Rectal Cancer Clinical Trial
Official title:
A Phase III, Randomized Study of Adjuvant Chemotherapy for Patients With Rectal Adenocarcinoma Who Achieved Suboptimal Response After Neoadjuvant Chemo-radiotherapy.
Surgery is the most indicated curative treatment for rectal cancer when disease is diagnosed
early, however local recurrence risk increases when the disease is diagnosed at advanced
stage.T1-2 tumors have a recurrence rate lower than 10%, while T3N0 tumors have 15% - 35%
and positive lymph nodes T3-4 45% to 67% of recurrence rate within 5 years. These data
indicate that patient who have a high risk of tumor recurrence should receive an adjuvant
therapy treatment.
It is possible that adjuvant chemotherapy has a positive impact on survival of patients
already treated with neoadjuvant combination therapy. However it is necessary to identify
those patients that might have this benefit.
An exploratory analysis of the European Organization for Research and Treatment of Cancer
(EORTC) 22921 study showed that the addition of adjuvant chemotherapy has benefited only the
group of patients who had a reduction of tumor stage to ypT0-2. In the group who had no
reduction (ypT3-4), there was no benefit. Retrospective analyzes suggest that the response
to neoadjuvant chemoradiotherapy is a predictor of prognosis and even benefit to adjuvant
chemotherapy. However the benefit of adjuvant chemotherapy for patients with rectal cancer
remains controversial. Therefore, a randomized trial is needed to answer this question.
Based on these data the investigators proposed a phase III study, randomized, unblinded,
adjuvant chemotherapy based on Fluorouracil(5-FU) and Oxaliplatin versus observation in
patients with rectal adenocarcinoma T3-4, N0-1, M0 previously treated with neoadjuvant
chemoradiotherapy and who did not presented complete response. The investigator believes
that this subgroup of patients, who have not achieved complete response, will be benefit
from adjuvant therapy.
Study objective:
The main objective of this study is verify if adjuvant chemotherapy with 5-FU and
oxaliplatin, for 4 months, increases recurrence-free survival versus the observation.
Secondary objectives include the evaluation of toxicity, overall survival and assessment of
biomarkers (study protocol separately).
The study's primary endpoint is disease-free survival (DFS) to be defined as time from
randomization to radiological detection of distant disease and / or locoregional recurrence.
Isolate carcinoembryonic antigen (CEA) increase will not be consider as recurrence until a
new measurable lesion be found.
NOTE: The TNM system is based on the size and/or extent (reach) of the primary tumor (T),
the amount of spread to nearby lymph nodes (N), and the presence of metastasis (M) or
secondary tumors formed by the spread of cancer cells to other parts of the body.
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06380101 -
Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC)
|
N/A | |
Active, not recruiting |
NCT05551052 -
CRC Detection Reliable Assessment With Blood
|
||
Recruiting |
NCT04323722 -
Impact of Bladder Depletion on Mesorectal Movements During Radiotherapy in Rectal Cancer
|
N/A | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04088955 -
A Digimed Oncology PharmacoTherapy Registry
|
||
Active, not recruiting |
NCT01347697 -
Collagen Implant (Biological Mesh) Versus GM Flap for Reconstruction of Pelvic Floor After ELAPE in Rectal Cancer
|
N/A | |
Recruiting |
NCT04495088 -
Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer
|
Phase 3 | |
Withdrawn |
NCT03007771 -
Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia
|
Phase 1 | |
Terminated |
NCT01347645 -
Irinotecan Plus E7820 Versus FOLFIRI in Second-Line Therapy in Patients With Locally Advanced or Metastatic Colon or Rectal Cancer
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT03520088 -
PROSPECTIVE CONTROLLED AND RANDOMIZED STUDY OF THE GENITOURINARY FUNCTION AFTER RECTAL CANCER SURGERY IN RELATION TO THE DISSECTION OF THE INFERIOR MESENTERIC VESSELS
|
N/A | |
Recruiting |
NCT05556473 -
F-Tryptophan PET/CT in Human Cancers
|
Phase 1 | |
Recruiting |
NCT04749381 -
The Role of TCM on ERAS of Rectal Cancer Patients
|
Phase 2 | |
Enrolling by invitation |
NCT05028192 -
Mitochondria Preservation by Exercise Training: a Targeted Therapy for Cancer and Chemotherapy-induced Cachexia
|
||
Recruiting |
NCT03283540 -
Transanal Total Mesorectal Excision for Rectal Cancer on Anal Physiology + Fecal Incontinence
|
||
Completed |
NCT04534309 -
Behavioral Weight Loss Program for Cancer Survivors in Maryland
|
N/A | |
Recruiting |
NCT05914766 -
An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer
|
N/A | |
Recruiting |
NCT04852653 -
A Prospective Feasibility Study Evaluating Extracellular Vesicles Obtained by Liquid Biopsy for Neoadjuvant Treatment Response Assessment in Rectal Cancer
|
||
Recruiting |
NCT03190941 -
Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients
|
Phase 1/Phase 2 | |
Completed |
NCT02810652 -
Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection
|
N/A | |
Terminated |
NCT02933944 -
Exploratory Study of TG02-treatment as Monotherapy or in Combination With Pembrolizumab to Assess Safety and Immune Activation in Patients With Locally Advanced Primary and Recurrent Oncogenic RAS Exon 2 Mutant Colorectal Cancer
|
Phase 1 |