NCT00227747 is a Phase 3 clinical trial of capecitabine in Colorectal Cancer, sponsored by UNICANCER.

Who is sponsoring NCT00227747?

NCT00227747 is sponsored by UNICANCER.

What drugs are being tested in NCT00227747?

Interventions in NCT00227747: capecitabine, oxaliplatin, conventional surgery, neoadjuvant therapy, radiation therapy.

What condition does NCT00227747 study?

NCT00227747 studies Colorectal Cancer.

Is NCT00227747 still recruiting?

NCT00227747 is currently completed. Last updated 17 February 2021.

Last reviewed 2021-02-17 · How we verify

NCT00227747

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Radiation Therapy and Capecitabine With or Without Oxaliplatin in Treating Patients Who Are Undergoing Surgery for Stage II or Stage III Rectal Cancer

Completed Phase 3 Last updated 17 February 2021

What this trial tests

Phase 3 trial testing capecitabine in Colorectal Cancer in 598 participants. Completed in 15 July 2013.

Timeline

8 November 2005

Primary endpoint
22 October 2008

15 July 2013

Quick facts

Lead sponsor	UNICANCER
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	598
Start date	8 November 2005
Primary completion	22 October 2008
Estimated completion	15 July 2013
Sites	69 locations across France

Drugs / interventions tested

capecitabine (capecitabine) — full drug profile →
oxaliplatin (Oxaliplatin) — full drug profile →
conventional surgery
neoadjuvant therapy — full drug profile →
radiation therapy — full drug profile →

Conditions studied

Colorectal Cancer — all drugs for Colorectal Cancer →

Sponsor

UNICANCER — full company profile →

Who can join

Adults 18 to 80, any sex, with Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving radiation therapy together with combination chemotherapy before surgery may shrink the tumor so it can be removed. It is not yet known whether giving radiation therapy together with capecitabine is more effective with or without oxaliplatin before surgery in treating rectal cancer. PURPOSE: This randomized phase III trial is studying radiation therapy, capecitabine, and oxaliplatin to see how well they work compared to radiation therapy and capecitabine in treating patients who are undergoing surgery for stage II or stage III rectal cancer.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Late toxicities and clinical outcome at 5 years of the ACCORD 12/0405-PRODIGE 02 trial comparing two neoadjuvant chemoradiotherapy regimens for intermediate-risk rectal cancer.
Azria D, Doyen J, Jarlier M, Martel-Lafay I, et al · · 2017 · cited 72× · PMID 28961836 · DOI 10.1093/annonc/mdx351
A management of patients achieving clinical complete response after neoadjuvant therapy and perspectives: on locally advanced rectal cancer.
Liu YX, Yang XR, Peng LQ, Li ZH. · · 2024 · PMID 39845322 · DOI 10.3389/fonc.2024.1450994
Accomplishments in 2008 in the adjuvant treatment of rectal cancer.
Czito B, Lordick F. · · 2009 · PMID 20011572

Verify or expand the search:

Other trials of capecitabine

Trials testing the same drug.

NCT07303283 — Becotatug Vedotin as Adjuvant Therapy For High-risk Nasopharyngeal Carcinoma · Phase 2 · not yet recruiting
NCT07177794 — Consolidation of Toripalimab and Capecitabine After Chemoradiotherapy in ESCC · Phase 3 · not yet recruiting
NCT06685289 — Donafenib Combined With Capecitabine for Postoperative Adjuvant Therapy of Biliary Malignant Tumors With High-risk Recur · Phase 2 · recruiting
NCT06802666 — Short-course Radiotherapy Followed by AK112 and CAPOX as Neoadjuvant Therapy for Locally Advanced Rectal Cancer · Phase 2 · recruiting
NCT06607276 — Phase 2 Trial of Adjuvant Adebrelimab Combined With Capecitabine in High-Risk Resected Cholangiocarcinoma: ACHIEVE · Phase 2 · recruiting

Other recruiting trials for Colorectal Cancer

Currently open trials in the same condition.

NCT07152821 — Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcino · Phase 3 · recruiting
NCT07353645 — KRAS Neoantigen Nanovaccine as Adjuvant Therapy for Colorectal Cancer/Pancreatic Cancer · Phase 1, PHASE2 · recruiting
NCT07432633 — [18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications · Phase 1, PHASE2 · recruiting
NCT07523919 — Functional and Respiratory Determinants of Long-Term Colorectal Cancer Outcomes · recruiting
NCT07529301 — Functional and Respiratory Predictors of Early Postoperative Outcomes · recruiting

Other UNICANCER trials

Trials by the same sponsor.

NCT07340619 — Clinical Trial Evaluating the Biological Activity of a New Drug Identified as Prifetrastat (PF-07248144), Combined With · Phase 2 · not yet recruiting
NCT07340567 — Personalizing Chemotherapy Selection After Surgery for Patients With Stage III Colorectal Cancer Using a Blood Test · Phase 3 · not yet recruiting
NCT07360834 — Study Aiming to Test Whether Non-invasive Liquid Biopsies Can Safely Reduce Invasive Surveillance Methods in Lynch Syndr · NA · not yet recruiting
NCT07106632 — Optimising Adjuvant Chemotherapy Prescription in Young Patients With Hormone-dependent Breast Cancer Using Genomic Tests · Phase 3 · not yet recruiting
NCT07294430 — Antibody-based PET Imaging and Treatment Response in Breast Cancer Treated With an Antibody-drug Conjugate. · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00227747 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by UNICANCER
Last refreshed: 17 February 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00227747.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing