Rectum Cancer
Conditions
Keywords
Neoadjuvant, mFOLFIRINOX, TNT, Watch and wait approach, Complete clinical response, Sphincter sparing
Brief summary
A phase II clinical trial compared standard TNT (mFolfox6 and CRT) with preoperative chemoradiotherapy (CRT) with neoadjuvant chemotherapy (CT) containing mFolfirinox in patients with locally advanced rectal cancer.
Detailed description
This open-label randomized, two-arm phase II trial compared the standard total neoadjuvant approach (TNT) with neoadjuvant CT with mFolfirinox and preoperative CRT in patients with locally advanced rectal cancer.
Interventions
DRUGmFOLFIRINOX
Neoadjuvant chemotherapy
DRUGmFolfox6
Neoadjuvant chemotherapy
Sponsors
Menoufia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Histologically proven rectal adenocarcinoma. 2. Stages cT3 with risk of local recurrence, cT4, or N positive, M0 and for which a multidisciplinary meeting recommend TNT. 3. Resectable tumor, or considered as potentially resectable after CRT. 4. No distant metastases. 5. Patient eligible for surgery 6. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status 0/1. 7. No heart failure or coronary heart disease symptoms (even controlled). 8. No peripheral neuropathy \> grade 1. 9. No prior radiotherapy of the pelvis for any reason and no previous CT 10. No major comorbidity that may preclude the delivery of treatment 11. Adequate contraception in fertile patients. 12. Adequate hematologic function. 13 Adequate hepatic function. 14\. Signed written informed consent.
Exclusion criteria
1. Metastatic disease 2. Unresectable rectal cancer, including prostatic involvement or extension to pelvic floor muscles Contraindication to 5-FU, or to oxaliplatin or to irinotecan, including Gilbert disease or genotype UGT1A1 3. Medical history of chronic diarrhea or inflammatory disease of the colon or rectum 4. Medical history of angina pectoris or myocardial infarction 5. Other concomitant cancer. 6. Pregnant or breast-feeding woman. 7. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete clinical response rate | 6 months | an absence of clinical, endoscopic or imaging evidence of a rectal tumor during the restaging of a patient with locally advanced rectal cancer after neoadjuvant therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| disease-free survival | 3 years | Disease-free survival (DFS) will be defined as the time from randomization to recurrence of tumor or death |
| Toxicity of chemotherapy | 6 months | Common Terminology Criteria for Adverse Events (CTCAE) v 5 |
| complete pathological response rectal cancer | 6 months | the absence of malignant cells on the specimen of rectal resection in patients who were previously treated with neoadjuvant CRT. |
| Overall survival | 5 years | Overall survival will be defined as the time from randomisation to the time of occurrence of the first death regardless to its cause. Patients alive at the time of analysis will be censored at the date of the last follow up. |
Countries
Egypt
Contacts
Primary ContactE Morkos
Outcome results
None listed