Rectal CancerPhase 3GRECCAR1NCT00979680
Sphincter-preserving Surgery After Preoperative Treatment of Ultra-low Rectal Carcinoma
A Phase 3 study testing High-Dose radiotherapy and Chemo-radiotherapy in people with Rectal Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 12 sites in France.
Trial summary
This phase III trial included patients with low rectal adenocarcinoma which initially required APR, with a mean clinical distance between the tumor inferior pole and the levator ani of 0.5 cm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- High-Dose radiotherapy and Chemo-radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 12 sitesFrance
- Study dates
- Apr 2001to Sep 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adenocarcinoma of ultra-low rectum at high risk of abdomino-périneal amputation
- Tumor classified as EER UT2-UT3, whatever the nodal status
- pathological confirmation of rectal adenocarcinoma without evidence of distant metastasis (M0), T2 or T3 resectable tumors without striated sphincter involvement and with the inferior margin of the tumor located less than 2 cm from the upper part of the levator ani.
- Age 18 years or older
- Informed and written consent
Who cannot join
- T1
- T4 (proven invasion of sphincter)
- Diffuse metastatic syndrome (no curative intent, short expected life span)
- preoperative incontinence (non due to the tumor)
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Institut Sainte catherine
Avignon
Hopital Saint Andre
Bordeaux
Hotel Dieu
Clermont-Ferrand
Hopital Michallon
Grenoble
Centre Oscar Lambret
Lille
CAC Léon Bérard
Lyon
Institut Paoli Calmettes
Marseille
CRLC Val d'Aurelle
Montpellier
Hopital Saint Eloi
Montpellier
Centre Rene Gauducheau
Nantes
Centre Paul Strauss
Strasbourg
Institut Gustave Roussy
Villejuif
About this study
Official title: Phase II Trial Comparing Two Neoadjuvant Treatments in Patients With Ultra-low Rectal Cancer: High-dose Radiotherapy Versus Radio-chemotherapy
This phase III trial included patients with low rectal adenocarcinoma which initially required APR, with a mean clinical distance between the tumor inferior pole and the levator ani of 0.5 cm. Patients were randomly assigned to receive high-dose radiation (45 + 18 Gy) or radiochemotherapy (45 Gy + 5FU continuous infusion). The surgical decision was based on the tumor status at surgery. All surgeons used a homogenous SSR technique such as intersphincteric resection. The primary endpoint was the SSR rate.
- Conditions
- Rectal Cancer
- Being tested
- High-Dose radiotherapy, Chemo-radiotherapy
- Keywords
- sphincter preservation, neoadjuvant therapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Dose radiotherapyRadiation
Also called HDRT
Preoperative radiotherapy of 45 Gy/25 fractions of 1.8 Gy through three fields was delivered to the pelvis over 5 weeks, followed by a 18 Gy/10 fraction boost to the primary tumor over 2 weeks.
Chemo-radiotherapyRadiation
Also called CTRT
Chemotherapy (5-fluorouracil, 200 mg per square meter of body-surface area per day) was delivered over 5 weeks concurrently with the pelvic radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| High-dose Radiotherapy | Active comparator | Not described Receives: Radiation: High-Dose radiotherapy |
| Chemo-radiotherapy | Active comparator | Not described Receives: Radiation: Chemo-radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sphincter preservation rate
Measured: surgery
Secondary outcomes (7)
Tumor response according to rectal endo-echography
Measured: prior to surgery
operative mortality and morbidity
Measured: after surgery
anatomopathology margins (lateral and inferior)
Measured: after surgery
Functional results (stoma closure, continence, manometry)
Measured: 2 years
Local recurrence
Measured: 3 years
Disease-free survival
Measured: 3 years
Overall Survival
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2009 (estimated)
- Study startApr 2001
- Study completionSep 2007
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.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe sponsor's other registered studies.
- 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
- 207 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- Philippe Rouanet, Pr, Principal investigator, CRLC Val d'Aurelle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00979680
- Sponsor's protocol ID
- KBR-2001
- Acronym
- GRECCAR1
- Status last verified
- Jun 2023
- First submitted
- 17 Sep 2009
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial Comparing Two Neoadjuvant Treatments in Patients With Ultra-low Rectal Cancer: High-dose Radiotherapy Versus Radio-chemotherapy
- ClinicalTrials.gov ID
- NCT00979680
- Acronym / sponsor ID
- GRECCAR1 / KBR-2001
- Conditions
- Rectal Cancer
- Keywords
- sphincter preservation, neoadjuvant therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- Apr 2001
- Study completion
- Sep 2007 (actual)
- First posted
- 18 Sep 2009 (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.
This phase III trial included patients with low rectal adenocarcinoma which initially required APR, with a mean clinical distance between the tumor inferior pole and the levator ani of 0.5 cm. Patients were randomly assigned to receive high-dose radiation (45 + 18 Gy) or radiochemotherapy (45 Gy + 5FU continuous infusion). The surgical decision was based on the tumor status at surgery. All surgeons used a homogenous SSR technique such as intersphincteric resection. The primary endpoint was the SSR rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-dose Radiotherapy | Active comparator | Radiation: High-Dose radiotherapy |
| Chemo-radiotherapy | Active comparator | Radiation: Chemo-radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adenocarcinoma of ultra-low rectum at high risk of abdomino-périneal amputation
- Tumor classified as EER UT2-UT3, whatever the nodal status
- pathological confirmation of rectal adenocarcinoma without evidence of distant metastasis (M0), T2 or T3 resectable tumors without striated sphincter involvement and with the inferior margin of the tumor located less than 2 cm from the upper part of the levator ani.
- Age 18 years or older
- Informed and written consent
Key exclusion criteria (4 listed)
- T1
- T4 (proven invasion of sphincter)
- Diffuse metastatic syndrome (no curative intent, short expected life span)
- preoperative incontinence (non due to the tumor)
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 |
|---|---|---|
| High-Dose radiotherapyAlso: HDRTPreoperative radiotherapy of 45 Gy/25 fractions of 1.8 Gy through three fields was delivered to the pelvis over 5 weeks, followed by a 18 Gy/10 fraction boost to the primary tumor over 2 weeks. | Radiation | High-dose Radiotherapy |
| Chemo-radiotherapyAlso: CTRTChemotherapy (5-fluorouracil, 200 mg per square meter of body-surface area per day) was delivered over 5 weeks concurrently with the pelvic radiotherapy. | Radiation | Chemo-radiotherapy |
Primary outcome
Sphincter preservation rate
Time frame: surgery
7 secondary outcomes
Tumor response according to rectal endo-echography
Time frame: prior to surgery
operative mortality and morbidity
Time frame: after surgery
anatomopathology margins (lateral and inferior)
Time frame: after surgery
Functional results (stoma closure, continence, manometry)
Time frame: 2 years
Local recurrence
Time frame: 3 years
Disease-free survival
Time frame: 3 years
Overall Survival
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
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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.
Philippe Rouanet, Pr principal investigator
CRLC Val d'Aurelle
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing High-Dose radiotherapy and Chemo-radiotherapy in people with Rectal Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 12 sites in France.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sphincter preservation rate (time frame: surgery). 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 29 Jun 2023.