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NCT Number: NCT01348217

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

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%.

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Key information

Conditions

Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Centre Georges François Leclerc

Dijon, 21000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age> or = 18 and < 75 ans
  • WHO Status 0, 1 and 2
  • Enteral or parenteral feeding (> or = 1500 KCal) planned before the start of treatment
  • Histologically proven carcinoma of the oesophagus
  • Histological Types: adenocarcinomas and epidermoid carcinomas
  • T3, N0-N1-N2-N3, M0 (TNM version 7)
  • T1-T2, N0-N1-N2-N3, M0 with a contra-indication for surgery (TNM version 7)
  • Absence of trachea-oesophageal fistula
  • Written informed consent
  • Woman under appropriate contraception
  • Patient able to understand and complete, with help if necessary, a quality of life questionnaire

Exclusion criteria

  • Evolutive heart failure or myocardial necrosis for less than 6 months
  • Myocardial infarction of more than 6 months with ischemic sequelae on myocardial scintigraphy.
  • Patient cannot absorb at least 1500kcal/j before and/or during treatment
  • Left heart failure.
  • Stage II to IV arteriopathy in the Leriche and Fontaine classification
  • Creatinine > or = 1.25x N
  • PNN < 1,5.109 /l
  • Platelets < 100. 109 /l
  • Albumin < 30g/l
  • TP < 60% without anticoagulant
  • VEMS < 1l
  • History of cancer (except baso-cellular cutaneous epithelioma or in situ epithelioma of the cervix) that has relapsed in the 5 years preceding recruitment for the trial
  • Patient already enrolled in another therapeutic trial with an experimental molecule
  • Women who are pregnant or likely to be so, or who are breastfeeding
  • People who are in custody or under guardianship
  • Impossibility to adhere to the medical follow up for the trial for geographical,social or psychiatric reasons.
  • Presence of a history of radiotherapy to the chest or upper abdomen for another tumour
  • Peripheral neuropathy > or = grade 1 (CTC v3.0)

Treatment and study plan

Conformal 3D Radiotherapy with " ENI "-type prophylactic irradiation of the lymph node

Radiation

40 Gy in 20 fractions / 5 weeks, PTV (1cm in every direction)

Boost

Radiation

Boost 10 Gy in 5 fr, PTV = +1cm.

chemotherapy: FOLFOX 4

Drug

6 treatments with 4 courses concomitant to radiotherapy (D1, D15, D29, D43) arm B or 3 courses concomitant to radiotherapy (D1, D15, D29) arm A.

Primary outcomes

  1. Evaluate the rate of acute toxicity leading to cessation or temporary interruption of treatment of more than a total of 14 days or of 7 consecutive days during the whole treatment.

    Time frame: end of phase II (january 2014)

  2. Evaluate the rate of completes endoscopic response at 3 months

    Time frame: for each patient 3 months after the end treatment

  3. Survival without locoregional relapse at 2 years (time elapsed between date of randomisation and onset of local relapse and/or lymph node involvement)

    Time frame: after the end of phase III in january 2015 (anticipated)

Secondary outcomes

  1. Evaluate adherence

    Time frame: every 3 months until the end of phase II (january 2014)

  2. Evaluate acute toxicity at 3 months

    Time frame: for each patient 3 months after the end treatment

  3. Evaluate death due to toxicity

    Time frame: each month during all the study

  4. Evaluate quality of life (QLQ-C30 [annex n° 2] + OG25 [annex n° 3])

    Time frame: after the completion of phase II (january 2014)

  5. Compare according to treatment arm :Quality of life (QLQ-C30 [annex n° 2] + OG 25 [annex n° 3])

    Time frame: after the completion of phase III (january 2015-anticpated)

  6. Compare according to treatment arm :Overall survival

    Time frame: after the completion of phase III (january 2015-anticpated)

  7. Compare according to treatment arm :Disease-free survival

    Time frame: after the completion of phase III (january 2015-anticpated)

  8. Compare according to treatment arm :Acute and late toxicity according to the CTCAE version 3.0 scale

    Time frame: after the completion of phase III (january 2015-anticpated)

  9. Compare according to treatment arm :The number of palliative interventions, the time to the first palliative intervention

    Time frame: after the completion of phase III (january 2015-anticpated)

  10. Compare according to treatment arm :The rate of dysphagia according to Atkinson's criteria

    Time frame: after the completion of phase III (january 2015-anticipated)

  11. Compare according to treatment arm :Survival without local recurrence in responders

    Time frame: after the completion of phase III (january 2015-anticipated)

  12. Compare according to treatment arm :Progression-free survival in non-responding patients

    Time frame: after the completion of phase III (january 2015-anticipated)

  13. Evaluation of the post-operative morbi-mortalities

    Time frame: after the completion of phase III (january 2015-anticipated)

    Evaluation of the post-operative morbi-mortalities (in 30 days) of the group of patients which will benefit from of a surgery of the tumoral residue.

Sponsors and collaborators

Lead sponsor

Centre Georges Francois Leclerc

Other

Collaborators

  • Federation Francophone de Cancerologie Digestive
  • National Cancer Institute, France
  • SFRO:French Society of Radiation Oncology
  • UNICANCER

Registry information

Official study title

Prodige 26: Radiochemotherapy With and Without Dose Escalation in Patients Presenting Locally Advanced or Inoperable Carcinoma of the Oesophagus

Acronym: CONCORDE

Important dates

Study start
2011
Primary completion
2011
Study completion
2018
First posted
May 5, 2011
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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