Rectal CancerPhase 3NCT01941979
A Study Comparing Adjuvant Chemotherapy Versus Observation for Patients With Rectal Adenocarcinoma After Neoadjuvant Chemo-Radiotherapy Treatment.
A Phase 3 study testing 5-FU, Capecitabine, Oxaliplatin, Leucovorin. in people with Rectal Cancer, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- 5-FU, Capecitabine, Oxaliplatin, Leucovorin.
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 309 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2011to Sep 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of adenocarcinoma rectal stages T3 - 4, N0-1 and M0 - according to TNM staging system (primary tumor, regional nodes, metastasis), previously treated with neoadjuvant chemo-radiotherapy according to institutional routine.
- Tumor with clinical end radiological incomplete response after neoadjuvant therapy, according to institutional routine, and completely resection by mesorectal excision with clear margins technique.
- No more than 8 weeks after the surgery.
- Normal result of CEA in compared to the pre randomization results (28 days of window)
- Age ≥ 18 years and ≤ 75 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Show all 15Show fewer
- Adequate organ function during screening (28 days of window)
- , defined as:
- Serum aspartate aminotransferase (AST) and amino alanine transferase (ALT) ≤ 2.5 × Upper Limit of Normal(ULN)
- Serum total bilirubin ≤ 2.0 × ULN
- Absolute neutrophil count ≥ 1500 /mm3
- Platelet count ≥ 100000 /mm3
- Hemoglobin ≥ 8.0 g/dL
- Serum creatinine ≥ 1.5 × ULN
- Signed written informed consent
Who cannot join
- Patients who presented unacceptable toxicity or intolerance to neoadjuvant combination therapy.
- Patients with surgical complications that prevent them from receiving adjuvant therapy for up to 8 weeks after surgery;
- Compromised surgical margins.
- Confirmation or strong suspicion of Lynch syndrome.
- History of serious illness or psychiatric clinic.
- Patients who participate in other protocols with experimental drugs.
- For female patients, current pregnancy and/or lactation.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
ICESP
São Paulo, São Paulo, 01246000
Rachel SP Riechelmann, MD, 55 11 38932000, pesquisa.clinica@icesp.org.br
Rachel SP Riechemann, MD
About this study
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.
Read more
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.
- Conditions
- Rectal Cancer
- Being tested
- 5-FU, Capecitabine, Oxaliplatin, Leucovorin.
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-FU, Capecitabine, Oxaliplatin, Leucovorin.Drug
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant therapy | Experimental | 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. Receives: Drug: 5-FU, Capecitabine, Oxaliplatin, Leucovorin. |
| Observation | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Measured: Thorax, abdome, and pelvis tomography Every 6 month up to 3 years and anualy up to 5 years.
Secondary outcomes (1)
Overall survival
Measured: 36 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startSep 2011
- Primary completionSep 2015 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 309 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01941979
- Sponsor's protocol ID
- NP-113/2011
- Status last verified
- Oct 2014
- First submitted
- 4 Sep 2013
- Last updated
- 30 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized Study of Adjuvant Chemotherapy for Patients With Rectal Adenocarcinoma Who Achieved Suboptimal Response After Neoadjuvant Chemo-radiotherapy.
- ClinicalTrials.gov ID
- NCT01941979
- Acronym / sponsor ID
- NP-113/2011
- Conditions
- Rectal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 309 participants (estimated)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 13 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjuvant therapy | Experimental | Drug: 5-FU, Capecitabine, Oxaliplatin, Leucovorin.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. |
| Observation | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Diagnosis of adenocarcinoma rectal stages T3 - 4, N0-1 and M0 - according to TNM staging system (primary tumor, regional nodes, metastasis), previously treated with neoadjuvant chemo-radiotherapy according to institutional routine.
- Tumor with clinical end radiological incomplete response after neoadjuvant therapy, according to institutional routine, and completely resection by mesorectal excision with clear margins technique.
- No more than 8 weeks after the surgery.
- Normal result of CEA in compared to the pre randomization results (28 days of window)
- Age ≥ 18 years and ≤ 75 years.
Key exclusion criteria (7 listed)
- Patients who presented unacceptable toxicity or intolerance to neoadjuvant combination therapy.
- Patients with surgical complications that prevent them from receiving adjuvant therapy for up to 8 weeks after surgery;
- Compromised surgical margins.
- Confirmation or strong suspicion of Lynch syndrome.
- History of serious illness or psychiatric clinic.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5-FU, Capecitabine, Oxaliplatin, Leucovorin. | Drug | Adjuvant therapy |
Primary outcome
Disease free survival
Time frame: Thorax, abdome, and pelvis tomography Every 6 month up to 3 years and anualy up to 5 years.
1 secondary outcome
Overall survival
Time frame: 36 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2014.
- Related InfoLink provided by the sponsor.
Related trials for Rectal Cancer
RecruitingPhase 1/2
A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Colorectal Cancer
RecruitingPhase 1
Phase 1 Study Of SAR445877 In Combination With FOLFOX6 And Bevacizumab As First-Line Treatment For Microsatellite Stable Metastatic Colorectal Cancer
Phase 1, SAR445877
Recruiting
Addressing Disparities in Colorectal Cancer Screening in Black and Underserved Phoenix Communities
Colorectal Carcinoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruiting
Smartphone-enabled Hybrid Identification of Early CoLorectal Disease Using Blood-Based Cancer Testing Across TeXas
Colorectal Cancer (CRC) Screening
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 5-FU, Capecitabine, Oxaliplatin, Leucovorin. in people with Rectal Cancer, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel S.P. Riechelmann, MD (55 11 38932000, pesquisa.clinica@icesp.org.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (time frame: Thorax, abdome, and pelvis tomography Every 6 month up to 3 years and anualy up to 5 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2014.