Optimisation of Response for Organ Preservation in Rectal Cancer : Neoadjuvant Chemotherapy and Radiochemotherapy vs. Radiochemotherapy
NCT ID: NCT02514278
Last Updated: 2024-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
218 participants
INTERVENTIONAL
2016-01-28
2024-06-30
Brief Summary
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The objective of the new trial is to increase the proportion of patients treated with organ preservation by optimizing tumour response. As compared to Folfiri, tritherapy Folfirinox has been shown to enhance the response rate. In patients with colorectal metastases, response rate and R0 resection were twice higher, resulting in improved survival. Folfirinox also increases response and chance of R0 resection rates in initially unresectable colorectal metastases, compared to standard or intensified bi-chemotherapy regimens. Adding two months of neoadjuvant chemotherapy (Folfirinox) before radiochemotherapy, the investigators expect to increase chance of organ preservation rate, as compared to radiochemotherapy alone.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Chemotherapy and Radiochemotherapy
Neoadjuvant chemotherapy Folfirinox, 4 cycles:
* oxaliplatin: 85 mg/m2
* irinotecan: 180 mg/m²
* folinic acid: 400 mg/m2 (DL form) or 200 mg/m2 (L form)
* 5FU: 2400 mg/m2
Radiochemotherapy : 2 to 4 weeks after chemotherapy, 5 weeks (50 Gy, 2 Gy/session; 25 fractions) + capecitabine (1600 mg/m2 daily 5 days/7)
Neoadjuvant chemotherapy Folfirinox, 4 cycles
* oxaliplatin: 85 mg/m2
* irinotecan: 180 mg/m²
* folinic acid: 400 mg/m2 (DL form) or 200 mg/m2 (L form)
* 5FU: 2400 mg/m2
50 Gy, 2 Gy/session; 25 fractions
Radiochemotherapy 5 weeks
Local excision in good responders
If local excision:
* Surveillance if ypT0-1 or ypT2Nx/cN0 (no lymph node at baseline imaging)
* Complementary rectal excision if ypT2Nx/cN1, ypT3 or R1.
Rectal excision in bad responders
Capecitabine
1600 mg/m2 daily 5 days/7
Radiochemotherapy
Radiochemotherapy: 5 weeks (50 Gy, 2 Gy/session ; 25 fractions) + capecitabine (1600 mg/m2 daily 5 days/7, excluding weekends)
50 Gy, 2 Gy/session; 25 fractions
Radiochemotherapy 5 weeks
Local excision in good responders
If local excision:
* Surveillance if ypT0-1 or ypT2Nx/cN0 (no lymph node at baseline imaging)
* Complementary rectal excision if ypT2Nx/cN1, ypT3 or R1.
Rectal excision in bad responders
Capecitabine
1600 mg/m2 daily 5 days/7
Interventions
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Neoadjuvant chemotherapy Folfirinox, 4 cycles
* oxaliplatin: 85 mg/m2
* irinotecan: 180 mg/m²
* folinic acid: 400 mg/m2 (DL form) or 200 mg/m2 (L form)
* 5FU: 2400 mg/m2
50 Gy, 2 Gy/session; 25 fractions
Radiochemotherapy 5 weeks
Local excision in good responders
If local excision:
* Surveillance if ypT0-1 or ypT2Nx/cN0 (no lymph node at baseline imaging)
* Complementary rectal excision if ypT2Nx/cN1, ypT3 or R1.
