Loading clinical trials...

Short-course Radiation Followed by mFOLFOX-6 Plus COMPOUND 2055269 for Locally-advanced Rectal Adenocarcinoma | Clinical Trials | Clareo Health

UNKNOWNPHASE2

Short-course Radiation Followed by mFOLFOX-6 Plus COMPOUND 2055269 for Locally-advanced Rectal Adenocarcinoma

NCT03503630•Ali Shamseddine

View on ClinicalTrials.gov

Summary

Detailed Description

The purpose of this study is to show that the addition of COMPOUND 2055269, an immunotherapeutic drug, to Folfox chemotherapy will improve the pathologic complete response rate in patients with locally advanced rectal cancer. COMPOUND 2055269 has demonstrated meaningful clinical activity across various tumor types and treatment settings. No clinical trial is conducted over COMPOUND 2055269 in locally-advanced rectal adenocarcinoma.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients aged ≥18 years.
•2. Locally-advanced rectal cancer (cT2 N1-3, cT3 N0-3, evidence of extramural vascular or mesorectal fascia involvement).
•3. \<12 cm from anal verge.
•4. Histologically proven rectal adenocarcinoma.
•5. ECOG performance score ≤ 1.
•6. Have adequate organ function by meeting the following:
•* Absolute neutrophil count (ANC) ≥ 1.5 × 109/L;
•* Platelet count ≥ 100 × 109/L;
•* Hemoglobin ≥ 9 g/dL;
•* Total bilirubin level ≤ 1.5 × the upper limit of normal (ULN) range;
+4 more criteria

Exclusion Criteria

•1. Distant metastasis (M1).
•2. Patients with T2 N0 or T4.
•3. Recurrent rectal cancer.
•4. Symptoms or history of peripheral neuropathy.
•5. Prior radiotherapy or chemotherapy.
•6. Current use of immunosuppressive medication, except for the following:
•* Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intraarticular injection);
•* Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent;
•* Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
•7. Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.
+16 more criteria

Locations (3)

King Hussein Cancer Center

Amman, Jordan

American University of Beirut Medical Center

Beirut, Lebanon

Hôtel Dieu de France

Beirut, Lebanon

Key Dates

Start Date

July 20, 2018

Primary Completion Date

March 15, 2021

Completion Date

July 2, 2024

Last Updated

January 31, 2024

Enrollment

ACTUAL participants

Conditions

Locally Advanced Rectal Cancer

Interventions

COMPOUND 2055269

DRUG

Radiation Therapy

RADIATION

mFOLFOX

DRUG

Total Mesorectal Excision

PROCEDURE

SMART TNT for the Conservative Management of Locally Advanced Rectal Cancer

NCT05412082

Locally Advanced Rectal Cancer

View study

RECRUITINGPHASE2

Node-sparing Radiotherapy Combined with Total Neoadjuvant CAPOX and Sintilimab for MSS Middle and Low Rectal Cancer

NCT06204094

Locally Advanced Rectal Cancer

View study

RECRUITINGPHASE2

Consolidation Versus Induction Chemotherapy in Total Neoadjuvant Therapy of Rectal Cancer With High Risk for Recurrence

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 31, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Short-course Radiation Followed by mFOLFOX-6 Plus COMPOUND 2055269 for Locally-advanced Rectal Adenocarcinoma

Inclusion Criteria

Exclusion Criteria

SMART TNT for the Conservative Management of Locally Advanced Rectal Cancer

Node-sparing Radiotherapy Combined with Total Neoadjuvant CAPOX and Sintilimab for MSS Middle and Low Rectal Cancer

Consolidation Versus Induction Chemotherapy in Total Neoadjuvant Therapy of Rectal Cancer With High Risk for Recurrence

A Pospective, Single-arm, Multicenter Clinical Trial Evaluating Preoperative Neoadjuvant mFOLFOX6 Chemotherapy in Combination With PD1 Monoclonal Antibody in MSS/pMMR Locally Advanced Rectal Cancer

Intraoperative Electron Radiotherapy in Rectal Cancer - A Feasibility Trial

Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for pMMR/MSS Locally Advanced Mid-low Rectal Cancer