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

NCT03975049 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: SAHMO201
• Study Type: interventional
• Target: 933
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Rectal Cancer; Chemotherapy Effect

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  The interval from randomization to local recurrence, distant metastasis, death or the last follow-up.

  3 years

Secondary Outcomes (4)

• Recurrence-free survival

  3 years

• Metastasis-free survival

  3 years

• Surgical complication

  3 years

• Treatment related quality of life

  up to 3 years

Other Outcomes (1)

• Tumor regression grade after neoadjuvant therapy

  3 months

Study Arms (3)

5-Fu + RT

ACTIVE COMPARATOR

5Fu + RT for five weeks --- 6-8 weeks of interval --- TME --- mFOLFOX \* 6-8

Radiation: Chemoradiation

mFOLFOXIRI

EXPERIMENTAL

mFOLFOXIRI \* 4 --- TME --- mFOLFOXIRI \* 4

Drug: FOLFOXIRI Protocol

mFOLFOX

EXPERIMENTAL

mFOLFOX \* 9 --- TME --- mFOLFOX \* 3

Drug: Folfox Protocol

Interventions

Chemoradiation RADIATION

Fluorouracil 225 mg/m2/day continuous intravenous infusion on weekdays for five weeks; local irradiation 2GY/day on weekdays, totally 50GY.

5-Fu + RT

FOLFOXIRI Protocol DRUG

Oxaliplatin 85 mg/m2 on day 1; irinotecan 150 mg/m2 on day 1; leucovorin 400 mg/m2 on day 1; fluorouracil 2400 mg/m2 civ over 46h; treatment will be repeated every 14 days; prophylactic G-CSF support is recommended.

mFOLFOXIRI

Folfox Protocol DRUG

Oxaliplatin 85 mg/m2 on day 1; leucovorin 400 mg/m2 on day 1; fluorouracil 400 mg/m2 bolus and 2400 mg/m2 civ over 46h; treatment will be repeated every 14 days.

mFOLFOX

Eligibility Criteria

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

You may qualify if:

• ）Age: 18 to 75 years old;
• ）Histological diagnosis of rectal adenocarcinoma;
• ）Distance form anal margin ≤ 12cm: cT3-4 or cN+ and cM0 by pelvic MR and chest + abdominal CT, estimated possible for R0 resection;
• ）There is no signs of intestinal obstruction, or obstruction of intestinal after treating with proximal colostomy has been relieved;
• ）Patients did not previously receive rectal surgery, chemotherapy or radiation therapy , biological treatment , except for endocrine therapy;
• ）ECOG Performance Status :0-1
• ）Life expectancy: more than 3 years;
• ）sufficient bone marrow, liver and kidney function.

You may not qualify if:

• ）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;
• ）Severe hypertension with poor control;
• ）History of HIV infection or active phase of chronic hepatitis B or C infection with high copy viral DNA;
• ）Other active serious infections according to NCI-CTC version 4.0;
• ）There is preoperative evidence for distant metastasis outside pelvis;
• ）Cachexia and organ function decompensation
• ）History of pelvic or abdominal radiotherapy;
• ）Multiple primary cancer;
• ）Patients with epilepcy requiring treatment ( steroids or antiepileptic treatment);
• ）History of other malignant tumors within 5 years, except for cured cervical carcinoma in situ or skin basal cell carcinoma;
• ）Drug abuse and medical, psychological or social conditions interfering patient participation in research or the evaluation of research results;
• ）Any allergy to clinical research drugs or any drugs associated with this study;
• ）Any unstable condition or condition that may endanger safety and compliance of patients;
• ）Pregnancy or the lactating female without adequate contraception.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Chemoradiotherapy; FOLFOXIRI protocol; Folfox protocol

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)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Officials

• Ping Lan, MD

  Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ping Lan, MD

CONTACT

86-20-38285497; lanping@mail.sysu.edu.cn

Jian Xiao, MD

CONTACT

86-20-38285497; xiaoj26@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: June 5, 2019
• Study Start: August 1, 2019
• Primary Completion: July 1, 2024
• Study Completion (Estimated): July 1, 2029
• Last Updated: June 5, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share