Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
NCT number |
NCT06048146 |
Other study ID # |
LC2022L01 |
Secondary ID |
|
Status |
Enrolling by invitation |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 1, 2022 |
Est. completion date |
September 1, 2029 |
Study information
Verified date |
July 2023 |
Source |
Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The goal of this clinical trial is to compare in newly diagnosed patients with resectable
rectal cancer with lateral lymph node metastasis. This study aims to
- further verify the safety and efficacy of FOLFOXIRI three-drug regimen
- Using multiple omics techniques to identify and confirm specific molecular markers
Participants will be treated with FOLFOXIRI three-drug combination regimen. Researchers
will compare another group treated with conventional preoperative chemoradiotherapy to
see if the experimental group is superior to the control group in terms of 3-year
disease free survival, local recurrence rate, lateral lymph node positivity rate, and
5-year overall survival rate.
Description:
The goal of this clinical trial is to compare in newly diagnosed patients with resectable
rectal cancer with lateral lymph node metastasis. The main questions it aims to answer are:
- Evaluate the effectiveness and safety of Forfoxiri combined with lateral lymph node
dissection, and optimize the treatment plan for rectal cancer patients with resectable
lateral lymph node metastasis.
- Using multiple omics techniques to identify and confirm specific molecular markers for
chemotherapy response, lateral lymph node metastasis, and distant metastasis in rectal
cancer, in order to achieve the goal of precise treatment of lateral lymph node
metastasis Participants will
- receive three cycles of chemotherapy with FOLFOXIRI regimen, and the specific dose was:
irinotecan 150mg/m2, d1, Oxaliplatin 85mg/m2, d1, 5-Fu, 2400mg/m2, continuously pumped
for 46 hours, repeated for 14 days.
- After 3 cycles of chemotherapy, rectal MRI reexamination was performed, and the efficacy
was evaluated using the RECIST method.
- For cCR or cPR, another 2 cycles of chemotherapy will be performed, and CT and rectal
MRI evaluations will be performed again after treatment. Radical rectal cancer surgery
and LLND were performed 4-6 weeks after the last administration (unilateral or bilateral
LLND was determined based on the metastasis of LLN before treatment).
- RECIST evaluates patients with SD, and if MRI evaluates rectal cancer patients without
rectal fascia involvement (MRF -), they will undergo two cycles of triple drug
combination chemotherapy. After treatment, CT and rectal MRI evaluations will be
performed again. Rectal cancer radical surgery+LLND will be performed 4-6 weeks after
the last administration.
- If MRF+is unable to complete R0 resection or RECIST evaluation of PD patients, in order
to ensure the treatment effect of the patients, preoperative long-term synchronous
radiotherapy and chemotherapy should be performed. Preoperative concurrent
chemoradiotherapy regimen: Capecitabine (1650mg/m2/day, twice orally); Radiotherapy
(pelvic cavity 2 Gy/dose, GT50 Gy); Intensity modulated radiation therapy is used for
radiotherapy. CT and rectal MRI evaluations are performed again 8-12 weeks after
radiotherapy, followed by rectal cancer radical surgery and LLND. If distant metastasis
occurs during treatment, a second-line chemotherapy regimen can be chosen.
Researchers will compare another group (Capecitabine (1650mg/m2/day, oral administration
twice) was used for long-term concurrent chemoradiotherapy before operation in all patients;
Radiotherapy (pelvic cavity 2 Gy/dose, GT50 Gy). Intensity modulated radiation therapy is
used for radiotherapy. CT and rectal MRI evaluation are performed again 8-12 weeks after
radiotherapy, followed by rectal cancer radical surgery+LLND (unilateral or bilateral LLND is
determined based on the LLN metastasis before treatment)) to see if the experimental group is
superior to the control group in terms of 3-year disease free survival, local recurrence
rate, lateral lymph node positivity rate, and 5-year overall survival rate.