Trial Title:
The Radiation Oncology-Biology Integration Network (ROBIN) Molecular Characterization Trial (MCT) of Standard Short Course Radiotherapy for Rectal Cancer
NCT ID:
NCT05943210
Condition:
Rectal Cancer
Conditions: Official terms:
Rectal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
This is a molecular characterization trial (MCT) of 25 consecutively treated rectal
cancers with short-course radiotherapy (scRT; 25Gy/5 fractions). Tissue and imaging will
be collected at three time-points: 1. Baseline (day -28 to 0) - pelvic MRI and CT,
research biopsy, blood (50ml), stool. 2. After 5 RT fractions (day 5-10) - CT, research
biopsy, blood (50ml), stool 3. At time of surgery (wk 6) - MRI and CT, surgical tumor and
nodal specimens, blood (50ml), stool.
Primary purpose:
Basic Science
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Short Course Radiation Therapy (scRT)
Description:
Eligible patients will receive short course radiation therapy (scRT) of 25Gy over 5 days
(fractions) for their localized rectal cancer. Research bloods stool and tissue will be
collected at three time points: Baseline, end of radiation therapy and at surgery.
Arm group label:
Single cohort
Intervention type:
Procedure
Intervention name:
Total Mesenteric Excision (TME)
Description:
Subjects are expected to undergo total mesenteric Excision(TME) even if subjects have
achieved complete response by imaging.TME is a specific surgical technique used in the
treatment of rectal cancer in which the bowel with the tumor is entirely removed along
with surrounding fat and lymph nodes.
Arm group label:
Single cohort
Summary:
This trial (molecular characterization trial) focuses on rectal cancer, a common cancer
that is treated with radiotherapy (RT) as standard of care and represents a setting in
which to study the effects of RT on the immune system.
Detailed description:
The study aims to test the hypothesis that the radiation therapy will assist in targeting
the rectal cancer by mounting a robust immune response against the rectal cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically confirmed diagnosis of adenocarcinoma of the rectum
- Age ≥ 18 years
- ECOG performance status 0-1
- cT2-T3N0 or cT1-3N1
- Rectal cancer amenable to total mesorectal excision
- No evidence of distant metastases
- No prior pelvic radiation therapy
- No prior chemotherapy or surgery for rectal cancer
- No infections requiring systemic antibiotic treatment
- Hgb >8.0 gm/dL, PLT > 150,000/mm3, total bilirubin ≤ 1.5x upper limit of normal, AST
≤ upper limit of normal, ALT ≤ 3x upper limit of normal
- Patients must read, agree to, and sign a statement of informed consent prior to
participation in this study. Patients who do not read or understand English or
eligible but must have the consent form read to them in its entirety by an official
translator. Informed consent for non-literate or non-English speaking patients may
not be obtained by using a relative or a member of the patient's clinical team as a
translator.
- Female participants or reproductive potential, defined as not surgically sterilized
and between menarche and 1 year post menopause, must have a negative serum pregnancy
test within 4 weeks prior to initiation of study treatment.
- Women with childbearing potential who are negative for pregnancy (urine or blood)
and who agree to use effective contraceptive methods. A woman of childbearing
potential is defined by one who is biologically capable of becoming pregnant.
Reliable contraception should be used from trial screening and must be continued
throughout the study.
Exclusion Criteria:
- Recurrent rectal cancer
- Primary unresectable rectal cancer is defined as a primary rectal tumor which, on
the basis of either physical exam or pelvic MRI, is deemed to be adherent or fixed
to adjacent pelvic structures (en bloc resection will not be achieved with negative
margins).
- cT4 will be excluded.
- ≥4 regional lymph nodes each ≥10 mm on pelvic MRI
- Patients who have received prior pelvic radiotherapy
- Patients with prior allogenic stem cell or solid organ transplantation.
- Patients receiving treatment with systemic immunosuppressive medication (including,
but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate,
thalidomide, and antitumor necrosis factor-α agents) administered at >10 mg/day
prednisone or equivalent within 2 weeks prior to initiation of study treatment.
- Patients with any other concurrent medical or psychiatric condition or disease
which, in the investigator's judgment would make them inappropriate candidates for
entry into this study
- Patients receiving other anticancer or experimental therapy. No other experimental
therapies (including chemotherapy, radiation, hormonal treatment, antibody therapy,
immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, matrix
metalloprotease inhibitors, thalidomide, anti-VEGF/Flk-1 monoclonal antibody, or
other experimental drugs) of any kind are permitted while the patient is receiving
study treatment.
- Women who are pregnant or breastfeeding. Women of childbearing potential who are
unwilling or unable to use an acceptable method of birth control to avoid pregnancy
for the entire study period and for up to four weeks after the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The University of Chicago
Address:
City:
Chicago
Zip:
60637
Country:
United States
Status:
Recruiting
Contact:
Last name:
Fauzia Arif
Email:
farif@uchicagomedicine.org
Investigator:
Last name:
Sean Pitroda, M.D.
Email:
Principal Investigator
Facility:
Name:
Rutgers Cancer Institute of New Jersey
Address:
City:
New Brunswick
Zip:
08901
Country:
United States
Status:
Recruiting
Contact:
Last name:
ManiDeepika Katta
Phone:
732-427-6212
Email:
mk1570@cinj.rutgers.edu
Investigator:
Last name:
Salma Jabbour, M.D.
Email:
Principal Investigator
Facility:
Name:
New York Presbyterian Brooklyn Methodist Hospital
Address:
City:
Brooklyn
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Izael Nino
Email:
izn4001@med.cornell.edu
Contact backup:
Last name:
Mary Palmer
Email:
map9505@med.cornell.edu
Investigator:
Last name:
Hani Ashamalla, M.D.
Email:
Principal Investigator
Facility:
Name:
Weill Cornell Medical College
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Maahi Patel
Phone:
646-962-3118
Email:
map4044@med.cornell.edu
Contact backup:
Last name:
Fabiana Gregucci, M.D.
Phone:
646-962-2199
Email:
fgr4002@med.cornell.edu
Investigator:
Last name:
Encouse Golden, M.D., Ph.D.
Email:
Principal Investigator
Facility:
Name:
New York Presbyterian Hospital - Queens
Address:
City:
New York
Zip:
11355
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Hina Ali, M.D.
Phone:
718-670-1541
Email:
hia4002@med.cornell.edu
Contact backup:
Last name:
Krystalle Lyons
Phone:
718-670-1574
Email:
krl4003@med.cornell.edu
Investigator:
Last name:
Andrew Brandmaier, M.D.
Email:
Principal Investigator
Start date:
May 22, 2023
Completion date:
May 31, 2028
Lead sponsor:
Agency:
Weill Medical College of Cornell University
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Weill Medical College of Cornell University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05943210
