Rectal NeoplasmsPhase 3GRECCAR 2NCT00427375
Local Excision in Downstaged Rectal Cancer
A Phase 3 study testing local rectal excision and total mesorectal excision in people with Rectal Neoplasms, run by University Hospital, Bordeaux at 40 sites in France.
Trial summary
Patients with T2T3 low rectal cancer (size =< 4 cm) received neoadjuvant treatment (50Gy in 5 weeks with concomitant chemotherapy. Good responders (residual tumour =< 2 cm) are randomised in local vs rectal excision, 6-8 weeks after treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Neoplasms
- What is being tested?
- local rectal excision and total mesorectal excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 40 sitesFrance
- Study dates
- 5 Mar 2007to 8 Feb 2018
- 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
- T2T3 low adenocarcinoma of the rectum
- Tumour size =< 4cm
- Less than 8 cm from the anal verge
- No metastatic disease
- Patient is at least 18 years of age
- ECOG performance status score =< 2
- Patient and doctor have signed informed consent
- inclusion criteria : Residual clinical tumour size =< 2cm after radiochemotherapy
Who cannot join
- T1, T4 tumour or anal sphincter invasion
- Metastatic disease (M1)
- Contra indication for radiotherapy and/or fluoropyrimidine use in chemotherapy
- History of cancer
- Symptomatic cardiac or coronary insufficiency
- Severe renal insufficiency
- Peripheral neuropathy
- Patient included in a trial
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
France40 sites
Centre Radiothérapie Oncologie Moyenne Garonne - 13 Quai du Docteur Calabet
Agen, 47000
Polyclinique Sainte marguerite
Auxerre, 89000
Service de Chirurgie Viscérale, Digestive et Cancérologique - CHRU J.Minoz - Boulevard Fleming
Besançon, 25030
Service de Radiothérapie - Clinique Tivoli - 220 rue Mandron
Bordeaux, 33000
Service de chirurgie digestive - hôpital Saint André - 1 rue Jean Burguet
Bordeaux, 33075
Service de Chirurgie Oncologique - Institut Bergonié - 229, cours de l'Argonne
Bordeaux, 33076
Service de Chirurgie Digestive - Hôpital ambroise Paré - 9 avenue Charles de Gaulle
Boulogne-Billancourt, 92100
Service de Chirurgie Générale et Digestive - Hôtel Dieu - CHU Clermont-Ferrand - Boulevard Léon Malfreyt
Clermont-Ferrand, 63000
Département de Radiothérapie - Centre Jean Perrin - 58 rue Montalembert
Clermont-Ferrand, 63011
Service de Chirurgie Générale et Digestive - Hôpital Beaujon - 100 boulevard du Général Leclerc
Clichy, 92110
Centre d'Oncologie et Radiothérapie - rue du Dr Schweitzer
La Rochelle, 17000
Service de Chirurgie Digestive - Hôpital A. Michallon - CHU de Grenoble - Boulevard de la Chantourne
La Tronche, 38700
Département de Chirurgie Oncologique - Centre Oscar Lambret - 3 rue Combemale
Lille, 59020
Service de Chirurgie Générale - Hôpitaux Civils de Lyon
Lyon, 69317
Département de Chirurgie Oncologique - Centre Léon Bérard - 28 rue Laennec
Lyon, 69373
Institut Paoli Calmette
Marseille, 13009
Service de Chirurgie Digestive et viscérale - CHU Timone - 264 rue Saint Pierre
Marseille, 13385
Département de Chirurgie Oncologique - CRLC Val d'Aurelle
Montpellier, 34298
CHU Nantes
Nantes, 44000
Service d'Oncologie-Radiothérapie - Centre antoine Lacassagne - 33 avenue de Valombrose
Nice, 06189
Service de Chirurgie Générale - Hôpital Archet II
Nice, 06202
CHU Nîmes
Nîmes, 30029
Département Médico-Chirurgical de Pathologie Digestive - Hôpital Lariboisière - 2 rue Ambroise Paré
Paris, 75010
Service de Cancérologie - Radiothérapie - Hôpital Saint-Louis - 1 avenue Claude Vellefeaux
Paris, 75010
Service de Chirurgie Digestive - Hôpital des Diaconnesses - la Croix Saint-Simon - 125 rue d'Avron
Paris, 75010
Service de Chirurgie Générale et Digestive - Hôpital Saint-Antoine - 184 rue du Faubourg Saint-Antoine
Paris, 75012
Service d'Oncologie - Radiothérapie - Hôpital Tenon - 4 rue de la Chine
Paris, 75970
Service de Radiothérapie - Oncologie - Centre Hospitalier Lyon Sud - Hôpitaux Civils de Lyon - 165 chemin du Grand Revoyet
Pierre-Bénite, 69495
