A Study Comparing Adjuvant Chemotherapy Versus Observation for Patients With Rectal Adenocarcinoma After Neoadjuvant Chemo-Radiotherapy Treatment.
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|ClinicalTrials.gov Identifier: NCT01941979|
Recruitment Status : Unknown
Verified October 2014 by Instituto do Cancer do Estado de São Paulo.
Recruitment status was: Recruiting
First Posted : September 13, 2013
Last Update Posted : October 30, 2014
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Rectal Cancer||Drug: 5-FU, Capecitabine, Oxaliplatin, Leucovorin.||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||309 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III, Randomized Study of Adjuvant Chemotherapy for Patients With Rectal Adenocarcinoma Who Achieved Suboptimal Response After Neoadjuvant Chemo-radiotherapy.|
|Study Start Date :||September 2011|
|Estimated Primary Completion Date :||September 2015|
|Estimated Study Completion Date :||September 2016|
Experimental: Adjuvant therapy
5-FU, Leucovorin and Oxaliplatine (FLOX) OR Capecitabine and Oxaliplatin (CAPOX)
NOTE: If the patient was randomized for the arm experimental, the investigator can choose between intravenous (IV) treatment or oral treatment (PO). Both are considered equal by the principal investigator.
Drug: 5-FU, Capecitabine, Oxaliplatin, Leucovorin.
|No Intervention: Observation|
- Disease free survival [ Time Frame: Thorax, abdome, and pelvis tomography Every 6 month up to 3 years and anualy up to 5 years. ]
- Overall survival [ Time Frame: 36 month ]
- Incidence of Adverse Event [ Time Frame: 36 month ]To evaluate the toxicity of treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01941979
|Contact: Rachel S.P. Riechelmann, MD||55 11 email@example.com|
|Sao Paulo, SP, Brazil, 01246000|
|Contact: Rachel SP Riechelmann, MD 55 11 38932000 firstname.lastname@example.org|
|Principal Investigator: Rachel SP Riechemann, MD|