Clinical trial · Interventional
Local Excision in Downstaged Rectal Cancer
Phase III Randomized Trial of Local Excision Versus Total Mesorectal Excision in Downstaged T2T3 Low Rectal Cancer After Radiochemotherapy
NCT00427375CI-TRIAL-00032077GRECCAR 2completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| local rectal excision | Procedure | — | UNRESOLVED |
| total mesorectal excision | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- New surgical option in good responders after neoadjuvant treatment for low rectal cancer
- interventionNames
- Procedure: local rectal excision
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Standard surgery
- interventionNames
- Procedure: total mesorectal excision
Primary outcomes (1)
- 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
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (3)
- DERIVEDTeste 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. PMID 34097005
- DERIVEDRullier 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. PMID 32043980
- DERIVEDRullier 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. PMID 28601342