BReak Interval Delayed Surgery for Gastrointestinal Extraperitoneal Rectal Cancer

NCT03581344 | Unknown

• 1 other identifier: 1908
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

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

Rectal Cancer

Keywords

Conservative Treatment; Neoadjuvant Therapy; Radiotherapy

Outcome Measures

Primary Outcomes (2)

• Complete response (CR) ypT0N0

  Absence of tumoral cells in the rectum and mesorectal nodes, examined by the pathologist

  9-16 weeks: surgery

• TRG (Tumor Regression Grade)

  Histological assessment of the response of rectal cancer to neoadjuvant treatment

  9-16 weeks: surgery

Secondary Outcomes (10)

• Overall survival

  24-60 months

• Disease free survival

  24-60 months

• Local recurrence free survival

  24-60 months

• Metastasis free survival

  24-60 months

• Concordance between major clinical response (ymCR) or complete clinical response (ycCR) at imaging and ypCR

  24-60 months

Study Arms (2)

Control arm

NO INTERVENTION

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.

Experimental arm

EXPERIMENTAL

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.)

Diagnostic Test: Repetition of Re-staging

Interventions

Repetition of Re-staging DIAGNOSTIC_TEST

Second clinical and instrumental re-evaluation after 11-12 weeks and then surgery 13-16 weeks after the end of chemoradiotherapy if major or complete response at 7-8 weeks

Experimental arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione policlinico universitario a. gemelli IRCCS

Rome, 00164, Italy

RECRUITING

Related Publications (1)

• Chiloiro 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 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Maria Antonietta Gambacorta

CONTACT

(+39)0630155339; mariaantonietta.gambacorta@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD

Model Details: The Patients included in the study will undergo a chemoradiotherapy neoadjuvant treatment. Patients will undergo a clinical-instrumental restaging at 7-8 weeks and will be randomized in two groups in case of major or complete response: 1. Surgery 9-11 weeks after the end of neoadjuvant treatment 2. Second clinical and instrumental re-evaluation after 11-12 weeks and then surgery 13-16 weeks after the end of chemoradiotherapy.

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: July 10, 2018
• Study Start: October 1, 2018
• Primary Completion: September 17, 2023
• Study Completion: September 17, 2023
• Last Updated: January 11, 2022

Record last verified: 2021-12

Locations

IT (1)