Cancer of the RectumPhase 3NéofirinoxNCT01804790
Efficacy of Neoadjuvant Folfirinox Regimen in Patients With Resectable Locally Advanced Rectal Cancer
A Phase 3 study testing mFolfirinox, Radiotherapy 50 Gy and Capecitabine in people with Cancer of the Rectum, run by UNICANCER at 36 sites in France.
Trial summary
National, multi-center, open-label,randomized, 2-arm phase III superiority trial, comparing neoadjuvant chemotherapy (CT) with mFolfirinox followed by preoperative chemoradiotherapy (CRT), versus preoperative CRT in patients with locally advanced rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cancer of the Rectum
- What is being tested?
- mFolfirinox, Radiotherapy 50 Gy and Capecitabine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 461 participants
- Where
- 36 sitesFrance
- Study dates
- Jan 2012to 1 Jul 2023
- Phase
- Phase 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
- Histologically proven rectal adenocarcinoma
- Stages cT3 with risk of local recurrence or cT4, M0 and for which a multidisciplinary meeting recommend preoperative CRT
- Resectable tumor, or considered as potentially resectable after CRT
- No distant metastases
- Patient eligible for surgery
- Patient aged from 18 to 75 years
Show all 15Show fewer
- World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status 0/2.
- No heart failure or coronary heart disease symptoms (even controlled).
- No peripheral neuropathy > grade 1
- No prior radiotherapy of the pelvis for any reason and no previous CT
- No major comorbidity that may preclude the delivery of treatment and no active infection (HIV or chronic hepatitis B or C).
- Adequate contraception in fertile patients.
- Adequate hematologic function
- Adequate hepatic function
- Signed written informed consent
Who cannot join
- Metastatic disease
- Unresectable rectal cancer, including prostatic involvement or extension to pelvic floor muscles
- Contraindication to 5-FU, or to oxaliplatin or to irinotecan, including Gilbert disease or genotype UGT1A1
- Medical history of chronic diarrhea or inflammatory disease of the colon or rectum
- Medical history of angina pectoris or myocardial infarction
- Progressive active infection or any other severe medical condition that could jeopardize treatment administration
Show all 11Show fewer
- Other concomitant cancer, or medical history of cancer other than treated in situ cervical carcinoma or basocellular carcinoma or spinocellular carcinoma
- Patient included in another clinical trial testing an investigational agent.
- Pregnant or breast-feeding woman.
- Persons deprived of liberty or under guardianship or incapable of giving consent
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule.
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
France36 sites
Centre hospitalier Universitaire d'Amiens
Amiens
ICO - Site Paul Papin
Angers
Centre hospitalier d'Auxerre
Auxerre
Centre Hospitalier de Beauvais
Beauvais
Institut de Cancérologie de Franche Comté
Besançon
Centre Hospitalier de Blois
Blois
Hopital Avicenne
Bobigny
Clinique Tivoli
Bordeaux
Hopital Saint Andre
Bordeaux
Institut Bergonie
Bordeaux
Centre Francois Baclesse
Caen
Chd de La Roche Sur Yon - Les Oudairies
La Roche-sur-Yon
Centre Bourgogne
Lille
Centre Oscar Lambret
Lille
Centre Léon Bérard
Lyon
Hopital Prive Jean Mermoz
Lyon
Ap Hm - Hopital de La Timone - Adultes
Marseille
Institut de Cancérologie de Franche Comté
Montbéliard
Centre Azuréen de cancérologie
Mougins
Hopital Emile Muller
Mulhouse
centre Alexis Vautrin
Nancy
Polyclinique de Gentilly
Nancy
Centre Antoine Lacassagne
Nice
Groupe Hospitalier La Pitie-Salpetriere
Paris
Institut Mutualiste Montsouris
Paris
Hopital Haut Leveque
Pessac
Centre Hospitalier Regional D'Annecy
Pringy
Hopital Robert Debre
Reims
Institut Jean Godinot
Reims
Clinique Armoricaine de Radiologie
Saint-Brieuc
Hopital Saint Gregoire
Saint-Grégoire
ICO - Site René Gauducheau
Saint-Herblain
Clinique Mutualiste de L'Estuaire
Saint-Nazaire
Centre Hospitalier de la Réunion - Site du GHSR
Saint-Pierre
Centre Paul Strauss
Strasbourg
Gustave Roussy
Villejuif
About this study
Official title: Randomized Phase III Study Comparing Preoperative Chemoradiotherapy Alone Versus Neoadjuvant Chemotherapy With Folfirinox Regimen Followed by Preoperative Chemoradiotherapy for Patients With Resectable Locally Advanced Rectal Cancer
National, multi-center, open-label,randomized, 2-arm phase III superiority trial, comparing neoadjuvant chemotherapy (CT) with mFolfirinox followed by preoperative chemoradiotherapy (CRT), versus preoperative CRT in patients with locally advanced rectal cancer.