Rectal excision in bad responders
Capecitabine
1600 mg/m2 daily 5 days/7
Eligibility Criteria
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Inclusion Criteria
* cT2T3
* cN0-1 (≤ 3 positive lymph nodes or size ≤8mm)
* Tumour size ≤4 cm
* Location ≤10 cm from the anal verge
* No distant metastasis
* Patient ≥18 years
* ECOG ≤2
* Effective contraception during the study
* Patient and doctor have signed informed consent
Exclusion Criteria
* Tumour size \>4cm
* N2 (\>3 positive lymph nodes or size \>8mm)
* Tumour \> 10 cm from the anal verge
* Distant metastasis
* Chronic intestinal inflammation and/or bowel obstruction
* Contra indication for chemotherapy and/or radiotherapy
* Previous pelvic radiotherapy or chemotherapy
* Severe renal, hepatic insufficiency (serum creatinine\<30ml/min)
* Peripheral neuropathy \> grade 1
* Complete or partial Dihydropyrimidine deshydrogenase (DPD) deficiency (uracilemia ≥ 16 ng/mL)
* Concomitant treatment with millepertuis, yellow fever vaccine, phenytoin or sorivudine (or chemically equivalent)
* Pregnant or breast-feeding woman.
* Persons deprived of liberty or under guardianship
* Impossibility for compliance to follow-up
18 Years
ALL
No
Sponsors
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University Hospital, Bordeaux
OTHER
Responsible Party
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Principal Investigators
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Christophe LAURENT, Prof.
Role: PRINCIPAL_INVESTIGATOR
University Hospital Bordeaux, France
Locations
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Service de Chirurgie Digestive, CHU Amiens Picardie
Amiens, , France
Service de Chirurgie Digestive, CHU de Besançon
Besançon, , France
Service de Chirurgie Digestive, Hôpital Haut-Lévêque - CHU de Bordeaux
Bordeaux, , France
Service de Chirurgie Digestive, Institut Bergonié
Bordeaux, , France
Service de Chirurgie Digestive, CHU Estaing - CHRU Clermont Ferrand
Clermont-Ferrand, , France
Service de Chirurgie Digestive, Hôpital Beaujon - APHP
Clichy, , France
Service de Chirurgie Digestive, Centre Georges François Leclerc - Dijon
Dijon, , France
Service de Chirurgie Digestive, Hôpital Albert Michallon - CHU de Grenoble
La Tronche, , France
Service de Chirurgie Digestive, Centre Oscar Lambret - Lille
Lille, , France
Service de Chirurgie Digestive, Centre Léon Bérard - Lyon
Lyon, , France
Service de Chirurgie Digestive, Hôpital Lyon Sud - CHU Lyon
Lyon, , France
Service de Chirurgie Digestive, CHU de la Timone - Marseille
Marseille, , France
Service de Chirurgie Digestive, Institut Paoli Calmette - Marseille
Marseille, , France
Service de Chirurgie Digestives, Hôpital Européen de Marseille
Marseille, , France
Service de Chirurgie Digestive, Institut du Cancer de Montpellier
Montpellier, , France
Service d'Oncologie et Radiothérapie, Centre Azuréen de Cancérologie
Mougins, , France
Service de Chirurgie Digestive,Institut de Cancérologie de Lorraine
Nancy, , France
Service de Chirurgie Digestive, Hôtel Dieu - CHU de Nantes
Nantes, , France
Service de Chirurgie Digestive, CHU Carémeau - Nîmes
Nîmes, , France
GH Paris Saint Joseph
Paris, , France
Service de Chirurgie Digestive et Oncologique, Hôpital Bicêtre - APHP
Paris, , France
Service de Chirurgie Digestive, Hôpital les Diaconnesses
Paris, , France
Service de Chirurgie Digestive, Hôpital Saint-Antoine - APHP
Paris, , France
Service de Chirurgie Digestive, Hôpital Saint-Louis - APHP Paris
Paris, , France
Service de Chirurgie Digestive, Hôpital Pontchaillou - CHU Rennes
Rennes, , France
Service de Chirurgie Digestive, Hôpital Charles Nicolle - CHU de Rouen
Rouen, , France
Service de Chirurgie Digestive, Hôpital Purpan - CHU de Toulouse
Toulouse, , France
Service de chirurgie digestive, CHRU de Nancy -Hôpital de Brabois
Vandœuvre-lès-Nancy, , France
Département de chirurgie digestive, Institut Gustave Roussy
Villejuif, , France
Countries
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Other Identifiers
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CHUBX 2014/33
Identifier Type: -
Identifier Source: org_study_id
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