Early Evaluation of Chemosensitivity for Low/Intermediated-risk Mid-low Stage II/III Rectal Cancer

Sichuan University

Status and phase: Completed; Phase 2

Conditions: Rectal Cancer

Treatments: Drug: XELOX

Study type: Interventional

Funder types: Other

Identifiers

NCT03666442

RC-CT-2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

61 participants in 1 patient group

chemotherapy group

Experimental group

Description:

patients receive 4 cycles of Xelox

Treatment:

Drug: XELOX