Rectal CancerNCT02052921
Observation Versus Surgical Resection in Patients With Rectal Cancer Who Achieved Complete Clinical Response After Neoadjuvant Chemoradiotherapy
A study testing Rectal resection and Observation in people with Rectal Cancer, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial summary
With the possibility of pathological complete response in surgical specimens, some authors have proposed non-operative management of the patient group, when re-staged after neoadjuvant treatment, have complete clinical response. 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?
- Rectal resection and Observation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2011to 23 Apr 2020
- Phase
- Interventional
- 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
- Histological diagnosis of rectal adenocarcinoma
- tumors located within 10 cm from the anal verge by rigid proctoscopy measurement
- Complete clinical response after neoadjuvant treatment with chemoradiotherapy for rectal tumors clinical and radiologically staged as T3-4 N0 M0 or T (any) N + M0
- Absence of colorectal synchronous tumors
- Age between 18 and 75 years
- ECOG performance scale ≤ 2,
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- last dose of chemotherapy / radiation therapy in up to 12 weeks
- Good organic function
- Absence of serious comorbidities defined by the doctor to prevent surgical resection of the rectum and / or neoadjuvant therapy.
Who cannot join
- Comorbidities clinically significant where surgical resection and / or neoadjuvant therapy is impossible, according to medical assessment.
- Prior antineoplastic therapy different from neoadjuvant therapy.
- History of Crohn's disease or ulcerative colitis.
- Confirmation or strongly suspected inherited polyp syndrome.
- Pregnant women or during lactation (women of childbearing age should have a negative pregnancy test).
- Concurrent participation in another research protocol involving therapeutic intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Randomized Study of Observation Versus Surgical Resection in Patients With Rectal Cancer Who Achieved Complete Clinical Response After Neoadjuvant Chemoradiotherapy
With the possibility of pathological complete response in surgical specimens, some authors have proposed non-operative management of the patient group, when re-staged after neoadjuvant treatment, have complete clinical response. So far, this approach remains discussed in the literature, and there are still many uncertainties that patients with clinical complete response after chemoradiotherapy in fact no detectable viable tumor and may be omitted of radical surgical treatment. It is a still investigational approach and actually gained space even for patients with very high or who refuse surgery after all clarifications surgical risk.
Hypothesis: The preservation of the rectum in patients with adenocarcinoma of the middle and distal rectum (up to 10 cm) reaching clinical complete response after neoadjuvant chemoradiotherapy have similar rate of the rectal cancer recurrence than patients who underwent surgical rectal resection.
Read more
This will be a prospective, randomized, open label phase II of surgical resection versus conservative treatment (observation) in patients with mid and distal rectal cancer who achieved complete after neoadjuvant chemoradiotherapy combined with clinical response.
The main objective of this study is to assess whether conservative approach is similar to rectosigmoidectomy with complete mesorectal excision or amputation abdminoperineal the rectum in patients with complete clinical response after neoadjuvant therapy combined chemoradiotherapy.
Patient Selection: To be eligible patients who have neoadjuvant prior histologic diagnosis of rectal adenocarcinoma, tumors located within 10 cm from the anal verge, a complete clinical response after treatment with chemoradiotherapy for rectal tumors staged clinical and radiological T3-4 N0 M0 or T (any) N + M0, absence of colorectal synchronous tumors.
Treatment: Eligible patients will be randomized 1:1 to resection of the rectum or notice. The period for randomization of patients will be 12 weeks after the last dose of radiotherapy / chemotherapy, so that we can properly assess the antitumor response as described above. After randomization, patients in the surgical group will undergo resection of the rectum with complete excision of mesorectal within 2 weeks after randomization.
- Conditions
- Rectal Cancer
- Being tested
- Rectal resection, Observation
- Keywords
- Observation, Rectal Resection, complete clinical response, neoadjuvant chemoradiotherapy.
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectal resectionProcedure or surgery
Surgical rectal resection
ObservationOther
| Study group | Role | What they receive |
|---|---|---|
| Rectal resection | Active comparator | Surgical rectal resection Receives: Procedure: Rectal resection |
| Observation | Experimental | Conservative approach Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival (DFS)
Measured: 3 years
Secondary outcomes (1)
Operative complication rate
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startNov 2011
- Primary completionDec 2016
- Study completion23 Apr 2020
Why it stopped: During the execution time foreseen in the project, the expected number of patients was not reached.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ivan Cecconello, MD, Principal investigator, Faculdade de Medicina da USPUlysses Ribeiro, MD, Study director, Instituto do Câncer do Estado de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02052921
- Sponsor's protocol ID
- NP172/11
- Status last verified
- May 2020
- First submitted
- 31 Jan 2014
- Last updated
- 11 May 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Randomized Study of Observation Versus Surgical Resection in Patients With Rectal Cancer Who Achieved Complete Clinical Response After Neoadjuvant Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT02052921
- Acronym / sponsor ID
- NP172/11
- Conditions
- Rectal Cancer
- Keywords
- Observation, Rectal Resection, complete clinical response, neoadjuvant chemoradiotherapy.
