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Modified Sandwich Therapeutic Regimen for Locally Advanced Rectal Cancer

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05228431
Enrollment
121
Registered
2022-02-08
Start date
2022-03-02
Completion date
2028-05-01
Last updated
2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Rectal Cancer

Keywords

Rectal cancer, neoadjuvant chemoradiotherapy, optimization

Brief summary

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.

Interventions

DRUGXELOX

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.

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

RADIATIONRadiation

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.

Sponsors

Zhen-Hai Lu
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of pCROne week after surgeryrate of pathological complete remission

Secondary

MeasureTime frameDescription
DFS3 yearsDisease free survival
OS5 yearsoverall survival

Countries

China

Contacts

Primary ContactZhenhai Lu, Prof
luzhh@sysucc.org.cn+862087343584
Backup ContactJianhong Peng, M.D
pengjh@sysucc.org.cn+862087343584

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026