Randomized Controlled Study on Optimize Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer

Conditions

Advanced Rectal Cancer

Keywords

Rectal cancer, neoadjuvant chemoradiotherapy, optimization

Brief summary

Although neoadjuvant chemoradiotherapy has significantly reduced the risk of local recurrence in locally advanced rectal cancer, systemic failure remains a predominant issue probably due to the insufficient control of systemic micro-metastasis in the neoadjuvant treatment. Induction chemotherapy is one of the most studied strategies. However, the efficacy of induction chemotherapy prior to neoadjuvant chemotherapy remains controversial. In our previous study, induction chemotherapy, gap chemotherapy combined with neoadjuvant chemoradiotherapy can improve response rate of rectal cancer patients, but the results have not been confirmed in clinical trial. Whether this new kind of treatment can optimize neoadjuvant therapy for locally advanced rectal cancer or not is still a big problem in clinical practice. This study will focus on how to optimize neoadjuvant chemotherapy.

Rongxin Zhang, Fulong Wang, Xinhua Jiang, Hao Wang, Weili Zhang et al. (19 authors)

MedComm2025-07-23

10.1002/mco2.70222

SONCAR study: A prospective randomized controlled study on optimized neoadjuvant chemotherapy-oxaliplatin plus CRT in patients with locally advanced rectal cancer.

Rongxin Zhang, Zhifan Zeng, Yuanhong Gao, Xiaojun Wu, Gong Chen et al. (13 authors)

Journal of Clinical Oncology2022-01-192 citations

10.1200/jco.2022.40.4_suppl.117

Predictive value of circulating tumor DNA in locally advanced rectal cancer patients receiving neoadjuvant radiochemotherapy.

Min Li, Weiwei Xiao, Grace Zhao, Zhiwei Guo, Xuexi Yang et al. (9 authors)

Journal of Clinical Oncology2017-05-204 citations

10.1200/jco.2017.35.15_suppl.e15125

The safety of four cycles of CAPEOX combined with radiotherapy vs. capecitabine combine with radiotherapy for locally advanced rectal cancer: Mid-term analysis of NCT02031939.

Rongxin Zhang, Zhenhai Lu, Fulong Wang, Desen Wan, Yuanhong Gao et al. (10 authors)

Journal of Clinical Oncology2016-05-20

10.1200/jco.2016.34.15_suppl.e14040

Interventions

DRUGInduction chemotherapy, Chemoradiotherapy and gap chemotherapy (Capecitabine combine with oxaliplatin)

All rectal cancer patients in this group will receive induction, gap chemotherapy (capecitabine combined with oxaliplatin) alone with chemoradiotherapy (capecitabine combine with oxaliplatin) before surgery.

RADIATIONstandard chemoradiotherapy

All rectal patients in this group will receive standard radiotherapy and surgical resection.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

No

Inclusion criteria

* Pathological confirmed rectal cancer * Clinical stage T3-4 or T any N1 * No metastasis * Distance of tumor is no more than 10cm from anal verge * No previous radiotherapy * Age ranged from 18 to 70 * Eastern Cooperative Oncology Group score system 0-1

Exclusion criteria

* Clinical stage T1-2 N0 * Distance metastasis * Multiple primary tumor * Cachexy

Design outcomes

Primary

Measure	Time frame
overall survival	5 years

Secondary

Measure	Time frame
disease free survival	3 years
Disease free survival	5 years
Respond rate	One week after surgery

Countries

China

Outcome results

None listed