NCT01348217: CONCORDE

Radiochemotherapy With and Without Dose Escalation in Patients Presenting Locally Advanced or Inoperable Carcinoma of the Oesophagus

Completed Phase 2, PHASE3 Last updated 27 January 2020

What this trial tests

Phase 2, PHASE3 trial testing Conformal 3D Radiotherapy with " ENI "-type prophylactic irradiation of the lymph node in Esophageal Cancer in 196 participants. Completed in 17 December 2018.

Timeline

6 May 2011

Primary endpoint
7 June 2011

17 December 2018

Quick facts

Lead sponsor	Centre Georges Francois Leclerc
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	196
Start date	6 May 2011
Primary completion	7 June 2011
Estimated completion	17 December 2018
Sites	1 location across France

Drugs / interventions tested

• Conformal 3D Radiotherapy with " ENI "-type prophylactic irradiation of the lymph node
• Boost
• Boost
• chemotherapy: FOLFOX 4 — full drug profile →

Conditions studied

• Esophageal Cancer — all drugs for Esophageal Cancer →

Sponsor

Centre Georges Francois Leclerc — full company profile →

Who can join

Adults 18 to 75, any sex, with Esophageal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Exclusive concomitant radiochemotherapy (RCT) at a dose of 50 Gy delivered over 5 weeks, according to the RTOG 85-01 protocol, has led to improved 5-year survival in 25% of patients, whereas no patients survived for 5 years using radiotherapy alone for patients with esophageal cancer. Surgery, even when combined with preoperative RCT, also gives disappointing results for locally advanced tumors, which casts serious doubts on the usefulness of preoperative radiotherapy. By varying the fractionation schedule, the length of treatment or the radiotherapy volumes, it has become possible to obtain levels of loco-regional relapse of around 35 to 45%. After reviewing the results for loco-regional relapse according to the dose of radiation and the recommended radiotherapy volumes, we aimed to investigate why increasing the dose of radiation has no impact in esophageal cancers. Although INT-0123 phase III trial showed no benefit of dose escalation in esophageal cancer, some issues remain unclear as most of the patients who died in the experimental arm were treated above 50Gy. Moreover, only the tumor was treated up to 64Gy while involved nodes were not considered for dose escalation in this trial. In the RTOG 85-01phase III trial, an elective nodal irradiation from subclavicular fossa up to the esophagogastric junction was performed with a 2D technique, delivering 30Gy which could be considered as not appropriate.

In this randomized phase II/III trial, we aim to test an exclusive concomitant chemoradiotherapy for patients with non resectable esophageal cancer with a dose escalation up to 66Gy on the primary tumor as well as the involved nodes using a 3D conformal technique combined with a 40 Gy elective nodal irradiation on lymph node stations (as defined by the RTOG) with a risk of microscopic involvement ≥ 20%.

Publications & conference data

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

1. Improving Outcomes for Esophageal Cancer using Proton Beam Therapy.
   Chuong MD, Hallemeier CL, Jabbour SK, Yu J, et al · · 2016 · cited 62× · PMID 27084662 · DOI 10.1016/j.ijrobp.2015.11.043
2. Current status and perspectives of esophageal cancer: a comprehensive review.
   Jiang W, Zhang B, Xu J, Xue L, et al · · 2025 · cited 28× · PMID 39723635 · DOI 10.1002/cac2.12645
3. New and emerging combination therapies for esophageal cancer.
   Wiedmann MW, Mössner J. · · 2013 · cited 21× · PMID 23869177 · DOI 10.2147/cmar.s32199
4. Long-term results of definitive chemoradiotherapy for unresectable locally advanced esophageal squamous cell carcinoma.
   Ochi M, Murakami Y, Nishibuchi I, Kubo K, et al · · 2021 · cited 15× · PMID 33392619 · DOI 10.1093/jrr/rraa110
5. Simultaneous integrated boost concepts in definitive radiation therapy for esophageal cancer: outcomes and toxicity.
   Ristau J, Thiel M, Katayama S, Schlampp I, et al · · 2021 · cited 13× · PMID 33522923 · DOI 10.1186/s13014-021-01749-x
6. What is the optimal radiation dose for non-operable esophageal cancer? Dissecting the evidence in a meta-analysis.
   Chen Y, Zhu HP, Wang T, Sun CJ, et al · · 2017 · cited 13× · PMID 29179502 · DOI 10.18632/oncotarget.18760
7. Modern Management of Esophageal Cancer: Radio-Oncology in Neoadjuvancy, Adjuvancy and Palliation.
   Cellini F, Manfrida S, Casà C, Romano A, et al · · 2022 · cited 12× · PMID 35053594 · DOI 10.3390/cancers14020431
8. Clinical Prognostic Factors for Patients With Esophageal Cancer Treated With Definitive Chemoradiotherapy.
   Favareto SL, Sousa CF, Pinto PJ, Ramos H, et al · · 2021 · cited 5× · PMID 34820218 · DOI 10.7759/cureus.18894