Rectal CancerPhase 3NCT04495088
Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer
A Phase 3 study testing mFOLFOX (neoadjuvant), XELOX (neoadjuvant) and mFOLFOX (adjuvant) in people with Rectal Cancer, run by Ralf Hofheinz at 1 site in Germany.
Trial summary
This is a multicenter, prospective, randomized, stratified, controlled, open-label study comparing preoperative FOLFOX versus postoperative risk-adapted chemotherapy in patients with locally advanced rectal cancer and low risk for local failure 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?
- mFOLFOX (neoadjuvant), XELOX (neoadjuvant) and mFOLFOX (adjuvant)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 1 siteGermany
- Study dates
- 30 Sep 2020to 31 Jul 2026
- 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
- Male and female patients with histologically confirmed diagnosis of rectal adenocarcinoma localised 0 - 16 cm from the anocutaneous line as measured by rigid rectoscopy (i.e. lower, middle and upper third of the rectum), depending on MRI-defined inclusion criteria (see below).
- Staging requirements: High-resolution magnetic resonance imaging (MRI) of the pelvis is the mandatory local staging procedure.
- Transrectal endoscopic ultrasound (EUS) is used to help discriminate between T1/2 and early T3 tumors.
- MRI-defined inclusion criteria:
- Lower third (0-6 cm):
- cT1/2 with clear cN+ based on defined MRI criteria or T3a-b (i.e. maximum infiltration into the perirectal fat of 5mm), provided CRM > 2mm and EMVI-** ii. Middle third (≥ 6-12 cm):
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- cT1/2 with clear cN+ provided CRM- and EMVI-**
- cT3 irrespective of the depth of invasion into the perirectal fat, provided no evidence that tumor is adjacent to (defined as within 2 mm of) the mesorectal fascia on MRI (i.e. CRM > 2 mm), N0 or N1, EMVI-** iii. Upper third (≥ 12-16 cm):
- cT1/2 with clear cN+, irrespective of CRM and EMVI
- any cT3-4 irrespective of nodal status, CRM and EMVI.
- Spiral-CT of the abdomen and chest to exclude distant metastases.
- Aged at least 18 years. No upper age limit.
- WHO/ECOG Performance Status ≤1.
- Adequate haematological, hepatic, renal and metabolic function parameters:
- Leukocytes ≥ 3.000/mm³, ANC ≥ 2.000/mm³, platelets ≥ 100.000/mm³, Hb > 9 g/dl
- Serum creatinine ≤ 1.5 x upper limit of normal
- Bilirubin ≤ 2.0 mg/dl, SGOT-SGPT, and AP ≤ 3 x upper limit of normal.
- QTc interval (Bazett**) ≤ 440 ms
- Informed consent of the patient.
- "" Formula for QTc interval calculation (Bazett): QTc= ((QT) ̅" (ms)" )/√(RR (sec))= ((QT) ̅" (ms)" )/√(60/(frequency (1/min)))
Who cannot join
- Distant metastases (to be excluded by CT scan of the thorax and abdomen).
- Prior antineoplastic therapy for rectal cancer.
- Prior radiotherapy of the pelvic region.
- Major surgery within the last 4 weeks prior to inclusion.
- Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
- Subject (male or female) is not willing to use highly effective*** methods of contraception during treatment and for 6 months (male or female) after the end of treatment Male patients treated with Oxaliplatin should take legal advice concerning sperm conservation before start of therapy and should additionally use a condom during treatment period. Their female partner of childbearing potential should also use an appropriate contraceptive measure.
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- On-treatment participation in a clinical study in the period 30 days prior to inclusion.
- Previous or current drug abuse.
- Other concomitant antineoplastic therapy.
- Serious concurrent diseases, including neurologic or psychiatric disorders (incl. dementia and uncontrolled seizures), active, uncontrolled infections, active, disseminated coagulation disorder.
- Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 6 months before enrolment.
- Chronic diarrhea (> grade 1 according NCI CTCAE).