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: During the execution time foreseen in the project, the expected number of patients was not reached.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Study start
- Nov 2011 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- 23 Apr 2020 (actual)
- First posted
- 3 Feb 2014 (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.
With the possibility of pathological complete response in surgical specimens, some authors have proposed non-operative management of the patient group, when re-staged after neoadjuvant treatment, have complete clinical response. So far, this approach remains discussed in the literature, and there are still many uncertainties that patients with clinical complete response after chemoradiotherapy in fact no detectable viable tumor and may be omitted of radical surgical treatment. It is a still investigational approach and actually gained space even for patients with very high or who refuse surgery after all clarifications surgical risk.
Hypothesis: The preservation of the rectum in patients with adenocarcinoma of the middle and distal rectum (up to 10 cm) reaching clinical complete response after neoadjuvant chemoradiotherapy have similar rate of the rectal cancer recurrence than patients who underwent surgical rectal resection.
This will be a prospective, randomized, open label phase II of surgical resection versus conservative treatment (observation) in patients with mid and distal rectal cancer who achieved complete after neoadjuvant chemoradiotherapy combined with clinical response.
The main objective of this study is to assess whether conservative approach is similar to rectosigmoidectomy with complete mesorectal excision or amputation abdminoperineal the rectum in patients with complete clinical response after neoadjuvant therapy combined chemoradiotherapy.
Patient Selection: To be eligible patients who have neoadjuvant prior histologic diagnosis of rectal adenocarcinoma, tumors located within 10 cm from the anal verge, a complete clinical response after treatment with chemoradiotherapy for rectal tumors staged clinical and radiological T3-4 N0 M0 or T (any) N + M0, absence of colorectal synchronous tumors.
Treatment: Eligible patients will be randomized 1:1 to resection of the rectum or notice. The period for randomization of patients will be 12 weeks after the last dose of radiotherapy / chemotherapy, so that we can properly assess the antitumor response as described above. After randomization, patients in the surgical group will undergo resection of the rectum with complete excision of mesorectal within 2 weeks after randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rectal resection | Active comparator | Procedure: Rectal resectionSurgical rectal resection |
| Observation | Experimental | Other: ObservationConservative approach |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histological diagnosis of rectal adenocarcinoma
- tumors located within 10 cm from the anal verge by rigid proctoscopy measurement
- Complete clinical response after neoadjuvant treatment with chemoradiotherapy for rectal tumors clinical and radiologically staged as T3-4 N0 M0 or T (any) N + M0
- Absence of colorectal synchronous tumors
- Age between 18 and 75 years
Key exclusion criteria (6 listed)
- Comorbidities clinically significant where surgical resection and / or neoadjuvant therapy is impossible, according to medical assessment.
- Prior antineoplastic therapy different from neoadjuvant therapy.
- History of Crohn's disease or ulcerative colitis.
- Confirmation or strongly suspected inherited polyp syndrome.
- Pregnant women or during lactation (women of childbearing age should have a negative pregnancy test).
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 |
|---|---|---|
| Rectal resectionSurgical rectal resection | Procedure or surgery | Rectal resection |
| Observation | Other | Observation |
Primary outcome
Disease-free survival (DFS)
Time frame: 3 years
1 secondary outcome
Operative complication rate
Time frame: 30 days
Results and safety
The study was stopped early (reason given: During the execution time foreseen in the project, the expected number of patients was not reached.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2020.
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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.
Ivan Cecconello, MD principal investigator
Faculdade de Medicina da USP
Ulysses Ribeiro, MD study director
Instituto do Câncer do Estado de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rectal resection and Observation 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 9 inclusion and 6 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: stopped early, as of the sponsor's last update on 11 May 2020. 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.
Are results available for this study?
The study was stopped early (reason given: During the execution time foreseen in the project, the expected number of patients was not reached.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (DFS) (time frame: 3 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 11 May 2020.