Clinical trial · Interventional
BReak Interval Delayed Surgery for Gastrointestinal Extraperitoneal Rectal Cancer
Evaluation of the Interval Between Chemoradiotherapy and Surgery on Locally Advanced Rectal Cancer Response:a Multicentric Randomized Phase III Study
- 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)
This is a randomized multicentric clinical trial in patients affected by resectable rectal cancer, cT2N1-2, cT3N0-2, MRF -, aiming to evaluate the impact of the interval between chemoradiotherapy and surgery on the pathological response. Patients will undergo a neoadjuvant chemoradiotherapy treatment and those achieving a major or complete clinical and instrumental response will then be randomized and submitted to surgery with two options: the first group will be operated after an interval of 9-11 weeks, while the second will undergo surgery at 13-16 weeks, after a further clinical and instrumental re-evaluation 11-12 weeks after the end of chemoradiotherapy.
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 Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Repetition of Re-staging | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control arm
- description
- Patients undergoing surgery 9-11 weeks after the end of chemoradiotherapy, whose major/complete response has to be assessed with clinical-instrumental exams to be performed 7-8 weeks after the end of chemoradiotherapy.
- type
- EXPERIMENTAL
- label
- Experimental arm
- description
- Patients undergoing surgery 13-16 weeks after the end of chemoradiotherapy, (length of surgical interval ) showing a major/complete response at the clinical-instrumental exams to be performed 7-8 weeks after the end of chemoradiotherapy. These patients will undergo a repetition of re-staging (a second clinical and instrumental re-evaluation after 11-12 weeks and then surgery 13-16 weeks after the end of chemoradiotherapy.)
- interventionNames
- Diagnostic Test: Repetition of Re-staging
Primary outcomes (2)
- measure
- Complete response (CR) ypT0N0
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * ECOG Performance Status 0-1 * Histological confirmation of Adenocarcinoma * Rectal tumor localized within 12 cm from the internal anal sphincter (IAS) * Clinical stage cT2N1-2, M0; cT3, N0-N2, M0 and MRF - , EMVI - * Absence of major comorbidities contraindicating oncological treatments * Major/complete clinical-instrumental response after CRT treatment * Informed consent acquisition Exclusion Criteria: * cT4 and/or mesorectal fascia involvement (MRF+) and or EMVI + * T localized at a distance \> 12 cm from the internal anal sphincter (IAS) * Presence of extramesorectal nodes * Presence of distant metastases * Pregnancy or breastfeeding status * Diagnosis of tumor in other sites treated within the last five years, with the exception of basal cell skin carcinoma or in situ carcinoma of the cervix * Absolute contraindication to pelvic radiotherapy, chemotherapy and/or surgery * Contraindication to magnetic resonance imaging and/or endoscopy * Informed consent absence * Partial response, "no-change" or disease progression at restaging after 7-8 weeks from CRT end
References
Publications (1)
- DERIVEDChiloiro G, Meldolesi E, Corvari B, Romano A, Barbaro B, Coco C, Crucitti A, Genovesi D, Lupattelli M, Mantello G, Menghi R, Falchetto Osti M, Persiani R, Petruzziello L, Ricci R, Sofo L, Valentini C, De Paoli A, Valentini V, Antonietta Gambacorta M. BRIDGE -1 TRIAL: BReak Interval Delayed surgery for Gastrointestinal Extraperitoneal rectal cancer, a multicentric phase III randomized trial. Clin Transl Radiat Oncol. 2022 Mar 8;34:30-36. doi: 10.1016/j.ctro.2022.03.002. eCollection 2022 May. PMID 35340685