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Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer

Primary Purpose

Rectal Cancer

Status
Recruiting
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
mFOLFOX (neoadjuvant)
XELOX (neoadjuvant)
mFOLFOX (adjuvant)
XELOX (adjuvant)
Capecitabine (adjuvant)
infusional 5-FU/FA "AIO" regimen (adjuvant)
infusional 5-FU/FA "de Gramont" (adjuvant)
Sponsored by
Ralf Hofheinz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring Rectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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).
  2. Staging requirements: High-resolution magnetic resonance imaging (MRI) of the pelvis is the mandatory local staging procedure.
  3. Transrectal endoscopic ultrasound (EUS) is used to help discriminate between T1/2 and early T3 tumors.
  4. MRI-defined inclusion criteria:

    • Lower third (0-6 cm): cT1/2 with clear cN+ based on MRI-criteria (see SOP in chapter 13.3 of the appendix), provided CRM- and EMVI- (defined as MRI-EMVI score 0-3; see SOP in chapter 13.3 of the appendix)
    • Middle third (≥ 6-12 cm): cT1/2 with clear cN+ provided CRM- and EMVI-; cT3a/b, i.e. evidence of extramural tumor spread into the mesorectal fat of ≤ 5 mm provided N-, CRM-, and EMVI-
    • Upper third (≥ 12-16 cm): cT1/2 with clear cN+ provided CRM- and EMVI-; any cT3-4 irrespective of nodal status.
  5. Spiral-CT of the abdomen and chest to exclude distant metastases.
  6. Aged at least 18 years. No upper age limit.
  7. WHO/ECOG Performance Status ≤1.
  8. Adequate haematological, hepatic, renal and metabolic function parameters:
  9. Leukocytes ≥ 3.000/mm³, ANC ≥ 2.000/mm³, platelets ≥ 100.000/mm³, Hb > 9 g/dl
  10. Serum creatinine ≤ 1.5 x upper limit of normal
  11. Bilirubin ≤ 2.0 mg/dl, SGOT-SGPT, and AP ≤ 3 x upper limit of normal.
  12. QTc interval (Bazett**) ≤ 440 ms
  13. Informed consent of the patient.

"**" Formula for QTc interval calculation (Bazett): QTc= ((QT) ̅" (ms)" )/√(RR (sec))= ((QT) ̅" (ms)" )/√(60/(frequency (1/min)))

Exclusion Criteria:

  1. Distant metastases (to be excluded by CT scan of the thorax and abdomen).
  2. Prior antineoplastic therapy for rectal cancer.
  3. Prior radiotherapy of the pelvic region.
  4. Major surgery within the last 4 weeks prior to inclusion.
  5. Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
  6. 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.
  7. On-treatment participation in a clinical study in the period 30 days prior to inclusion.
  8. Previous or current drug abuse.
  9. Other concomitant antineoplastic therapy.
  10. Serious concurrent diseases, including neurologic or psychiatric disorders (incl. dementia and uncontrolled seizures), active, uncontrolled infections, active, disseminated coagulation disorder.
  11. Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 6 months before enrolment.
  12. Chronic diarrhea (> grade 1 according NCI CTCAE).
  13. 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.
  14. Known allergic reactions or hypersensitivity on study medication or to any of the other excipients.
  15. Evidence of peripheral sensory neuropathy > grade 1 according to CTCAE version 5.0 (see appendix).
  16. Severe kidney dysfunction (creatinine clearance < 30 ml/min).
  17. Recent or concurrent treatment with brivudine.
  18. Pernicious or other megaloblastic anaemia caused by vitamin B12 deficiency.
  19. Known dihydropyrimidine dehydrogenase deficiency.
  20. 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).

Sites / Locations

  • Unversity Hospital MannheimRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A (experimental arm)

B (control arm)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Acute and late toxicity
assessment of acute and late toxicity according to NCI CTCAE version 5.0
Compliance (completion rate) of chemotherapy
Rate of completion of administered chemotherapy
Surgical morbidity and complications
Surgical morbidity and complications if surgery is performed and events occur
Pathological UICC-staging, including pCR (ypT0N0) rate
Pathological staging according UICC criteria, including detailed information about pathologically assessed complete response rate (ypT0N0)
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
Tumor regression grading according to Dworak in the experimental arm
Grading of tumor regression according to Dworak in the experimental arm
Rate of sphincter-sparing surgery
Rate of sphincter-sparing surgery if surgery is performed
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
Cumulative incidence of local and distant recurrences
Total number of local and distant recurrences, if they occur
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
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.
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.
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.