- Prior or concurrent malignancy ≤ 3 years prior to enrolment in study (Exception: non-melanoma skin cancer or cervical carcinoma FIGO stage 0-1), if the patient is continuously disease-free.
- Known allergic reactions or hypersensitivity on study medication or to any of the other excipients.
- Evidence of peripheral sensory neuropathy > grade 1 according to CTCAE version 5.0 (see appendix).
- Severe kidney dysfunction (creatinine clearance < 30 ml/min).
- Recent or concurrent treatment with brivudine.
- Pernicious or other megaloblastic anaemia caused by vitamin B12 deficiency.
- Known dihydropyrimidine dehydrogenase deficiency.
- Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule (these conditions should be discussed with the patient before registration in the trial).
- ""highly effective (i.e. failure rate of <1% per year when used consistently and correctly) methods: intravaginal and transdermal combined (estrogen and progestogen containing) hormonal contraception; injectable and implantable progestogen-only hormonal contraception; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomized partner; sexual abstinence (complete abstinence is defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer and Low Risk for Local Failure: A Randomized Phase III Trial of the German Rectal Cancer Study Group
This is a multicenter, prospective, randomized, stratified, controlled, open-label study comparing preoperative FOLFOX versus postoperative risk-adapted chemotherapy in patients with locally advanced rectal cancer and low risk for local failure
Read the detailed description
Patients with locally advanced rectal cancer are generally treated with preoperative 5-FU- or capecitabine-based chemo-radiotherapy (CRT) and total mesorectal excision (TME) surgery in order to decrease the rate of local failure. In patients with low risk for local failure in the middle third of the rectum (cT3a/b, N-) as determined with quality controlled MRI, the German S3 guidelines and the ESMO clinical practice guidelines state that neoadjuvant radiotherapy may be omitted. However, distant failure rate is still substantial in the range of 20-25% in these patients highlighting the need for more effective systemic treatment.
The hereby proposed ACO/ARO/AIO-18.2 randomized trial incorporates three novel aspects: (1) patient selection relies on strict and quality controlled MRI features and therefore identifies a cohort without imminent need for radiotherapy, (2) the sequence of chemotherapy and surgery is changed in a way that chemotherapy is administered preoperatively to increase the rate of patients treated with chemotherapy, and (3) three months of neoadjuvant FOLFOX or XELOX (instead of up to 6 months adjuvant chemotherapy) are used as a sole perioperative treatment in order to administer effective doses of the presumably most effective perioperative treatment at an early time point during the course of disease.
Thus, patients with locally advanced rectal cancer but low risk for local failure (cT1/2N+ in all thirds of the rectum, cT3a/b N- in the middle third, and cT3-4 Nany in the upper third) will be included and randomized between three months of neoadjuvant FOLFOX/XELOX in Arm A and primary resection of the tumor followed by risk (i.e. stage) adapted chemotherapy in Arm B.
- Conditions
- Rectal Cancer
- Being tested
- mFOLFOX (neoadjuvant), XELOX (neoadjuvant), mFOLFOX (adjuvant), XELOX (adjuvant), Capecitabine (adjuvant)
- Keywords
- Rectal Cancer
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mFOLFOX (neoadjuvant)Drug
Also called Folinic acid, Oxaliplatin, 5-FU
neoadjuvant application Folinic acid: 400 mg/m2, 2h i.v., on day 1 Oxaliplatin: 85 mg/m2, 2-6h i.v., on day 1 5-FU: 2400 mg/m2, 46-48h i.v., on day 1. Cycles are repeated on day 15. A total of 6 cycles are administered.
XELOX (neoadjuvant)Drug
Also called Capecitabine, Oxaliplatin
neoadjuvant application Capecitabine: 1,000 mg/m2 bid, po, on days 1-14 Oxaliplatin: 130 mg/m2, 2-6h i.v. day 1 Cycles are repeated on day 22. A total of 4 cycles are administered.
mFOLFOX (adjuvant)Drug
Also called Folinic acid, Oxaliplatin, 5-FU
adjuvant application Folinic acid: 400 mg/m2, 2h i.v., on day 1 Oxaliplatin: 85 mg/m2, 2-6h i.v., on day 1 5-FU: 2400 mg/m2, 46-48h i.v., on day 1. Cycles are repeated on day 15. A total of 6 cycles are administered.