Service de Chirurgie Viscérale - CHU pontchaillou - 2 rue Henri Le Guilloux
Rennes, 35033
Département des Radiations - Centre Eugène Marquis - rue de la Bataille Flandres-Dunkerque
Rennes, 35042
Service de Chirurgie Digestive - CHU Charles Nicolle - 1 rue Germont
Rouen, 76031
Service de Radiothérapie-Oncologie - centre Henri Becquerel - rue d'Amiens
Rouen, 76038
Service de Chirurgie Oncologique - Centre René Gauducheau - Boulevard Jacques Monod
Saint-Herblain, 44805
Service de Chirurgie Viscérale - Clinique Charcot - 51-52 rue Commandant Charcot
Sainte-Foy-lès-Lyon, 69110
Département de Radiothérapie - Centre Paul Strauss - 3 rue de la Porte de l'Hôpital
Strasbourg, 67065
Service de Chirurgie Digestive - Hôpital Hautepierre
Strasbourg, 67200
Département d'Oncologie Médicale - Institut Claudius Régaud - 20-24 rue du Pont Saint Pierre
Toulouse, 31052
Service de Chirurgie Digestive - Hôpital Purpan - Place du Docteur Baylac
Toulouse, 31059
Département de Chirurgie Oncologique - Centre Alexis Vautrin - Avenue de Bourgogne
Vandœuvre-lès-Nancy, 54511
Service de Chirurgie Digestive et Générale - CHU Brabois - avenue de Bourgogne
Vandœuvre-lès-Nancy, 54511
About this study
Official title: Phase III Randomized Trial of Local Excision Versus Total Mesorectal Excision in Downstaged T2T3 Low Rectal Cancer After Radiochemotherapy
Patients with T2T3 low rectal cancer (size =< 4 cm) received neoadjuvant treatment (50Gy in 5 weeks with concomitant chemotherapy. Good responders (residual tumour =< 2 cm) are randomised in local vs rectal excision, 6-8 weeks after treatment. The composite end point evaluates the rate of patients with death, recurrence, major morbidity or severe after effects at two years.
Read the detailed description
Rectal excision is the standard surgical treatment of rectal cancer. The risk of mortality and major short and long term morbidity induced by rectal excision justifies new treatments. Local excision is a conservative alternative approach associated with low mortality and morbidity. The purpose of this prospective randomised multicenter study is to compare local vs rectal excision in good responders after radiochemotherapy for low rectal cancer.
Patients with T2T3 low rectal cancer, less than 8 cm from the anal verge, size =< 4 cm, received neoadjuvant treatment, included radiotherapy between 45-55Gy in 5 weeks with concomitant chemotherapy consist of at least, one fluoropyrimidine.
Good clinical responders (residual tumour =< 2 cm) are randomised in local vs rectal excision, 6-8 weeks after treatment. In case of not confirmed pathological response following local excision, complementary rectal excision is required.
Bad responders (residual tumour > 2cm) are treated by primary rectal excision. Follow-up includes digital rectal examination, CT-scan and endorectal ultrasound (if local excision) every 4 months for 2 years, then every 6 months for 3 years.
- Conditions
- Rectal Neoplasms
- Being tested
- local rectal excision, total mesorectal excision
- Keywords
- Rectal cancer surgery, Neoadjuvant radiochemotherapy, Randomized clinical trial, Multicenter study
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local rectal excisionProcedure or surgery
New surgical option in good responders after neoadjuvant treatment for low rectal cancer
total mesorectal excisionProcedure or surgery
standard surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | New surgical option in good responders after neoadjuvant treatment for low rectal cancer Receives: Procedure: local rectal excision |
| 2 | Active comparator | Standard surgery Receives: Procedure: total mesorectal excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the proportion of patients presenting at least 1 component of the composite outcome (4 components: death, recurrence, major morbidity and severe after effects) at 2 years after
Measured: 24 months
Secondary outcomes (3)
Compare the incidence at 2 years of each component separately: death, recurrence, major morbidity and severe after effect
Measured: 24 months
5-year survival.
