Triplet Combination or Doublet Regimen Versus Chemoradiation as Neoadjuvant Therapy for Locally Advanced Rectal Cancer

• Status: Not yet recruiting
• Trial end date: 2029-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Preoperative radiation with single agent chemotherapy as sensitizer is the standard care of locally advanced rectal cancer.

Local irradiation significantly increases surgical complications and impairs quality of life.

Combination chemotherapy alone seems promising and provides similar benefit to chemoradiation as neoadjuvant therapy.

Early administration of systemic therapy is also proved beneficial for long-term survival.

The purpose of this study is to compare the efficacy of chemotherapy alone with short-term modified FOLFOXIRI or long-term mFOLFOX with standard chemoradiation as neoadjuvant therapy for locally advanced rectal cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Criteria

Inclusion Criteria:

• 1）Age: 18 to 75 years old;

• 2）Histological diagnosis of rectal adenocarcinoma;

• 3）Distance form anal margin ≤ 12cm: cT3-4 or cN+ and cM0 by pelvic MR and chest + abdominal CT, estimated possible for R0 resection;

• 4）There is no signs of intestinal obstruction, or obstruction of intestinal after treating with proximal colostomy has been relieved;

• 5）Patients did not previously receive rectal surgery, chemotherapy or radiation therapy , biological treatment , except for endocrine therapy;

• 6）ECOG Performance Status :0-1

• 7）Life expectancy: more than 3 years;

• 8）sufficient bone marrow, liver and kidney function.

Exclusion Criteria:

• 1）Arrhythmia requires treatment with antiarrhythmia (except for beta-blockers or digoxin), symptomatic coronary artery disease, myocardial ischemia (myocardial infarction within the last 6 months) or congestive heart failure exceeding NYHA class II;

• 2）Severe hypertension with poor control;

• 3）History of HIV infection or active phase of chronic hepatitis B or C infection with high copy viral DNA;

• 4）Other active serious infections according to NCI-CTC version 4.0;

• 5）There is preoperative evidence for distant metastasis outside pelvis;

• 6）Cachexia and organ function decompensation

• 7）History of pelvic or abdominal radiotherapy;

• 8）Multiple primary cancer;

• 9）Patients with epilepcy requiring treatment ( steroids or antiepileptic treatment);

• 10）History of other malignant tumors within 5 years, except for cured cervical carcinoma in situ or skin basal cell carcinoma;

• 11）Drug abuse and medical, psychological or social conditions interfering patient participation in research or the evaluation of research results;

• 12）Any allergy to clinical research drugs or any drugs associated with this study;

• 13）Any unstable condition or condition that may endanger safety and compliance of patients;

• 14）Pregnancy or the lactating female without adequate contraception.