Read the detailed description
Methodology This is a biomedical research, national, multicenter, open-label randomized, 2-arm phase III superiority trial, comparing neoadjuvant CT with mFolfirinox then preoperative CRT, versus immediate preoperative CRT, in patients with locally advanced rectal cancer Randomized Phase III study with stopping rules Stratification : center, gender, tumor location in the rectum (<6 cm from anal verge versus ≥6 cm), initial stage (cT3 vs cT4, and cN0 vs cN+)
- Conditions
- Cancer of the Rectum
- Being tested
- mFolfirinox, Radiotherapy 50 Gy, Capecitabine, TME surgery, mFolfox6 or capecitabine
- Keywords
- rectum, cancer, locally advanced
- Medical subject headings
- Rectal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mFolfirinoxDrug
Investigational arm: Neoadjuvant chemotherapy mFolfirinox, 4 cycles: oxaliplatin: 85 mg/m² in 2 hours at D1 irinotecan: 180 mg/m² in 90 min at D1 folinic acid: 400 mg/m² simultaneously in 2 hours at D1 during the irinotecan infusion 5-FU: 2400 mg/m² continuous infusion during 48 hours (1200 mg/m² at D1 and D2), every 14 days during 2 months (4 cycles), then CRT (50 Gy (2 Gy/session, 25 fractions) + capecitabine 800 mg/m² twice a day 5 days/7), then surgery with TME 6-8 weeks after chemoradiation, and 4 months of adjuvant CT depending on the center's choice.
Radiotherapy 50 GyRadiation
5 radiations per week of 2 Gy for 5 weeks
CapecitabineDrug
1600 mg/m² (800 mg/m² twice daily) for 5 weeks
TME surgeryProcedure or surgery
mFolfox6 or capecitabineDrug
oxaliplatine 85 mg/m² (day 1 of cycle; perfusion in 2h), folinic acid 400 mg/m² (day 1 of cycle perfusion in 2h), 5-FU (bolus 400 mg/m² in 10 min and 2400 mg/m² perfusion continuous 46h). Arm A - 12 cycles ; Arm B - 6 cycles OR Capecitabine 2500 mg/m²/day (Each cycle consists of 1250 mg/m² twice daily for D1-14 then pause therapeutic from D15-21). Arm A - 8 cycles; Arm B 4 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Arm A : Radiotherapy + capecitabine | Active comparator | Chemoradiotherapy 5 weeks (50 Grays (Gy), 2 Gy/session ; 25 fractions) + capecitabine 800 mg/m² twice daily 5 days/7, excluding weekends), then 6-8 weeks after chemoradiation, surgery with total mesorectal excision (TME), followed by adjuvant chemotherapy for 6 months, either mFolfox6 or capecitabine, depending on the center's choice. Receives: Radiation: Radiotherapy 50 Gy; Drug: Capecitabine; Procedure: TME surgery; Drug: mFolfox6 or capecitabine |
| Arm B : Chemotherapy then radiochemotherapy | Experimental | Drug: Chemotherapy mFolfirinox
Investigational arm: Neoadjuvant CT mFolfirinox, 6 cycles (ca. 3 months; each cycle = 2 weeks):
oxaliplatin: 85 mg/m² in 2 hours at D1 irinotecan: 180 mg/m² in 90 min at D1 folinic acid: 400 mg/m² simultaneously in 2 hours at D1 during the irinotecan infusion 5-fluorouracil (5-FU): 2400 mg/m² continuous infusion during 48 hours (1200 mg/m² at D1 and D2), every 14 days during 2 months (4 cycles).
Then followed by 5 weeks of chemoradiotherapy 50 Gy (2 Gy/session, 5 sessions per week) + capecitabine 800 mg/m² twice daily 5 days/7), then surgery with TME 6-8 weeks after chemoradiation, followed by 3 months of adjuvant chemotherapy, either mFolfox6 or capecitabine depending on the center's choice. Receives: Drug: mFolfirinox; Radiation: Radiotherapy 50 Gy; Drug: Capecitabine; Procedure: TME surgery; Drug: mFolfox6 or capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-free survival
To compare the 3-year disease-free survival between the investigational arm and the control arm.
