Rectal Cancer Clinical Trial
Official title:
Randomized Phase II Study of SOX vs mFOLFOX6 as Neoadjuvant Chemotherapy in Patients With Resectable Rectal Cancer (KSCC1301).
To evaluate the efficacy and safety of SOX or mFOLFOX6 as neoadjuvant chemotherapy in patients with resectable rectal cancer, and to identify the more promising regimen.
1. Patient registration procedure
If it is confirmed that the subject meets the inclusion criteria and correspondent none of
the exclusion criteria, the subject is registered by using CReS Kyushu
registration/allocation system (CK-RAS). The registration with CK-RAS is available for 24hr
(URL: https://reg.cres-kyushu.or.jp/qmin/login/) and needs for individual ID and password.
2. Quality management
1. Monitoring
A central monitoring or in-site monitoring are carried out based on the data from case
report form (CRF) collecting at data coordinating center. In principle, an on-site
monitoring is not carried out, but it may be carried out when the on-site monitoring is
determined to need by Kyushu Study group of Clinical Cancer (KSCC) steering committee
from the results of the central monitoring so on.
2. Data Monitoring Committee
A Data Monitoring Committee (DMC) has been established.
3. Data entry
All data will be entered by the double entry method. Referential data rules, valid
values, range checks, and consistency checks against data already stored in the
database will be supported. Checks will be applied at the time of data entry into a
specific field. Additional errors will be detected by programs designed to detect
missing data or specific errors in the data. The investigator who receives the inquiry
will respond by checking the original forms for inconsistency, checking other sources
to determine the correction, modifying the original paper form entering a response to
the query.
4. Regular monitoring report
A regular monitoring report generated by data coordinating center is submitted to KSCC
Steering Committee, principal investigator, the DMC etc and it is reviewed according to
"KSCC regulation on the monitoring". The information on the status of site EC approval
and the achievement of enrollment: number of enrollment- total/per periodical,
total/per site, is reported monthly using e-mail.
- Contents of monitoring report
1. Study abstract: schema/purpose/subject/endpoint/definition of
treatment/anticipated enrollment number/progress of the study
2. Enrollment status: per participating site/total
3. Monitoring activity: contents of activity/CRF collection per site/uncollected
CRF, inquiry
4. Review of the eligible treatment caseļ¼the case of ineligible possibility/the
case determined as ineligible/number of eligible case/the case determined as
non-treatment/total number of treatment case
5. Review of a target population for analysis: the number of cases targeted for
efficacy analysis/safety analysis
6. Patient background
7. Treatment time-course: summary of on-treatment and discontinuation/summary of
reason for discontinuation/list of reason for discontinuation
8. Protocol violation/deviation
9. Safety evaluation: serious adverse reaction, event/the case which was
notified to the study group among the adverse reactions, events with an
ordinary report/general adverse events
10. Others
5. Audit
A site audit is carried out by the audit members of KSCC Coordinating Center, data
coordinating center, medical staff of other site under the approval of the site director
according to "KSCC regulation for site audit". The results of the audit are reported to the
site director, KSCC Steering Committee, principal investigator etc. (if required, to DMC).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05551052 -
CRC Detection Reliable Assessment With Blood
|
||
Recruiting |
NCT04323722 -
Impact of Bladder Depletion on Mesorectal Movements During Radiotherapy in Rectal Cancer
|
N/A | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04088955 -
A Digimed Oncology PharmacoTherapy Registry
|
||
Active, not recruiting |
NCT01347697 -
Collagen Implant (Biological Mesh) Versus GM Flap for Reconstruction of Pelvic Floor After ELAPE in Rectal Cancer
|
N/A | |
Recruiting |
NCT04495088 -
Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer
|
Phase 3 | |
Withdrawn |
NCT03007771 -
Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia
|
Phase 1 | |
Terminated |
NCT01347645 -
Irinotecan Plus E7820 Versus FOLFIRI in Second-Line Therapy in Patients With Locally Advanced or Metastatic Colon or Rectal Cancer
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT03520088 -
PROSPECTIVE CONTROLLED AND RANDOMIZED STUDY OF THE GENITOURINARY FUNCTION AFTER RECTAL CANCER SURGERY IN RELATION TO THE DISSECTION OF THE INFERIOR MESENTERIC VESSELS
|
N/A | |
Recruiting |
NCT05556473 -
F-Tryptophan PET/CT in Human Cancers
|
Phase 1 | |
Recruiting |
NCT04749381 -
The Role of TCM on ERAS of Rectal Cancer Patients
|
Phase 2 | |
Enrolling by invitation |
NCT05028192 -
Mitochondria Preservation by Exercise Training: a Targeted Therapy for Cancer and Chemotherapy-induced Cachexia
|
||
Recruiting |
NCT03283540 -
Transanal Total Mesorectal Excision for Rectal Cancer on Anal Physiology + Fecal Incontinence
|
||
Completed |
NCT04534309 -
Behavioral Weight Loss Program for Cancer Survivors in Maryland
|
N/A | |
Recruiting |
NCT05914766 -
An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer
|
N/A | |
Recruiting |
NCT04852653 -
A Prospective Feasibility Study Evaluating Extracellular Vesicles Obtained by Liquid Biopsy for Neoadjuvant Treatment Response Assessment in Rectal Cancer
|
||
Recruiting |
NCT03190941 -
Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients
|
Phase 1/Phase 2 | |
Completed |
NCT02810652 -
Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection
|
N/A | |
Terminated |
NCT02933944 -
Exploratory Study of TG02-treatment as Monotherapy or in Combination With Pembrolizumab to Assess Safety and Immune Activation in Patients With Locally Advanced Primary and Recurrent Oncogenic RAS Exon 2 Mutant Colorectal Cancer
|
Phase 1 | |
Active, not recruiting |
NCT02438839 -
Curative Chemoradiation of Low Rectal Cancer
|