Treating Locally Advanced Rectal Cancer With TAS-102 Chemotherapy Plus Neoadjuvant Radiotherapy

NCT05965531 | Recruiting Phase 2 DMC

• 1 other identifier: 2023-FXY-087
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this Phase 2 trial is to evaluate a neoadjuvant treatment mode for locally advanced rectal cancer (LARC), consisting of radiotherapy and concurrent Trifluridine/Tipiracil (TAS-102). The main questions it aims to answer are: (i) whether TAS-102 is effective in treating LARC, when combined with radiotherapy; (ii) whether TAS-102 is safe in combination with radiotherapy. Participants will receive one cycle of TAS-102 chemotherapy and neoadjuvant radiotherapy based on intensity-modulated technique. Then the ones with a possibility of R0 resection will receive radical surgery followed by 6 cycles of adjuvant XELOX (capecitabine plus oxaliplatin) chemotherapy.

Conditions

Rectal Cancer

Keywords

rectal cancer; Trifluridine/Tipiracil; radiotherapy

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  The percentage of the patients complete R0 resection and attain a tumor regression grade of 1-4 (Mandard's 5-tier standard) in postsurgical pathologic examination

  One week after surgery

Secondary Outcomes (5)

• Pathological complete response rate

  One week after surgery

• The incidence of grade 3/4 toxicities

  Once a week during the period of neoadjuvant treatment

• The incidence of grade 3/4 complications

  The period from the date of radical surgery to the 90th day after surgery

• Disease-free survival

  When all the patients are followed-up for 1, 2 and 5 years

• Overall survival

  When all the patients are followed-up for 1, 2 and 5 years

Study Arms (1)

Neoadjuvant chemo-radiotherapy with TAS-102

EXPERIMENTAL

The patients in this group will all receive neoadjuvant treatment consisting of intensity-modulated radiotherapy and concurrent Trifluridine/Tipiracil (TAS-102). Then the ones evaluated to have a possibility of R0 resection will receive radical surgery, followed by 6 cycles of adjuvant XELOX (capecitabine plus oxaliplatin) chemotherapy.

Drug: Trifluridine/Tipiracil; Radiation: intensity-modulated radiotherapy

Interventions

Trifluridine/Tipiracil DRUG

TAS-102 is given in a dose of 35 mg/m2, twice daily on the 1st to 5th and 8th to 12th days of the period of neoadjuvant radiotherapy.

Also known as: TAS-102

Neoadjuvant chemo-radiotherapy with TAS-102

intensity-modulated radiotherapy RADIATION

intensity-modulated radiotherapy

Neoadjuvant chemo-radiotherapy with TAS-102

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically diagnosed rectal adenocarcinoma via biopsy
• Pretreatment clinical TNM stage as T3-4N0M0 or T1-4N1-2M0 (UICC TNM staging classification, version 8)
• Tumor with proficient DNA mismatch repair confirmed by immunohistochemical analysis
• Age between 18 and 75 years old
• Karnofsky performance score ≥ 70
• Distance from tumor lower margin to anal verge \< 12 cm

You may not qualify if:

• Inguinal lymph node metastasis
• Multiple primary colorectal cancer
• Complete obstruction or perforation
• Uncontrolled tuberculosis, AIDS or mental diseases
• Severe cardiac, renal, hepatic or hematopoietic dysfunctions unsuitable for chemotherapy or radiotherapy
• Prior history of other malignancies with 5 years, except cured cervical carcinoma in situ and skin basal cell carcinoma
• Prior history of rectal surgery, pelvic radiotherapy or chemotherapy
• Pregnant or lactating women
• Other situations for which the investigators consider a patient inappropriate to participate

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Cancer Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

trifluridine tipiracil drug combination; Radiotherapy, Intensity-Modulated

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)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Hui Chang, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui Chang, MD

CONTACT

+86-020-87343374; changhui@sysucc.org.cn

Qiao-xuan Wang, MD

CONTACT

+86-020-87343374; wangqx@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: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This phase 2 trial is an open-label, single-arm, non-comparative trial, in which all enrolled patients will receive neoadjuvant single-agent TAS-102 chemotherapy plus intensity-modulated radiotherapy, before surgery.

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: July 28, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

CN (1)