Clinical trial NCT03666442: Early Evaluation of Chemosensitivity for Low/Intermediated-risk Mid-low Stage II/III Rectal Cancer
Official title: Early Evaluation of Chemosensitivity for Low-risk Stage II/III Rectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rectal Cancer
Keywords: rectal cancer；
neoadjuvant Chemotherapy
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2018-09-11
Enrollment: 61
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: a group of patients receive 4 cycle of Xelox chemotherapy, MRI,TRUS, DE,endoscopy, blood DNA test,before, between and after chemotherapy was compared to detect the effect of chemotherapy in 2 cycles.
Primary purpose: TREATMENT

Brief summary: Chemosensitivity of rectal cancer is not discussed clearly. With previous study, the investigators design this phase II trial to explore the effect of 2 cycles Xelox chemotherapy,so as to explore the early detection of sensitivity of tumor. With inclusion of early,intermediate,and bad stage II/III rectal cancer patients, four cycle of Xelox chemotherapy was given. After the second cycle, MRI,TRUS,DE,endoscopy,and blood DNA test was down to compare with these characteristics of four cycles.so that to detect the data about the chemosensitivity of tumor in the early stage.

Detailed description: Chemosensitivity of rectal cancer is not discussed clearly. With previous study, the investigators design this phase II trial to explore the effect of 2 cycles Xelox chemotherapy,so as to explore the early detection of sensitivity of tumor. With inclusion of early,intermediate,and bad stage II/III rectal cancer patients, four cycle of Xelox chemotherapy was given. After the second cycle, MRI,TRUS,DE,endoscopy,and blood DNA test was down to compare with these characteristics of four cycles.so that to detect the data about the chemosensitivity of tumor in the early stage.In future, a phase III trial that explore the effect of radiation or surgery in these chemoresistant patients.

Eligibility criteria: Inclusion Criteria:

1. .endoscopy and biopsy verified rectal cancer within 12cm from anal verge;
2. .primary MRI, TRUS, abdomino-chest CT diagnosed early or intermediate or bad Stage II/III rectal cancer;
3. .age from 20-75;
4. .with informed consent;

Exclusion Criteria:

1. .refuse the further treatment after recruiting;
2. .diagnosis of peritoneal metastasis in the surgery;

Primary outcomes:
measure: tumor volume
timeFrame: At the end of Cycle 2 (each cycle is 3 weeks)
measure: tumor area in endoscopy
timeFrame: At the end of Cycle 2 (each cycle is 3 weeks)
measure: tumor volume
timeFrame: At the end of Cycle 4 (each cycle is 3 weeks)
measure: tumor area in endoscopy
timeFrame: At the end of Cycle 4 (each cycle is 3 weeks)
Secondary outcomes:
measure: blood DNA test
timeFrame: At the end of Cycle 2 (each cycle is 3 weeks)
measure: blood DNA test
timeFrame: At the end of Cycle 4 (each cycle is 3 weeks)
measure: tumor thickness in TRUS
timeFrame: At the end of Cycle 4 (each cycle is 3 weeks)
measure: tumor thickness in TRUS
timeFrame: At the end of Cycle 2 (each cycle is 3 weeks)
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Guoxue Road 37#,West China Hospital
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Ziqiang Wang, MD
role: STUDY_CHAIR
References:
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