DRKS00025477
Completed
Phase 1
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 - ACO/ARO/AIO-21
niversitätsklinikum Frankfurt Goethe-Universität Frankfurt am Main0 sites12 target enrollmentJune 22, 2021
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- C20
- Sponsor
- niversitätsklinikum Frankfurt Goethe-Universität Frankfurt am Main
- Enrollment
- 12
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
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
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
Outcomes
Primary Outcomes
Not specified
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