NCT03975049Not yet recruitingPhase 3
Triplet Combination or Doublet Regimen Versus Chemoradiation as Neoadjuvant Therapy for Locally Advanced Rectal Cancer
A Prospectively Randomized Phase III Trial Comparing Short-term mFOLFOXIRI, Long-term mFOLFOX6 and Traditional Chemoradiation as Preoperative Neoadjuvant Therapy for Locally Advanced Rectal Cancer
Source: ClinicalTrials.gov · Last updated 5 Jun 2019 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 933 (estimated)
- First submitted
- 22 May 2019
- Start date
- Aug 2019
- Primary completion date
- Jul 2024
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Diseases
- Colorectal cancer
- NCT number
- NCT03975049
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 933
- From Aug 2019 to the primary completion date, Jul 2024
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
- 9）Patients with epilepcy requiring treatment ( steroids or antiepileptic treatment);
Other illness
- 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;
- 7）History of pelvic or abdominal radiotherapy;
- 8）Multiple primary cancer;
- 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;
Other
- 5）There is preoperative evidence for distant metastasis outside pelvis;
- 6）Cachexia and organ function decompensation
- 14）Pregnancy or the lactating female without adequate contraception.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.