XELOX (adjuvant)Drug
Also called Capecitabine, Oxaliplatin
adjuvant application Capecitabine: 1,000 mg/m2 bid, po, on days 1-14 Oxaliplatin: 130 mg/m2, 2-6h i.v. day 1 Cycles are repeated on day 22. A total of 4 cycles are administered.
Capecitabine (adjuvant)Drug
Also called Capecitabine
adjuvant application Capecitabine: 1,250 mg/m2 bid, po, on days 1-14 Cycles are repeated on day 22. A total of 8 cycles are administered.
infusional 5-FU/FA "AIO" regimen (adjuvant)Drug
Also called 5-FU, Folinic acid
adjuvant application Folinic acid 2h i.v. 500 mg/m² 5-FU 2,600mg/m² (24h infusion) Days 1, 8, 15, 22, 29, 36; cycle is repeated day 57 (representing one cycle); a total of 3 cycles should be administered.
infusional 5-FU/FA "de Gramont" (adjuvant)Drug
Also called 5-FU, Folinic acid
adjuvant application Folinic acid 2h i.v. 200 mg/m² days 1 and 2 5-FU 400mg/m² bolus followed by 600mg/m² 22h infusion days 1 and 2 The cycle is repeated day 15; a total of 12 cycles should be administered.
| Study group | Role | What they receive |
|---|---|---|
| A (experimental arm) | Experimental | The experimental arm A starts with 6 cycles of mFOLFOX or 4 cycles of XELOX. Surgery is scheduled four or six weeks after day 1 of the last mFOLFOX or XELOX cycle, respectively. No postoperative chemotherapy is planned Receives: Drug: mFOLFOX (neoadjuvant); Drug: XELOX (neoadjuvant) |
| B (control arm) | Active comparator | In the standard arm B, patients undergo surgical resection of the primary tumor followed by stage- (risk-)adapted adjuvant chemotherapy 4-8 weeks after surgery according to recommendations of the S3 guidelines in analogy to colon cancer. Details of the recommended protocols are provided in the protocol. Receives: Drug: mFOLFOX (adjuvant); Drug: XELOX (adjuvant); Drug: Capecitabine (adjuvant); Drug: infusional 5-FU/FA "AIO" regimen (adjuvant); Drug: infusional 5-FU/FA "de Gramont" (adjuvant) |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-free survival
time from randomisation to one of the following events: no surgery or non-radical (R2) surgery of the primary tumour, locoregional recurrence after R0/1 resection of the primary tumour, second primary colorectal or other cancer, metastatic disease or progression, or death from any cause, whichever occurred first.
Measured: up to 3 years
Secondary outcomes (13)
Acute and late toxicity
assessment of acute and late toxicity according to NCI CTCAE version 5.0
Measured: From date of informed consent until the End of Treatment or 30 days after the last dose of study treatment
Compliance (completion rate) of chemotherapy
Rate of completion of administered chemotherapy
Measured: From date of randomization until end of chemotherapy, approx. 12 (arm A) respectively up to 34 (arm B) weeks after randomization
Surgical morbidity and complications
Surgical morbidity and complications if surgery is performed and events occur
Measured: After surgery, approx. 2 (arm B) respectively 20 (arm A) weeks after randomization
Pathological UICC-staging, including pCR (ypT0N0) rate
Pathological staging according UICC criteria, including detailed information about pathologically assessed complete response rate (ypT0N0)
Measured: After surgery, approx. 2 (arm B) respectively 20 (arm A) weeks after randomization
R0 resection rate, Negative circumferential resection rate (CRM > 1mm)
defined as microscopically margin negative resection with no gross or microscopic tumor remains in the area of the primary tumor and/or samples regional lymph nodes based on evaluation by the local pathologist
Measured: After surgery, approx. 2 (arm B) respectively 20 (arm A) weeks after randomization
Tumor regression grading according to Dworak in the experimental arm
Grading of tumor regression according to Dworak in the experimental arm
Measured: After surgery, approx. 2 (arm B) respectively 20 (arm A) weeks after randomization
Rate of sphincter-sparing surgery
Rate of sphincter-sparing surgery if surgery is performed
Measured: After surgery, approx. 2 (arm B) respectively 20 (arm A) weeks after randomization
Rate of W&W with or without local regrowth
Number of performed watch\&wait approaches with or without local regrowth compared to planned and performed surgery
Measured: Up to 5 years after end of treatment