Measured: 5 years
Quality of life (QLQ C30 - CR38)
Measured: at 0, 4, 8 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2007 (estimated)
- Study start5 Mar 2007
- Primary completionDec 2014
- Study completion8 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi, Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Eric RULLIER, Pr., Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00427375
- Sponsor's protocol ID
- CHUBX 2006/03
- Other IDs
- 2005-025
- Acronym
- GRECCAR 2
- Status last verified
- Mar 2018
- First submitted
- 26 Jan 2007
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Teste B, Rouanet P, Tuech JJ, Valverde A, Lelong B, Rivoire M, Faucheron JL, Jafari M, Portier G, Meunier B, Sielezneff I, Prudhomme M, Marchal F, Dubois A, Capdepont M, Denost Q, Rullier E. Early and late morbidity of local excision after chemoradiotherapy for rectal cancer. BJS Open. 2021 May 7;5(3):zrab043. doi: 10.1093/bjsopen/zrab043.
PubMed 34097005Rullier E, Vendrely V, Asselineau J, Rouanet P, Tuech JJ, Valverde A, de Chaisemartin C, Rivoire M, Trilling B, Jafari M, Portier G, Meunier B, Sieleznieff I, Bertrand M, Marchal F, Dubois A, Pocard M, Rullier A, Smith D, Frulio N, Frison E, Denost Q. Organ preservation with chemoradiotherapy plus local excision for rectal cancer: 5-year results of the GRECCAR 2 randomised trial. Lancet Gastroenterol Hepatol. 2020 May;5(5):465-474. doi: 10.1016/S2468-1253(19)30410-8. Epub 2020 Feb 7.
PubMed 32043980Rullier E, Rouanet P, Tuech JJ, Valverde A, Lelong B, Rivoire M, Faucheron JL, Jafari M, Portier G, Meunier B, Sileznieff I, Prudhomme M, Marchal F, Pocard M, Pezet D, Rullier A, Vendrely V, Denost Q, Asselineau J, Doussau A. Organ preservation for rectal cancer (GRECCAR 2): a prospective, randomised, open-label, multicentre, phase 3 trial. Lancet. 2017 Jul 29;390(10093):469-479. doi: 10.1016/S0140-6736(17)31056-5. Epub 2017 Jun 7.
PubMed 28601342
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Trial of Local Excision Versus Total Mesorectal Excision in Downstaged T2T3 Low Rectal Cancer After Radiochemotherapy
- ClinicalTrials.gov ID
- NCT00427375
- Acronym / sponsor ID
- GRECCAR 2 / CHUBX 2006/03
- Conditions
- Rectal Neoplasms
- Keywords
- Rectal cancer surgery, Neoadjuvant radiochemotherapy, Randomized clinical trial, Multicenter study
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Sanofi, Roche Pharma AG
- Study start
- 5 Mar 2007 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- 8 Feb 2018 (actual)
- First posted
- 29 Jan 2007 (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.
Patients with T2T3 low rectal cancer (size =< 4 cm) received neoadjuvant treatment (50Gy in 5 weeks with concomitant chemotherapy. Good responders (residual tumour =< 2 cm) are randomised in local vs rectal excision, 6-8 weeks after treatment. The composite end point evaluates the rate of patients with death, recurrence, major morbidity or severe after effects at two years.
Detailed description
Rectal excision is the standard surgical treatment of rectal cancer. The risk of mortality and major short and long term morbidity induced by rectal excision justifies new treatments. Local excision is a conservative alternative approach associated with low mortality and morbidity. The purpose of this prospective randomised multicenter study is to compare local vs rectal excision in good responders after radiochemotherapy for low rectal cancer.
Patients with T2T3 low rectal cancer, less than 8 cm from the anal verge, size =< 4 cm, received neoadjuvant treatment, included radiotherapy between 45-55Gy in 5 weeks with concomitant chemotherapy consist of at least, one fluoropyrimidine.
