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NCT Number: NCT05228431

Modified Sandwich Therapeutic Regimen for Locally Advanced Rectal Cancer

In the treatment of locally advanced rectal cancer, the short-term and long-term efficacy of the traditional sandwich regimen has not reached satisfactory efficacy. For this reason, the concept of reducing the dose of postoperative chemotherapy or directly moving forward the full amount of postoperative chemotherapy was proposed, which is called total neoadjuvant therapy (TNT). However, TNT also includes the high toxicity of oxaliplatin in the whole process and the long time interval between the end of radiotherapy and the operation, which leads to fibrosis of the surrounding tissue, which increases the difficulty of surgical resection and makes it difficult to ensure good surgical specimen quality. In addition to this, there are issues that may increase the risk of potential disease progression in patients with poor treatment withdrawal. Therefore, appropriately reducing the intensity of chemotherapy and controlling the total duration of preoperative neoadjuvant therapy during radiotherapy is expected to alleviate the side effects of neoadjuvant therapy. Here, the investigators synthesized the characteristics of TNT and sandwich regimens and proposed a XELOX regimen and capecitabine alternate administration combined with preoperative intensity modulated radiation therapy.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Zhenhai Lu

Guangzhou, Guangdong, China

Location status: Recruiting

Location contact

Fulong Wang, M.D

SUB_INVESTIGATOR

Jiali Chen, M.D

SUB_INVESTIGATOR

Jianhong Peng, Doctor

CONTACT

[email protected]

+86 20 87343584

Jianhong Peng, M.D

SUB_INVESTIGATOR

Junzhong Lin, M.D

SUB_INVESTIGATOR

Qingjian Ou, M.D

SUB_INVESTIGATOR

Rongxin Zhang, M.D

SUB_INVESTIGATOR

Weili Zhang, M.D

SUB_INVESTIGATOR

Weiwei Xiao, M.D

SUB_INVESTIGATOR

Xiaojun Wu, M.D

SUB_INVESTIGATOR

Yuan Li, M.D

SUB_INVESTIGATOR

Yujing Fang, Ph.D

SUB_INVESTIGATOR

Zhenhai Lu, Prof

CONTACT

[email protected]

+86 20 87343584

Zhifan Zeng, M.D

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Pathological confirmed rectal adenocarcinoma.

Clinical stage T3-4 or T any N1.With or without MRF positivity, with or without EMVI positivity, R0 resection is estimated.

No metastasis

No signs of intestinal obstruction; or intestinal obstruction has been relieved after proximal colostomy surgery.

Age ranged from 18 to 75

No previous radiotherapy,surgery and chemotherapy.

Exclusion criteria

Multiple primary tumor

Cachexy

Treatment and study plan

XELOX

Drug

Starting from the first day of radiotherapy (set as day 0), the patient received a total of 4 courses of XELOX chemotherapy on days -42, -21, 42, and 63, including oxaliplatin 130 mg/m2, intravenous administration, d1, repeat every 3 weeks; and capecitabine 1000mg/m2, twice daily, d1-d14, repeat every 3 weeks.

Capecitabine monotherapy

Drug

During radiotherapy (Monday to Friday), capecitabine was administered at 1650 mg/m2/d, twice a day.

Radiation

Radiation

The TV is expanded by 6-7mm to form PTV1, and the CTV is expanded by 6-7mm to form PTV2. The dose of PTV1 was 50Gy/25 times/35 days, and the dose of PTV2 was 45Gy/25 times/35 days, 5 times/week for a total of 5 weeks.

Primary outcomes

  1. Rate of pCR

    Time frame: One week after surgery

    rate of pathological complete remission

Secondary outcomes

  1. DFS

    Time frame: 3 years

    Disease free survival

  2. OS

    Time frame: 5 years

    overall survival

Study contacts

Contact information is provided by the study sponsor or research team.

Jianhong Peng, M.D

CONTACT

[email protected]

+862087343584

Zhenhai Lu, Prof

CONTACT

[email protected]

+862087343584

Sponsors and collaborators

Lead sponsor

Zhen-Hai Lu

Other

Registry information

Official study title

Single Arm and Phase II Clinical Trial of a Sandwich Regimen as XELOX Regimen and Capecitabine Alternate Administration Combined With Preoperative Intensity Modulated Radiation Therapy for pMMR Locally Advanced Rectal Cancer

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Feb 8, 2022
Registry last updated
Apr 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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