Cumulative incidence of local and distant recurrences
Total number of local and distant recurrences, if they occur
Measured: Up to 5 years after end of treatment
Overall survival
Overall survival is defined as the time interval between the date of randomization and the date of death of any cause. Patients who are still alive when last traced will be censored at the date of last follow-up
Measured: Up to at least 3 years and until 5 years
Patient reported outcome: Quality of life according to questionnaire EORTC-QLQ-C30
Quality of life scores according to validated questionnaires EORTC-QLQ-C30, based on treatment arm, and surgical procedures. 30 questions; score values from 1 (not at all) to 4 (very much) respectively from 1 (very poor) to 7 (excellent). Score outcome depends on score type.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever occured first, assessed up to approximately 68 months
Patient reported outcome: Quality of life according to questionnaire EORTC-QLQ-CR29
Quality of life scores according to validated questionnaires EORTC-QLQ-CR29, based on treatment arm, and surgical procedures. 29 questions; score values from 1 (not at all) to 4 (very much). Score outcome depends on score type.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever occured first, assessed up to approximately 68 months
Patient reported outcome: Functional outcome according to Wexner score
Functional score according to validated Wexner score, based on treatment arm, and surgical procedures. 5 questions; five score values from "never" to "1 per day or more often". The more often the worse the outcome.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever occured first, assessed up to approximately 68 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start30 Sep 2020
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Why it stopped: poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- 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
- Model description
- multicenter, randomized, two-armed
- Masking
- None (open label)
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ralf Hofheinz
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Krebshilfe e.V., Bonn (Germany), Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest, German Rectal Cancer Study Group
- Responsible party
- Sponsor-investigator, Ralf Hofheinz, Universitätsmedizin Mannheim
- Investigators
- Ralf-Dieter Hofheinz, Prof. Dr., Principal investigator, Universitätsmedizin Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04495088
- Sponsor's protocol ID
- ACO/ARO/AIO-18.2
- Other IDs
- 2018-001356-35, 2018
- Status last verified
- Sep 2026
- First submitted
- 28 Jul 2020
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer and Low Risk for Local Failure: A Randomized Phase III Trial of the German Rectal Cancer Study Group
- ClinicalTrials.gov ID
- NCT04495088
- Acronym / sponsor ID
- ACO/ARO/AIO-18.2
- Conditions
- Rectal Cancer
- Keywords
- Rectal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor accrual
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Ralf HofheinzUniversity, hospital or other
- Collaborators
- Deutsche Krebshilfe e.V., Bonn (Germany), Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest, German Rectal Cancer Study Group
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 31 Jul 2020 (actual)
- 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.
This is a multicenter, prospective, randomized, stratified, controlled, open-label study comparing preoperative FOLFOX versus postoperative risk-adapted chemotherapy in patients with locally advanced rectal cancer and low risk for local failure
Detailed description
Patients with locally advanced rectal cancer are generally treated with preoperative 5-FU- or capecitabine-based chemo-radiotherapy (CRT) and total mesorectal excision (TME) surgery in order to decrease the rate of local failure. In patients with low risk for local failure in the middle third of the rectum (cT3a/b, N-) as determined with quality controlled MRI, the German S3 guidelines and the ESMO clinical practice guidelines state that neoadjuvant radiotherapy may be omitted. However, distant failure rate is still substantial in the range of 20-25% in these patients highlighting the need for more effective systemic treatment.
