- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01348217
Radiochemotherapy With and Without Dose Escalation in Patients Presenting Locally Advanced or Inoperable Carcinoma of the Oesophagus (CONCORDE)
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%.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 2
- Fáze 3
Kontakty a umístění
Studijní místa
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Dijon, Francie, 21000
- Centre Georges François Leclerc
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Aktivní komparátor: ARM A
Conformal 3D Radiotherapy with " ENI "-type prophylactic irradiation of the lymph nodes:
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40 Gy in 20 fractions / 5 weeks, PTV (1cm in every direction)
Boost 10 Gy in 5 fr, PTV = +1cm.
Boost 26 Gy in 13 fr, PTV = +1cm.
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.
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Experimentální: ARM B
Conformal 3D Radiotherapy with " ENI "-type prophylactic irradiation of the lymph nodes:
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40 Gy in 20 fractions / 5 weeks, PTV (1cm in every direction)
Boost 10 Gy in 5 fr, PTV = +1cm.
Boost 26 Gy in 13 fr, PTV = +1cm.
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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
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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.
Časové okno: end of phase II (january 2014)
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end of phase II (january 2014)
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Evaluate the rate of completes endoscopic response at 3 months
Časové okno: for each patient 3 months after the end treatment
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for each patient 3 months after the end treatment
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Survival without locoregional relapse at 2 years (time elapsed between date of randomisation and onset of local relapse and/or lymph node involvement)
Časové okno: after the end of phase III in january 2015 (anticipated)
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after the end of phase III in january 2015 (anticipated)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Evaluate adherence
Časové okno: every 3 months until the end of phase II (january 2014)
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every 3 months until the end of phase II (january 2014)
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Evaluate acute toxicity at 3 months
Časové okno: for each patient 3 months after the end treatment
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for each patient 3 months after the end treatment
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Evaluate death due to toxicity
Časové okno: each month during all the study
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each month during all the study
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Evaluate quality of life (QLQ-C30 [annex n° 2] + OG25 [annex n° 3])
Časové okno: after the completion of phase II (january 2014)
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after the completion of phase II (january 2014)
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Compare according to treatment arm :Quality of life (QLQ-C30 [annex n° 2] + OG 25 [annex n° 3])
Časové okno: after the completion of phase III (january 2015-anticpated)
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after the completion of phase III (january 2015-anticpated)
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Compare according to treatment arm :Overall survival
Časové okno: after the completion of phase III (january 2015-anticpated)
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after the completion of phase III (january 2015-anticpated)
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Compare according to treatment arm :Disease-free survival
Časové okno: after the completion of phase III (january 2015-anticpated)
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after the completion of phase III (january 2015-anticpated)
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Compare according to treatment arm :Acute and late toxicity according to the CTCAE version 3.0 scale
Časové okno: after the completion of phase III (january 2015-anticpated)
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after the completion of phase III (january 2015-anticpated)
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Compare according to treatment arm :The number of palliative interventions, the time to the first palliative intervention
Časové okno: after the completion of phase III (january 2015-anticpated)
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after the completion of phase III (january 2015-anticpated)
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Compare according to treatment arm :The rate of dysphagia according to Atkinson's criteria
Časové okno: after the completion of phase III (january 2015-anticipated)
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after the completion of phase III (january 2015-anticipated)
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Compare according to treatment arm :Survival without local recurrence in responders
Časové okno: after the completion of phase III (january 2015-anticipated)
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after the completion of phase III (january 2015-anticipated)
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Compare according to treatment arm :Progression-free survival in non-responding patients
Časové okno: after the completion of phase III (january 2015-anticipated)
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after the completion of phase III (january 2015-anticipated)
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Evaluation of the post-operative morbi-mortalities
Časové okno: after the completion of phase III (january 2015-anticipated)
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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.
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after the completion of phase III (january 2015-anticipated)
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Gilles Créhange, MD, Centre Georges François Leclerc
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 0291-1crgi09
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