Modified Sandwich Therapeutic Regimen for Locally Advanced Rectal Cancer

NCT05228431 | Recruiting Phase 2 DMC

• 1 other identifier: 2021-FXY-494-Department of CRC
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Rectal Cancer

Keywords

Rectal cancer; neoadjuvant chemoradiotherapy; optimization

Outcome Measures

Primary Outcomes (1)

• Rate of pCR

  rate of pathological complete remission

  One week after surgery

Secondary Outcomes (2)

• DFS

  3 years

• OS

  5 years

Study Arms (1)

Sandwich Regimen

EXPERIMENTAL

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

Drug: XELOX; Drug: Capecitabine monotherapy; Radiation: Radiation

Interventions

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.

Sandwich Regimen

Capecitabine monotherapy DRUG

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

Sandwich Regimen

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.

Sandwich Regimen

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Multiple primary tumor
• Cachexy

Sponsors & Collaborators

• Zhen-Hai Lu: lead

Study Sites (1)

Zhenhai Lu

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

XELOX; Radiation

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Central Study Contacts

Zhenhai Lu, Prof

CONTACT

+862087343584; luzhh@sysucc.org.cn

Jianhong Peng, M.D

CONTACT

+862087343584; pengjh@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Pofessor

Study Record Dates

• First Submitted: January 22, 2022
• First Posted: February 8, 2022
• Study Start: March 2, 2022
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 22, 2024

Record last verified: 2024-04

Locations

CN (1)