Measured: 3 years
Secondary outcomes (1)
Overall survival
Overall survival will be defined as the time from randomisation to the time of occurrence of the first death regardless to its cause. Patients alive at the time of analysis will be censored at the date of the last follow up.
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2013 (estimated)
- Study startJan 2012
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer of the RectumStudies of the same condition, open and under way.
- More trials run by UNICANCERThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 461 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry CONROY, PROF, Principal investigator, centre Alexis Vautrin les Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01804790
- Sponsor's protocol ID
- PRODIGE 23 - UCGI 23
- Other IDs
- 2011-004406-25
- Acronym
- Néofirinox
- Status last verified
- Jun 2025
- First submitted
- 1 Mar 2013
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.
Publications
Conroy T, Bosset JF, Etienne PL, Rio E, Francois E, Mesgouez-Nebout N, Vendrely V, Artignan X, Bouche O, Gargot D, Boige V, Bonichon-Lamichhane N, Louvet C, Morand C, de la Fouchardiere C, Lamfichekh N, Juzyna B, Jouffroy-Zeller C, Rullier E, Marchal F, Gourgou S, Castan F, Borg C; Unicancer Gastrointestinal Group and Partenariat de Recherche en Oncologie Digestive (PRODIGE) Group. Neoadjuvant chemotherapy with FOLFIRINOX and preoperative chemoradiotherapy for patients with locally advanced rectal cancer (UNICANCER-PRODIGE 23): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2021 May;22(5):702-715. doi: 10.1016/S1470-2045(21)00079-6. Epub 2021 Apr 13.
PubMed 33862000
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase III Study Comparing Preoperative Chemoradiotherapy Alone Versus Neoadjuvant Chemotherapy With Folfirinox Regimen Followed by Preoperative Chemoradiotherapy for Patients With Resectable Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT01804790
- Acronym / sponsor ID
- Néofirinox / PRODIGE 23 - UCGI 23
- Conditions
- Cancer of the Rectum
- Keywords
- rectum, cancer, locally advanced
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 461 participants (actual)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 5 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
National, multi-center, open-label,randomized, 2-arm phase III superiority trial, comparing neoadjuvant chemotherapy (CT) with mFolfirinox followed by preoperative chemoradiotherapy (CRT), versus preoperative CRT in patients with locally advanced rectal cancer.
Detailed description
Methodology This is a biomedical research, national, multicenter, open-label randomized, 2-arm phase III superiority trial, comparing neoadjuvant CT with mFolfirinox then preoperative CRT, versus immediate preoperative CRT, in patients with locally advanced rectal cancer Randomized Phase III study with stopping rules Stratification : center, gender, tumor location in the rectum (<6 cm from anal verge versus ≥6 cm), initial stage (cT3 vs cT4, and cN0 vs cN+)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A : Radiotherapy + capecitabine | Active comparator | Radiation: Radiotherapy 50 Gy, Drug: Capecitabine, Procedure: TME surgery, Drug: mFolfox6 or capecitabineChemoradiotherapy 5 weeks (50 Grays (Gy), 2 Gy/session ; 25 fractions) + capecitabine 800 mg/m² twice daily 5 days/7, excluding weekends), then 6-8 weeks after chemoradiation, surgery with total mesorectal excision (TME), followed by adjuvant chemotherapy for 6 months, either mFolfox6 or capecitabine, depending on the center's choice. |
| Arm B : Chemotherapy then radiochemotherapy | Experimental | Drug: mFolfirinox, Radiation: Radiotherapy 50 Gy, Drug: Capecitabine, Procedure: TME surgery, Drug: mFolfox6 or capecitabineDrug: Chemotherapy mFolfirinox Investigational arm: Neoadjuvant CT mFolfirinox, 6 cycles (ca. 3 months; each cycle = 2 weeks): oxaliplatin: 85 mg/m² in 2 hours at D1 irinotecan: 180 mg/m² in 90 min at D1 folinic acid: 400 mg/m² simultaneously in 2 hours at D1 during the irinotecan infusion 5-fluorouracil (5-FU): 2400 mg/m² continuous infusion during 48 hours (1200 mg/m² at D1 and D2), every 14 days during 2 months (4 cycles). Then followed by 5 weeks of chemoradiotherapy 50 Gy (2 Gy/session, 5 sessions per week) + capecitabine 800 mg/m² twice daily 5 days/7), then surgery with TME 6-8 weeks after chemoradiation, followed by 3 months of adjuvant chemotherapy, either mFolfox6 or capecitabine depending on the center's choice. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically proven rectal adenocarcinoma
