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Rectal CancerPhase 3GRECCAR12NCT02514278

Optimisation of Response for Organ Preservation in Rectal Cancer : Neoadjuvant Chemotherapy and Radiochemotherapy vs. Radiochemotherapy

A Phase 3 study testing Neoadjuvant chemotherapy Folfirinox, 4 cycles, 50 Gy, 2 Gy/session; 25 fractions and Local excision in good responders in people with Rectal Cancer, run by University Hospital, Bordeaux at 29 sites 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

Standard treatment of rectal cancer is rectal excision with neoadjuvant radiochemotherapy. A new concept suggests organ preservation as an alternative to rectal excision in good responders after neoadjuvant radiochemotherapy to decrease surgical morbidity and increase quality of life. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rectal Cancer
What is being tested?
Neoadjuvant chemotherapy Folfirinox, 4 cycles, 50 Gy, 2 Gy/session; 25 fractions and Local excision in good responders
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
218 participants
Where
29 sitesFrance
Study dates
28 Jan 2016to 30 Jun 2024
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Rectal adenocarcinoma
  • cT2T3
  • cN0-1 (≤ 3 positive lymph nodes or size ≤8mm)
  • Tumour size ≤4 cm
  • Location ≤10 cm from the anal verge
  • No distant metastasis
Show all 10Show fewer
  • Patient ≥18 years
  • ECOG ≤2
  • Effective contraception during the study
  • Patient and doctor have signed informed consent

Who cannot join

  • T1 or T4
  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

France29 sites

  • Service de Chirurgie Digestive, CHU Amiens Picardie

    Amiens

  • Service de Chirurgie Digestive, CHU de Besançon

    Besançon

  • Service de Chirurgie Digestive, Hôpital Haut-Lévêque - CHU de Bordeaux

    Bordeaux

  • Service de Chirurgie Digestive, Institut Bergonié

    Bordeaux

  • Service de Chirurgie Digestive, CHU Estaing - CHRU Clermont Ferrand

    Clermont-Ferrand

  • Service de Chirurgie Digestive, Hôpital Beaujon - APHP

    Clichy

  • Service de Chirurgie Digestive, Centre Georges François Leclerc - Dijon

    Dijon

  • Service de Chirurgie Digestive, Hôpital Albert Michallon - CHU de Grenoble

    La Tronche

  • Service de Chirurgie Digestive, Centre Oscar Lambret - Lille

    Lille

  • Service de Chirurgie Digestive, Centre Léon Bérard - Lyon

    Lyon

  • Service de Chirurgie Digestive, Hôpital Lyon Sud - CHU Lyon

    Lyon

  • Service de Chirurgie Digestive, CHU de la Timone - Marseille

    Marseille

  • Service de Chirurgie Digestive, Institut Paoli Calmette - Marseille

    Marseille

  • Service de Chirurgie Digestives, Hôpital Européen de Marseille

    Marseille

  • Service de Chirurgie Digestive, Institut du Cancer de Montpellier

    Montpellier

  • Service d'Oncologie et Radiothérapie, Centre Azuréen de Cancérologie

    Mougins

  • Service de Chirurgie Digestive,Institut de Cancérologie de Lorraine

    Nancy

  • Service de Chirurgie Digestive, Hôtel Dieu - CHU de Nantes

    Nantes

  • Service de Chirurgie Digestive, CHU Carémeau - Nîmes

    Nîmes

  • GH Paris Saint Joseph

    Paris

  • Service de Chirurgie Digestive et Oncologique, Hôpital Bicêtre - APHP

    Paris

  • Service de Chirurgie Digestive, Hôpital les Diaconnesses

    Paris

  • Service de Chirurgie Digestive, Hôpital Saint-Antoine - APHP

    Paris

  • Service de Chirurgie Digestive, Hôpital Saint-Louis - APHP Paris

    Paris

  • Service de Chirurgie Digestive, Hôpital Pontchaillou - CHU Rennes

    Rennes

  • Service de Chirurgie Digestive, Hôpital Charles Nicolle - CHU de Rouen

    Rouen

  • Service de Chirurgie Digestive, Hôpital Purpan - CHU de Toulouse

    Toulouse

  • Service de chirurgie digestive, CHRU de Nancy -Hôpital de Brabois

    Vandœuvre-lès-Nancy

  • Département de chirurgie digestive, Institut Gustave Roussy

    Villejuif

Other trials in France

About this study

Standard treatment of rectal cancer is rectal excision with neoadjuvant radiochemotherapy. A new concept suggests organ preservation as an alternative to rectal excision in good responders after neoadjuvant radiochemotherapy to decrease surgical morbidity and increase quality of life. The rational is the fact that 15% of patients have sterilized tumours after radiochemotherapy for T3T4 rectal cancer. The French GRECCAR 2 trial is the first phase III trial investigating this strategy: patients with T2T3 low rectal carcinomas (size ≤4 cm) received 50 Gy with capecitabine and good clinical responders (≤2 cm) were randomized between local and rectal excision. The main findings were: the rate of complete pathologic response was higher after radiochemotherapy for small T2T3 than for T3T4 tumours (40% vs 15% ypT0) and good pathologic responders (ypT0-1) were associated with zero positive mesorectal nodes.

