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Esophageal CancerPhase 2/3CONCORDENCT01348217

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

A Phase 2/3 study testing Conformal 3D Radiotherapy with " ENI "-type prophylactic irradiation of the lymph node, Boost and chemotherapy: FOLFOX 4 in people with Esophageal Cancer, run by Centre Georges Francois Leclerc at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Cancer
What is being tested?
Conformal 3D Radiotherapy with " ENI "-type prophylactic irradiation of the lymph node, Boost and chemotherapy: FOLFOX 4
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
196 participants
Where
1 siteFrance
Study dates
6 May 2011to 17 Dec 2018
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

France1 site

  • Centre Georges François Leclerc

    Dijon, 21000

Other trials in France

About this study

Official title: Prodige 26: 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%.

Being tested
Conformal 3D Radiotherapy with " ENI "-type prophylactic irradiation of the lymph node, Boost, chemotherapy: FOLFOX 4
Keywords
unoperated cancers, oesophagus, radiochemotherapy, with and without increased doses
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

  • BoostRadiation

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

  • BoostRadiation

    Boost 26 Gy in 13 fr, PTV = +1cm.

  • chemotherapy: FOLFOX 4Drug

    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.

Study groups in NCT01348217
Study groupRoleWhat they receive
ARM AActive comparatorConformal 3D Radiotherapy with " ENI "-type prophylactic irradiation of the lymph nodes: 1. Radiotherapy 40 Gy, in 20 fractions / 4 weeks: PTV (1cm in every direction) 2. Boost 10 Gy in 5 fr: PTV = +1cm. 3. Chemotherapy FOLFOX 4: 6 treatments in 3 courses concomitant to the radiotherapy (D1, D15, D29)
Receives: Radiation: Conformal 3D Radiotherapy with " ENI "-type prophylactic irradiation of the lymph node; Radiation: Boost; Drug: chemotherapy: FOLFOX 4
ARM BExperimentalConformal 3D Radiotherapy with " ENI "-type prophylactic irradiation of the lymph nodes: 1. 40 Gy in 20 fractions / 4 weeks, PTV (1cm in every direction) 2. Boost 26 Gy in 13 fr: PTV = +1cm. 3. Chemotherapy: FOLFOX 4: 6 treatments with 4 courses concomitant to radiotherapy (D1, D15, D29, D43).
Receives: Radiation: Conformal 3D Radiotherapy with " ENI "-type prophylactic irradiation of the lymph node; Radiation: Boost; Drug: chemotherapy: FOLFOX 4

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: end of phase II (january 2014)

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

    Measured: 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)

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

Secondary outcomes (13)

  1. Evaluate adherence

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

  2. Evaluate acute toxicity at 3 months

    Measured: for each patient 3 months after the end treatment

  3. Evaluate death due to toxicity

    Measured: each month during all the study

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

    Measured: 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])

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

  6. Compare according to treatment arm :Overall survival

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

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

    Measured: 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

    Measured: 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

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

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

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

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

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

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

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

  13. Evaluation of the post-operative morbi-mortalities

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2011 (estimated)
  2. Study start6 May 2011
  3. Primary completion7 Jun 2011
  4. Study completion17 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
196 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01348217
Sponsor's protocol ID
0291-1crgi09
Acronym
CONCORDE
Status last verified
Jan 2020
First submitted
29 Apr 2011
Last updated
27 Jan 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Bednarek C, Crehange G, Quivrin M, Cueff A, Vulquin N, Chevalier C, Cerda T, Petegnief Y, Mazoyer F, Maingon P, Bosset JF, Servagi Vernat S. Mapping of failures after radiochemotherapy in patients with non-metastatic esophageal cancer: A posteriori analysis of the dose distribution in the sites of loco-regional relapse. Radiother Oncol. 2015 Aug;116(2):252-6. doi: 10.1016/j.radonc.2015.07.019. Epub 2015 Jul 27.

    PubMed 26228970

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Conformal 3D Radiotherapy with " ENI "-type prophylactic irradiation of the lymph node, Boost and chemotherapy: FOLFOX 4 in people with Esophageal Cancer, run by Centre Georges Francois Leclerc at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01348217, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.

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