The hereby proposed ACO/ARO/AIO-18.2 randomized trial incorporates three novel aspects: (1) patient selection relies on strict and quality controlled MRI features and therefore identifies a cohort without imminent need for radiotherapy, (2) the sequence of chemotherapy and surgery is changed in a way that chemotherapy is administered preoperatively to increase the rate of patients treated with chemotherapy, and (3) three months of neoadjuvant FOLFOX or XELOX (instead of up to 6 months adjuvant chemotherapy) are used as a sole perioperative treatment in order to administer effective doses of the presumably most effective perioperative treatment at an early time point during the course of disease.
Thus, patients with locally advanced rectal cancer but low risk for local failure (cT1/2N+ in all thirds of the rectum, cT3a/b N- in the middle third, and cT3-4 Nany in the upper third) will be included and randomized between three months of neoadjuvant FOLFOX/XELOX in Arm A and primary resection of the tumor followed by risk (i.e. stage) adapted chemotherapy in Arm B.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- multicenter, randomized, two-armed
| Arm | Type | Receives |
|---|---|---|
| A (experimental arm) | Experimental | Drug: mFOLFOX (neoadjuvant), Drug: XELOX (neoadjuvant)The experimental arm A starts with 6 cycles of mFOLFOX or 4 cycles of XELOX. Surgery is scheduled four or six weeks after day 1 of the last mFOLFOX or XELOX cycle, respectively. No postoperative chemotherapy is planned |
| B (control arm) | Active comparator | Drug: mFOLFOX (adjuvant), Drug: XELOX (adjuvant), Drug: Capecitabine (adjuvant), Drug: infusional 5-FU/FA "AIO" regimen (adjuvant), Drug: infusional 5-FU/FA "de Gramont" (adjuvant)In the standard arm B, patients undergo surgical resection of the primary tumor followed by stage- (risk-)adapted adjuvant chemotherapy 4-8 weeks after surgery according to recommendations of the S3 guidelines in analogy to colon cancer. Details of the recommended protocols are provided in the protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Male and female patients with histologically confirmed diagnosis of rectal adenocarcinoma localised 0 - 16 cm from the anocutaneous line as measured by rigid rectoscopy (i.e. lower, middle and upper third of the rectum), depending on MRI-defined inclusion criteria (see below).
- Staging requirements: High-resolution magnetic resonance imaging (MRI) of the pelvis is the mandatory local staging procedure.
- Transrectal endoscopic ultrasound (EUS) is used to help discriminate between T1/2 and early T3 tumors.
- MRI-defined inclusion criteria:
- Spiral-CT of the abdomen and chest to exclude distant metastases.
Key exclusion criteria (21 listed)
- Distant metastases (to be excluded by CT scan of the thorax and abdomen).
- Prior antineoplastic therapy for rectal cancer.
- Prior radiotherapy of the pelvic region.
- Major surgery within the last 4 weeks prior to inclusion.
- Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
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 |
|---|---|---|
| mFOLFOX (neoadjuvant)Also: Folinic acid, Oxaliplatin, 5-FUneoadjuvant application Folinic acid: 400 mg/m2, 2h i.v., on day 1 Oxaliplatin: 85 mg/m2, 2-6h i.v., on day 1 5-FU: 2400 mg/m2, 46-48h i.v., on day 1. Cycles are repeated on day 15. A total of 6 cycles are administered. | Drug | A (experimental arm) |
| XELOX (neoadjuvant)Also: Capecitabine, Oxaliplatinneoadjuvant application Capecitabine: 1,000 mg/m2 bid, po, on days 1-14 Oxaliplatin: 130 mg/m2, 2-6h i.v. day 1 Cycles are repeated on day 22. A total of 4 cycles are administered. | Drug | A (experimental arm) |
| mFOLFOX (adjuvant)Also: Folinic acid, Oxaliplatin, 5-FUadjuvant application Folinic acid: 400 mg/m2, 2h i.v., on day 1 Oxaliplatin: 85 mg/m2, 2-6h i.v., on day 1 5-FU: 2400 mg/m2, 46-48h i.v., on day 1. Cycles are repeated on day 15. A total of 6 cycles are administered. | Drug | B (control arm) |
| XELOX (adjuvant)Also: Capecitabine, Oxaliplatinadjuvant application Capecitabine: 1,000 mg/m2 bid, po, on days 1-14 Oxaliplatin: 130 mg/m2, 2-6h i.v. day 1 Cycles are repeated on day 22. A total of 4 cycles are administered. | Drug | B (control arm) |
