or cT3 with clear cN1 based on strict MRI-criteria (see appendix) cT4 tumors, or Tany middle/low third of rectum with clear MRI criteria for N2 mrCRM+ (≤ 1mm), or Extramural venous invasion (EMVI+) Trans-rectal endoscopic ultrasound (EUS) is additionally used when MRI is not definitive to exclude early cT1 disease in the lower third or middle third of the rectum. Spiral-CT of the abdomen and chest to exclude distant metastases. Aged at least 18 years. No upper age limit WHO/ECOG Performance Status ≤1 Adequate hematological, hepatic, renal and metabolic function parameters: Leukocytes ≥ 3.000/mm^3, ANC ≥ 1.500/mm^3, platelets ≥ 100.000/mm^3, Hb > 9 g/dl Serum creatinine ≤ 1.5 x upper limit of normal Bilirubin ≤ 2.0 mg/dl, SGOT-SGPT, and AP ≤ 3 x upper limit of normal Informed consent of the patient Exclusion Criteria: Distant metastases (to be excluded by CT scan of the thorax and abdomen) Prior antineoplastic therapy for rectal cancer Prior radiotherapy of the pelvic region Major surgery within the last 4 weeks prior to inclusion Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment. Subject (male or female) is not willing to use highly effective methods of contraception during treatment and for 6 months after the end of treatment. On-treatment participation in a clinical study in the period 30 days prior to inclusion Previous or current drug abuse Other concomitant antineoplastic therapy Serious concurrent diseases, including neurologic or psychiatric disorders (incl. dementia and uncontrolled seizures), active, uncontrolled infections, active, disseminated coagulation disorder Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 6 months before enrolment Prior or concurrent malignancy ≤ 3 years prior to enrolment in study (Exception: non-melanoma skin cancer or cervical carcinoma FIGO stage 0-1), if the patient is continuously disease-free Known allergic reactions on study medication Known dihydropyrimidine dehydrogenase deficiency Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule (these conditions should be discussed with the patient before registration in the trial). History of severe hepatic impairment (e.g. Child-Pugh = Grade C) Moderate (Creatinine Clearance 30 to 49 mL/minute), severe (Creatinine Clearance <30 mL/minute) renal impairment Neutropenia (neutrophil count <1.5x109/l) Known hypersensitivity to Anakinra or E. coli derived proteins, Anakinra or any of the components of the product Asthma Patients with clinically significant bacterial, fungal, parasitic or viral infection, which require acute therapy. Patients with acute bacterial infections requiring antibiotic use should delay screening/enrollment until the course of antibiotic therapy has been completed Patients with known active hepatitis B, C or who are HIV-positive or who are at risk for HBV reactivation. At risk for HBV reactivation is defined as hepatitis B surface antigen positive or anti-hepatitis B core antibody positive. Prior test results obtained as part of standard of care that confirm a subject is immune and not at risk for reactivation (ie, hepatitis B surface antigen negative, surface antibody positive) may be used for purposes of eligibility and tests do not need to be repeated. Subjects with prior positive serology results must have negative polymerase chain reaction results. Subjects whose immune status is unknown or uncertain must have results confirming immune status before enrollment. Subjects who are already using the following medications will not be allowed: Tumor necrosis alpha inhibitors: Use on any of these biologics within 8 weeks of screening or baseline visit. IL-6 inhibitors: Use of any IL-6 inhibitors within 8 weeks of screening or baseline visit Janus Kinase inhibitors: Use of baricitinib, tofacinitib, upadacitinib, and ruxolitinib, oclacitinib, fedratinib, within 2 weeks from screening or baseline visit. Bruton's tyrosine kinase inhibitors: Ibrutinib, acalabrutinib, zanubrutinib CCR5 antagonist (CCR5 = C-C Chemokine Receptor Type 5; DMARD = Disease Modifying Anti-Rheumatic Drug): Leronlimab is also an immunomodulator. DMARDs: cyclosporine, cyclophosphamide, mycophenolic acid, chlorambucil, penicillamine, azathioprine: Use within 6 months prior to screening or baseline visit. Rituximab: Use of rituximab within 1 year of screening or baseline visit. Abatacept: Use of abatacept within 8 weeks of screening or baseline visit. Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation such as severe impaired lung functions as defined as spirometry and DLCO that is 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air Patients under ongoing treatment with another investigational medication or having been treated with an investigational medication within 30 days (incl. live attenuated vaccine) of screening or 5 half-lives (whichever is longer) prior to the first dose of investigational product Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed History of any other disease, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug, or that might affect interpretation of the results of this study, or render the subject at high risk for treatment complications.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emmanouil Fokas, MD, DPhil
Phone
+49 (0)69 6301
Ext
5130
Email
emmanouil.fokas@kgu.de
First Name & Middle Initial & Last Name or Official Title & Degree
Claus Roedel, MD
Phone
+49 (0)69 6301
Ext
3742
Email
Studien-strahlen@kgu.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanouil Fokas, MD, DPhil
Organizational Affiliation
University Hospital Goethe University Frankfurt
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Goethe University Frankfurt
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanouil Fokas, MD DPhil
Phone
+49 69 6301
Ext
5130
Email
emmanouil.fokas@kgu.de
First Name & Middle Initial & Last Name & Degree
Claus Roedel, MD
Phone
+49 69 6301
Ext
3742
Email
studien-strahlen@kgu.de
First Name & Middle Initial & Last Name & Degree
Emmanouil Fokas, MD DPhil
First Name & Middle Initial & Last Name & Degree
Claus Roedel, MD

12. IPD Sharing Statement

Learn more about this trial

Capecitabine-based Chemoradiotherapy in Combination With the IL-1 Receptor Antagonist Anakinra for Rectal Cancer Patients

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