Full Information

First Posted
July 28, 2020
Last Updated
August 12, 2022
Sponsor
Ralf Hofheinz
Collaborators
Deutsche Krebshilfe e.V., Bonn (Germany), Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest, German Rectal Cancer Study Group
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1. Study Identification

Unique Protocol Identification Number
NCT04495088
Brief Title
Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2020 (Actual)
Primary Completion Date
August 2030 (Anticipated)
Study Completion Date
August 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ralf Hofheinz
Collaborators
Deutsche Krebshilfe e.V., Bonn (Germany), Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest, German Rectal Cancer Study Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
Rectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
multicenter, randomized, two-armed
Masking
None (Open Label)
Masking Description
open-label
Allocation
Randomized
Enrollment
818 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A (experimental arm)
Arm Type
Experimental
Arm Description
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
Arm Title
B (control arm)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
mFOLFOX (neoadjuvant)
Other Intervention Name(s)
Folinic acid, Oxaliplatin, 5-FU
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
XELOX (neoadjuvant)
Other Intervention Name(s)
Capecitabine, Oxaliplatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
mFOLFOX (adjuvant)
Other Intervention Name(s)
Folinic acid, Oxaliplatin, 5-FU
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
XELOX (adjuvant)
Other Intervention Name(s)
Capecitabine, Oxaliplatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Capecitabine (adjuvant)
Other Intervention Name(s)
Capecitabine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
infusional 5-FU/FA "AIO" regimen (adjuvant)
Other Intervention Name(s)
5-FU, Folinic acid
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
infusional 5-FU/FA "de Gramont" (adjuvant)
Other Intervention Name(s)
5-FU, Folinic acid
Intervention Description
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.
Primary Outcome Measure Information:
Title
disease-free survival
Description
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.
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
Acute and late toxicity
Description
assessment of acute and late toxicity according to NCI CTCAE version 5.0
Time Frame
From date of informed consent until the End of Treatment or 30 days after the last dose of study treatment
Title
Compliance (completion rate) of chemotherapy
Description
Rate of completion of administered chemotherapy
Time Frame
From date of randomization until end of chemotherapy, approx. 12 (arm A) respectively up to 34 (arm B) weeks after randomization
Title
Surgical morbidity and complications
Description
Surgical morbidity and complications if surgery is performed and events occur
Time Frame
After surgery, approx. 2 (arm B) respectively 20 (arm A) weeks after randomization
Title
Pathological UICC-staging, including pCR (ypT0N0) rate
Description
Pathological staging according UICC criteria, including detailed information about pathologically assessed complete response rate (ypT0N0)
Time Frame
After surgery, approx. 2 (arm B) respectively 20 (arm A) weeks after randomization
Title
R0 resection rate, Negative circumferential resection rate (CRM > 1mm)
Description
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
Time Frame
After surgery, approx. 2 (arm B) respectively 20 (arm A) weeks after randomization
Title
Tumor regression grading according to Dworak in the experimental arm
Description
Grading of tumor regression according to Dworak in the experimental arm
Time Frame
After surgery, approx. 2 (arm B) respectively 20 (arm A) weeks after randomization
Title
Rate of sphincter-sparing surgery
Description
Rate of sphincter-sparing surgery if surgery is performed
Time Frame
After surgery, approx. 2 (arm B) respectively 20 (arm A) weeks after randomization
Title
Rate of W&W with or without local regrowth
Description
Number of performed watch&wait approaches with or without local regrowth compared to planned and performed surgery
Time Frame
Up to 5 years after end of treatment
Title
Cumulative incidence of local and distant recurrences
Description
Total number of local and distant recurrences, if they occur
Time Frame
Up to 5 years after end of treatment
Title
Overall survival
Description
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
Time Frame
Up to at least 3 years and until 5 years
Title
Patient reported outcome: Quality of life according to questionnaire EORTC-QLQ-C30
Description
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.
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
Title
Patient reported outcome: Quality of life according to questionnaire EORTC-QLQ-CR29
Description
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.
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
Title
Patient reported outcome: Functional outcome according to Wexner score
Description
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 MRI-criteria (see SOP in chapter 13.3 of the appendix), provided CRM- and EMVI- (defined as MRI-EMVI score 0-3; see SOP in chapter 13.3 of the appendix) Middle third (≥ 6-12 cm): cT1/2 with clear cN+ provided CRM- and EMVI-; cT3a/b, i.e. evidence of extramural tumor spread into the mesorectal fat of ≤ 5 mm provided N-, CRM-, and EMVI- Upper third (≥ 12-16 cm): cT1/2 with clear cN+ provided CRM- and EMVI-; any cT3-4 irrespective of nodal status. 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))) Exclusion Criteria: 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. 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ralf-Dieter Hofheinz, Prof. Dr.
Phone
+49 621 383
Ext
2855
Email
ralf.hofheinz@umm.de
First Name & Middle Initial & Last Name or Official Title & Degree
Benedict Atzler
Phone
+49 69 7601
Ext
7052
Email
atzler.benedict@ikf-khnw.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralf-Dieter Hofheinz, Prof. Dr.
Organizational Affiliation
Universitätsmedizin Mannheim
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unversity Hospital Mannheim
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ralf Hofheinz, Prof.
Phone
+49 621 383 2855
Email
Ralf.Hofheinz@umm.de

12. IPD Sharing Statement

Plan to Share IPD
No

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Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer

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