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.

Conditions
Rectal Cancer
Being tested
Neoadjuvant chemotherapy Folfirinox, 4 cycles, 50 Gy, 2 Gy/session; 25 fractions, Local excision in good responders, Rectal excision in bad responders, Capecitabine
Keywords
Organ preservation, Local excision, Radiochemotherapy, Neoadjuvant chemotherapy, Folfirinox, Tumour response
Medical subject headings
Rectal Neoplasms

What participants receive

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

  • Neoadjuvant chemotherapy Folfirinox, 4 cyclesDrug

    • 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 fractionsRadiation

    Radiochemotherapy 5 weeks

  • Local excision in good respondersProcedure or surgery

    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 respondersProcedure or surgery

  • CapecitabineDrug

    1600 mg/m2 daily 5 days/7

Study groups in NCT02514278
Study groupRoleWhat they receive
Chemotherapy and RadiochemotherapyExperimentalNeoadjuvant 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)
Receives: Drug: Neoadjuvant chemotherapy Folfirinox, 4 cycles; Radiation: 50 Gy, 2 Gy/session; 25 fractions; Procedure: Local excision in good responders; Procedure: Rectal excision in bad responders; Drug: Capecitabine
RadiochemotherapyActive comparatorRadiochemotherapy: 5 weeks (50 Gy, 2 Gy/session ; 25 fractions) + capecitabine (1600 mg/m2 daily 5 days/7, excluding weekends)
Receives: Radiation: 50 Gy, 2 Gy/session; 25 fractions; Procedure: Local excision in good responders; Procedure: Rectal excision in bad responders; Drug: Capecitabine

What is being measured

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

  1. Rate of organ preservation and absence of stoma

    Number of patients with organ preservation and absence of stoma at 1 year after surgery

    Measured: 1 year after surgery

Secondary outcomes (13)

  1. Compliance to treatment

    Number of patients receiving full neoadjuvent treatment and the allocated surgery

    Measured: From beginning of neoadjuvant treatment until surgery, expected average 20 weeks after neoadjuvant treatment

  2. Tolerance to treatment

    Number of patients with adverse events

    Measured: From beginning of neoadjuvant treatment until 1 year after surgery

  3. Rate of clinical complete response

    To determine the rate of grade 1 : no tumor at digital examination

    Measured: At 8 weeks after neoadjuvant treatment

  4. Rate of radiological response

    To determine the rate of tumor ≤ 2 cm with TRG1-3 at MRI

    Measured: At 8 weeks after neoadjuvant treatment

  5. Rate of complete pathologic response

    To determine the rate of ypT0

    Measured: At surgery, expected average 10 weeks after neoadjuvant treatment

  6. Correlation between radiological and clinical response

    To analyse the correlation between radiological response ( tumor ≤ 2 cm with TRG1-3 at MRI) and clinical response (grade 1)

    Measured: Between 8 to 10 weeks after neoadjuvant treatment

  7. Correlation between radiological (radiomic analysis) and pathologic response

    To analyse the correlation between radiological response ( tumor ≤ 2 cm with TRG1-3 at MRI) and pathological response (ypT0)

    Measured: Between 8 to 10 weeks after neoadjuvant treatment

  8. Rate of curative surgery

    To determine the rate of R0 resection

    Measured: At surgery, expected average 10 weeks after neoadjuvant treatment

  9. Surgical morbidity

    To analyse the cumulative Clavien-Dindo at 1 year

    Measured: From surgery until 1 year of follow-up

  10. Quality of life

    To examine score of questionnaires : QLQ CR-30, QLQ CR-29

    Measured: From randomization until 1 year after surgery

  11. Local recurrence

    To determine the rate of local recurrence at 3 years

    Measured: From surgery until 3 years of follow-up

  12. Overall survival

    To determine the rate of overall survival at 3 years

    Measured: From surgery until 3 years of follow-up

  13. Disease-free survival

    To determine the rate of disease-free survival at 3 years

    Measured: From surgery until 3 years of follow-up

Timeline

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

  1. First posted3 Aug 2015 (estimated)
  2. Study start28 Jan 2016
  3. Primary completion9 Jun 2022
  4. Study completion30 Jun 2024

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 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
218 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02514278
Sponsor's protocol ID
CHUBX 2014/33
Other IDs
2015-001100-59, 2015
Acronym
GRECCAR12
Status last verified
Aug 2024
First submitted
6 Jul 2015
Last updated
14 May 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Vendrely V, Denost Q, Charleux T, Brouquet A, Huguet F, Rullier E. [Rectal cancer radiotherapy: Therapeutical strategy and perspective]. Cancer Radiother. 2018 Oct;22(6-7):558-563. doi: 10.1016/j.canrad.2018.06.004. Epub 2018 Aug 28. French.

    PubMed 30170787

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Neoadjuvant chemotherapy Folfirinox, 4 cycles, 50 Gy, 2 Gy/session; 25 fractions and Local excision in good responders in people with Rectal Cancer, run by University Hospital, Bordeaux at 29 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 10 inclusion and 15 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 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 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?

Rate of organ preservation and absence of stoma (time frame: 1 year after surgery). 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 NCT02514278, 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 14 May 2026.

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