- Stages cT3 with risk of local recurrence or cT4, M0 and for which a multidisciplinary meeting recommend preoperative CRT
- Resectable tumor, or considered as potentially resectable after CRT
- No distant metastases
- Patient eligible for surgery
Key exclusion criteria (11 listed)
- Metastatic disease
- Unresectable rectal cancer, including prostatic involvement or extension to pelvic floor muscles
- Contraindication to 5-FU, or to oxaliplatin or to irinotecan, including Gilbert disease or genotype UGT1A1
- Medical history of chronic diarrhea or inflammatory disease of the colon or rectum
- Medical history of angina pectoris or myocardial infarction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mFolfirinoxInvestigational arm: Neoadjuvant chemotherapy mFolfirinox, 4 cycles: oxaliplatin: 85 mg/m² in 2 hours at D1 irinotecan: 180 mg/m² in 90 min at D1 folinic acid: 400 mg/m² simultaneously in 2 hours at D1 during the irinotecan infusion 5-FU: 2400 mg/m² continuous infusion during 48 hours (1200 mg/m² at D1 and D2), every 14 days during 2 months (4 cycles), then CRT (50 Gy (2 Gy/session, 25 fractions) + capecitabine 800 mg/m² twice a day 5 days/7), then surgery with TME 6-8 weeks after chemoradiation, and 4 months of adjuvant CT depending on the center's choice. | Drug | Arm B : Chemotherapy then radiochemotherapy |
| Radiotherapy 50 Gy5 radiations per week of 2 Gy for 5 weeks | Radiation | Arm A : Radiotherapy + capecitabine, Arm B : Chemotherapy then radiochemotherapy |
| Capecitabine1600 mg/m² (800 mg/m² twice daily) for 5 weeks | Drug | Arm A : Radiotherapy + capecitabine, Arm B : Chemotherapy then radiochemotherapy |
| TME surgery | Procedure or surgery | Arm A : Radiotherapy + capecitabine, Arm B : Chemotherapy then radiochemotherapy |
| mFolfox6 or capecitabineoxaliplatine 85 mg/m² (day 1 of cycle; perfusion in 2h), folinic acid 400 mg/m² (day 1 of cycle perfusion in 2h), 5-FU (bolus 400 mg/m² in 10 min and 2400 mg/m² perfusion continuous 46h). Arm A - 12 cycles ; Arm B - 6 cycles OR Capecitabine 2500 mg/m²/day (Each cycle consists of 1250 mg/m² twice daily for D1-14 then pause therapeutic from D15-21). Arm A - 8 cycles; Arm B 4 cycles. | Drug | Arm A : Radiotherapy + capecitabine, Arm B : Chemotherapy then radiochemotherapy |
Primary outcome
disease-free survival
Time frame: 3 years
To compare the 3-year disease-free survival between the investigational arm and the control arm.
1 secondary outcome
Overall survival
Time frame: 7 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Results publication: PubMed 33862000Conroy T, Bosset JF, Etienne PL, Rio E, Francois E, Mesgouez-Nebout N, Vendrely V, Artignan X, Bouche O, Gargot D, Boige V, Bonichon-Lamichhane N, Louvet C, Morand C, de la Fouchardiere C, Lamfichekh N, Juzyna B, Jouffroy-Zeller C, Rullier E, Marchal F, Gourgou S, Castan F, Borg C; Unicancer Gastrointestinal Group and Partenariat de Recherche en Oncologie Digestive (PRODIGE) Group. Neoadjuvant chemotherapy with FOLFIRINOX and preoperative chemoradiotherapy for patients with locally advanced rectal cancer (UNICANCER-PRODIGE 23): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2021 May;22(5):702-715. doi: 10.1016/S1470-2045(21)00079-6. Epub 2021 Apr 13.
- Lancet Oncology 2021 Apr 13: publication of resultsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thierry CONROY, PROF principal investigator
centre Alexis Vautrin les Nancy
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing mFolfirinox, Radiotherapy 50 Gy and Capecitabine in people with Cancer of the Rectum, run by UNICANCER at 36 sites 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 15 inclusion and 11 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 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites 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 phase mean?
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?
disease-free survival (time frame: 3 years). 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 NCT01804790, 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 12 Jun 2025.