Trial Title:
Preoperative Sequential Short-course Radiation Therapy and FOLFOX for Locally Advanced Rectal Cancer
NCT ID:
NCT05673772
Condition:
Rectal Cancer
Conditions: Official terms:
Rectal Neoplasms
Conditions: Keywords:
Rectal cancer
Neoadjuvant treatment
short-course radiotherapy
Consolidation chemotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
short-course radiotherapy
Description:
25 Gy in 5 fractions for 5 days
Arm group label:
Study group
Intervention type:
Drug
Intervention name:
mFOLFOX6
Description:
Oxaliplatin 85 mg/m2, Levoleucovorin 200mg (or Leucovroin, Leucosodium 400mg)/m2, 5- FU
400 mg/m2, and continuous 5- FU 2,400 mg/m2 for 46 hours
Arm group label:
Study group
Intervention type:
Radiation
Intervention name:
Chemoradiotherapy
Description:
45~50.4 Gy/25fr with concurrent use of either capecitabine or 5-FU+leucovorin(or
levoleucovorin or leucosodium)
Arm group label:
Control group
Intervention type:
Procedure
Intervention name:
TME surgery
Description:
TME surgery
Arm group label:
Control group
Arm group label:
Study group
Summary:
The treatment protocol proposed in this study is to perform short-term radiation therapy
and 4 cycles of FOLFOX chemotherapy for neoadjuvant treatment of locally advanced rectal
cancer. Compared to conventional chemoradiation therapy, the preoperative radiotherapy
period is shortened, and the cure rate of rectal cancer patients can be improved by early
treatment of micrometastasis using systemic chemotherapy. The patients who are assigned
to the study group will received the short-course radiotherapy and 4 cycles of FOLFOX and
patients in the control will received conventional chemoradiotherapy for preoperative
treatment. All patients are recommended to receive total mesorectal excision (TME) after
neoadjuvant treatment and adjuvant chemotherapy will be given according to the
pathological stage.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Asian
- ECOG (Eastern Cooperative Oncology Group) performance status 0-2
- Pathologically confirmed rectal cancer (rectal cancer located 10 cm or low from the
anal verge in pelvis MRI)
- Histologic type: adenocarcinoma, mucinous carcinoma, and signet ring cell carcinoma
- Locally advanced rectal cancer with one or more of the following factors based on
pelvis MRI: cTanyN1-2, cT3-4N0, or presence of extramural vascular invasion
- MRI findings such as pelvic lymph node metastasis, anal sphincter invasion, and T4b
are not included in the exclusion criteria, which cases will be enrolled by the
researcher's discretion
- Patients with appropriate organ (bone marrow, kidney, liver) function
- A person who understands the study and willing to provide informed consent
Exclusion Criteria: (one of the following criteria)
- Colon cancer or rectal cancer located more than 10 cm from the anal verge
- Stage I rectal cancer (clinical stage cT1-2N0)
- Clinically or pathologically diagnosed distant metastasis (cTanyNanyM1)
- Familial adenomatous polyposis
- Hereditary nonpolyposis colorectal cancer
- History of chemotherapy or radiotherapy within 6 months
- History of colorectal cancer or other type of malignancy within 5 years (except for
cured nonmelanoma skin or in situ cervical cancer)
- Comorbidities that make it difficult to undergo chemotherapy or radiotherapy
- Bone marrow suppression with neutrophil count <2 ×109/L or platelet count <100
×109/L prior to the first chemotherapy
- Peripheral sensory neuropathy with functional impairment (grade 2 or higher)
- Severe renal dysfunction (GFR ≤30ml/min by Wright or Cockroft formula)
- Severe hepatic dysfunction
- Genetic problems such as galactose intolerance, Lapp lactase deficiency or
glucose-galactose malabsorption
- Taking tegafur, gimeracil, and oteracil potassium complex and those within 7 days of
discontinuation
- Taking sorivudine or brivudine
- Significant heart disease or myocardial infarction within the last 6 months
- Hereditary diseases or history of coagulopathy
- Central nervous system disorders with disability or mental disorders
- Pregnant or lactating women
- Currently participating in other clinical trials or receiving research medication
- Unhealed wounds, fractures, peptic ulcer, abscesses in the abdominal cavity
- Active gastrointestinal bleeding
- Active infections requiring antibiotics for injection
- Emergency Surgery
- History of hypersensitivity to the drugs in study protocol
- Patients with non-malignant tumor diseases
- Dihydropyrimidine dehydrogenase deficiency
- Not willing to participate
Gender:
All
Minimum age:
20 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Gyu seog Choi
Address:
City:
Daegu
Zip:
702-210
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Soo Yeun Park, M.D.
Phone:
+82-53-200-2166
Email:
psy-flower@daum.net
Facility:
Name:
Chungnam National University Hospital
Address:
City:
Daejeon
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Kyung Ha Lee, M.D.
Email:
lllllkh@cnuh.co.kr
Facility:
Name:
Chonnam National University Hwasun Hospital
Address:
City:
Gwangju
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Chang Hyun Kim, M.D.
Facility:
Name:
Catholic University of Korea Incheon St. Mary's Hospital
Address:
City:
Incheon
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Moon Jin Kim, M.D.
Email:
ch1j8g@naver.com
Facility:
Name:
Jeonbuk National University Hospital
Address:
City:
Jeonju
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Gi Won Ha, M.D.
Email:
acts29@jbnu.ac.kr
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
In Ja Park, M.D.
Email:
ipark@amc.seoul.kr
Investigator:
Last name:
In Ja Park, MD
Email:
Principal Investigator
Facility:
Name:
, Korea University Anam Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Ji-Seon Kim, M.D.
Email:
gsjskim621@korea.ac.kr
Facility:
Name:
Gangnam Severance Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Eun Jung Park, M.D.
Email:
CAMP79@yuhs.ac
Facility:
Name:
Seoul National University Bundang Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Hong-Min Ahn, M.D.
Email:
markahn85@gmail.com
Start date:
October 23, 2020
Completion date:
December 31, 2029
Lead sponsor:
Agency:
Kyungpook National University Hospital
Agency class:
Other
Collaborator:
Agency:
National Cancer Center, Korea
Agency class:
Other
Source:
Kyungpook National University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05673772