Good clinical responders (residual tumour =< 2 cm) are randomised in local vs rectal excision, 6-8 weeks after treatment. In case of not confirmed pathological response following local excision, complementary rectal excision is required.
Bad responders (residual tumour > 2cm) are treated by primary rectal excision. Follow-up includes digital rectal examination, CT-scan and endorectal ultrasound (if local excision) every 4 months for 2 years, then every 6 months for 3 years.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: local rectal excisionNew surgical option in good responders after neoadjuvant treatment for low rectal cancer |
| 2 | Active comparator | Procedure: total mesorectal excisionStandard surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- T2T3 low adenocarcinoma of the rectum
- Tumour size =< 4cm
- Less than 8 cm from the anal verge
- No metastatic disease
- Patient is at least 18 years of age
Key exclusion criteria (8 listed)
- T1, T4 tumour or anal sphincter invasion
- Metastatic disease (M1)
- Contra indication for radiotherapy and/or fluoropyrimidine use in chemotherapy
- History of cancer
- Symptomatic cardiac or coronary insufficiency
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 |
|---|---|---|
| local rectal excisionNew surgical option in good responders after neoadjuvant treatment for low rectal cancer | Procedure or surgery | 1 |
| total mesorectal excisionstandard surgery | Procedure or surgery | 2 |
Primary outcome
Compare the proportion of patients presenting at least 1 component of the composite outcome (4 components: death, recurrence, major morbidity and severe after effects) at 2 years after
Time frame: 24 months
3 secondary outcomes
Compare the incidence at 2 years of each component separately: death, recurrence, major morbidity and severe after effect
Time frame: 24 months
5-year survival.
Time frame: 5 years
Quality of life (QLQ C30 - CR38)
Time frame: at 0, 4, 8 and 12 months
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 14 Mar 2018.
- Derived from this study: PubMed 34097005Teste B, Rouanet P, Tuech JJ, Valverde A, Lelong B, Rivoire M, Faucheron JL, Jafari M, Portier G, Meunier B, Sielezneff I, Prudhomme M, Marchal F, Dubois A, Capdepont M, Denost Q, Rullier E. Early and late morbidity of local excision after chemoradiotherapy for rectal cancer. BJS Open. 2021 May 7;5(3):zrab043. doi: 10.1093/bjsopen/zrab043.
- Derived from this study: PubMed 32043980Rullier E, Vendrely V, Asselineau J, Rouanet P, Tuech JJ, Valverde A, de Chaisemartin C, Rivoire M, Trilling B, Jafari M, Portier G, Meunier B, Sieleznieff I, Bertrand M, Marchal F, Dubois A, Pocard M, Rullier A, Smith D, Frulio N, Frison E, Denost Q. Organ preservation with chemoradiotherapy plus local excision for rectal cancer: 5-year results of the GRECCAR 2 randomised trial. Lancet Gastroenterol Hepatol. 2020 May;5(5):465-474. doi: 10.1016/S2468-1253(19)30410-8. Epub 2020 Feb 7.
- Derived from this study: PubMed 28601342Rullier E, Rouanet P, Tuech JJ, Valverde A, Lelong B, Rivoire M, Faucheron JL, Jafari M, Portier G, Meunier B, Sileznieff I, Prudhomme M, Marchal F, Pocard M, Pezet D, Rullier A, Vendrely V, Denost Q, Asselineau J, Doussau A. Organ preservation for rectal cancer (GRECCAR 2): a prospective, randomised, open-label, multicentre, phase 3 trial. Lancet. 2017 Jul 29;390(10093):469-479. doi: 10.1016/S0140-6736(17)31056-5. Epub 2017 Jun 7.
- Individual participant dataSharing planned: No
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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.
Eric RULLIER, Pr. principal investigator
University Hospital, Bordeaux
40 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 local rectal excision and total mesorectal excision in people with Rectal Neoplasms, run by University Hospital, Bordeaux at 40 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 8 inclusion and 8 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 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 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?
Compare the proportion of patients presenting at least 1 component of the composite outcome (4 components: death, recurrence, major morbidity and severe after effects) at 2 years after (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00427375, which also lists 3 linked publications.
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 14 Mar 2018.