| Capecitabine (adjuvant)Also: Capecitabineadjuvant application Capecitabine: 1,250 mg/m2 bid, po, on days 1-14 Cycles are repeated on day 22. A total of 8 cycles are administered. | Drug | B (control arm) |
| infusional 5-FU/FA "AIO" regimen (adjuvant)Also: 5-FU, Folinic acidadjuvant application Folinic acid 2h i.v. 500 mg/m² 5-FU 2,600mg/m² (24h infusion) Days 1, 8, 15, 22, 29, 36; cycle is repeated day 57 (representing one cycle); a total of 3 cycles should be administered. | Drug | B (control arm) |
| infusional 5-FU/FA "de Gramont" (adjuvant)Also: 5-FU, Folinic acidadjuvant application Folinic acid 2h i.v. 200 mg/m² days 1 and 2 5-FU 400mg/m² bolus followed by 600mg/m² 22h infusion days 1 and 2 The cycle is repeated day 15; a total of 12 cycles should be administered. | Drug | B (control arm) |
Primary outcome
disease-free survival
Time frame: up to 3 years
time from randomisation to one of the following events: no surgery or non-radical (R2) surgery of the primary tumour, locoregional recurrence after R0/1 resection of the primary tumour, second primary colorectal or other cancer, metastatic disease or progression, or death from any cause, whichever occurred first.
13 secondary outcomes
Acute and late toxicity
Time frame: From date of informed consent until the End of Treatment or 30 days after the last dose of study treatment
Compliance (completion rate) of chemotherapy
Time frame: From date of randomization until end of chemotherapy, approx. 12 (arm A) respectively up to 34 (arm B) weeks after randomization
Surgical morbidity and complications
Time frame: After surgery, approx. 2 (arm B) respectively 20 (arm A) weeks after randomization
Pathological UICC-staging, including pCR (ypT0N0) rate
Time frame: After surgery, approx. 2 (arm B) respectively 20 (arm A) weeks after randomization
R0 resection rate, Negative circumferential resection rate (CRM > 1mm)
Time frame: After surgery, approx. 2 (arm B) respectively 20 (arm A) weeks after randomization
Tumor regression grading according to Dworak in the experimental arm
Time frame: After surgery, approx. 2 (arm B) respectively 20 (arm A) weeks after randomization
Rate of sphincter-sparing surgery
Time frame: After surgery, approx. 2 (arm B) respectively 20 (arm A) weeks after randomization
Rate of W&W with or without local regrowth
Time frame: Up to 5 years after end of treatment
Cumulative incidence of local and distant recurrences
Time frame: Up to 5 years after end of treatment
Overall survival
Time frame: Up to at least 3 years and until 5 years
Patient reported outcome: Quality of life according to questionnaire EORTC-QLQ-C30
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever occured first, assessed up to approximately 68 months
Patient reported outcome: Quality of life according to questionnaire EORTC-QLQ-CR29
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever occured first, assessed up to approximately 68 months
Patient reported outcome: Functional outcome according to Wexner score
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever occured first, assessed up to approximately 68 months
Results and safety
The study was stopped early (reason given: poor accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Ralf-Dieter Hofheinz, Prof. Dr. principal investigator
Universitätsmedizin Mannheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing mFOLFOX (neoadjuvant), XELOX (neoadjuvant) and mFOLFOX (adjuvant) in people with Rectal Cancer, run by Ralf Hofheinz at 1 site in Germany.
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 20 inclusion and 21 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: stopped early, as of the sponsor's last update on 2 Oct 2026. 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 Germany. 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 was stopped early (reason given: poor accrual). Results are not available in the source record.
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: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2026.