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

Conditions

Rectal Cancer

Keywords

rectal cancer；, neoadjuvant Chemotherapy

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.

Yu Shen, Xiaoling Gong, Meng Qiu, Wenjian Meng, Ziqiang Wang

Proceedings on CD-ROM - International Society for Magnetic Resonance in Medicine. Scientific Meeting and Exhibition/Proceedings of the International Society for Magnetic Resonance in Medicine, Scientific Meeting and Exhibition2024-11-26

10.58530/2024/1169

Early response to upfront neoadjuvant chemotherapy (CAPOX) alone in low- and intermediate-risk rectal cancer: a single-arm phase II trial

Xiangbing Deng, Qingbin Wu, Liang Bi, Yongyang Yu, Shuo Huang et al. (12 authors)

British journal of surgery2021-10-1624 citations

10.1093/bjs/znab388

Effect of neoadjuvant chemotherapy and early chemotherapeutic response evaluation for low/intermediated-risk mid-low stage II/III rectal cancer: A prospective, open-label, single-arm, phase II trial.

Xiangbing Deng, Liang Bi, Qingbin Wu, Du He, Hongfeng Gou et al. (10 authors)

Journal of Clinical Oncology2020-05-20

10.1200/jco.2020.38.15_suppl.e16133

Interventions

DRUGXELOX

Xelox chemotherapy,that oxaliplatin 130mg/m2 d1,capecitabine 1000mg/m2 twice daily d1-14,every 3 weeks

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

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.

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

No

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;

Design outcomes

Primary

Measure	Time frame	Description
tumor volume	At the end of Cycle 2 (each cycle is 3 weeks)	tumor volume measured by MRI
tumor area in endoscopy	At the end of Cycle 2 (each cycle is 3 weeks)	tumor area measured in endoscopy

Secondary

Measure	Time frame	Description
blood DNA test	At the end of Cycle 2 (each cycle is 3 weeks)	blood DNA test
tumor thickness in TRUS	At the end of Cycle 4 (each cycle is 3 weeks)	tumor thickness in TRUS

Countries

China

Outcome results

None listed