Rectal CancerPhase 2CAO/ARO/AIO-16NCT03561142
Organ Preservation in Locally Advanced Rectal Cancer by Radiochemotherapy Followed by Consolidation Chemotherapy.
A Phase 2 study testing Radiotherapy, Chemotherapy and Deep regional hyperthermia in people with Rectal Cancer and Rectal Neoplasms, run by University Hospital Tuebingen at 4 sites in Germany.
Trial summary
There is a growing body of evidence that surgery and associated morbidities can be omitted without compromising oncological safety in selected patients who have achieved a clinical complete response after radiochemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Rectal Neoplasms, Rectal Cancer Stage II
- What is being tested?
- Radiotherapy, Chemotherapy and Deep regional hyperthermia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 4 sitesGermany
- Study dates
- 15 Jun 2018to 16 Apr 2024
- Phase
- Phase 2
- 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 cancer localized 0 - 12 cm from the anocutaneous line as measured by rigid rectoscopy (i.e. lower and middle third of the rectum)
- Any MRI staged cT3 tumor or any cT1 cN+ or cT2 cN+ with nodal staging according to "SOP MRI"
- Staging requirements: High-resolution, thin-sliced (i.e. 3mm) magnetic resonance imaging (MRI) of the pelvis is the mandatory local staging procedure.
- Cross-sectional imaging of the abdomen and chest to exclude distant metastases.
- Aged at least 18 years. No upper age limit.
- WHO/ECOG Performance Status ≤ 1
- Adequate hematological, hepatic, renal and metabolic function parameters
- Informed consent of the patient
Who cannot join
- Lower border of the tumor localised more than 12 cm from the anocutaneous line as measured by rigid rectoscopy
- cT4 tumors
- Positive lateral pelvic lymph nodes
- Distant metastases (to be excluded by CT scan of the thorax and abdomen)
- Preexisting fecal incontinence for solid stool
- Preexisting peripheral sensory neuropathy with functional impairment
Show all 26Show fewer
- Preexisting myelosuppression reflected by a neutrophil count < 2.000/mm^3 and/or platelets < 100.000/mm^3
- Severe impairment of kidney function with a Creatinin Clearance < 30 ml/min)
- 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 according to the "Clinical trial fertility group"
- On-treatment participation in an interventional 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, severe liver function disorders
- WHO/ECOG Performance Status > 1
- Clinically significant cardiovascular disease (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 on study medication
- Known dihydropyrimidine dehydrogenase deficiency
- Medication inhibitors of the dihydropyrimidine dehydrogenase, such as Brivudin, Sorivudin and its analogues.
- Pernicious anemia or other anemias caused by Vitamin B-12 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).
- Additionally for hyperthermia cardiac pacemakers and metal implants in the proximity of the pelvis constitute a criterion for exclusion.
Trial locations and contacts
4 sites in 1 country.
Germany4 sites, 4 recruiting
- Not yet recruiting
University Hospital Erlangen
Erlangen
Oliver Ott, Prof.
- Not yet recruiting
University Hospital Frankfurt
Frankfurt
Claus Rödel, Prof.
- Recruiting
University Hospital Tübingen
Tübingen
Cihan Gani, Dr.
- Not yet recruiting
University Hospital Würzburg
Würzburg
Bülent Polat, Dr.
About this study
Official title: Organ Preservation in Locally Advanced Rectal Cancer by Radiochemotherapy Followed by Consolidation Chemotherapy. A Prospective Phase II Pilot Trial of the German Rectal Cancer Study Group
There is a growing body of evidence that surgery and associated morbidities can be omitted without compromising oncological safety in selected patients who have achieved a clinical complete response after radiochemotherapy. However with standard neoadjuvant treatment regimens the pathological complete response rate lies in the range between 10%-20%, the number of patients qualifying for non-operative management is even lower since the sensitivity of currently available diagnostic measures for predicting the pathological complete response hardly surpasses 50%-60%.The hereby proposed phase II trial CAO/ARO/AIO-16 aims at finding novel and innovative aspects of rectal cancer treatment. According to recently published data the radiochemotherapy regime in the present study with consolidating chemotherapy and delayed assessment of response has the potential to achieve pathological complete rates of approximately 40%. A standardized re-evaluation after consolidating chemotherapy will select patients who are candidates for organ-preservation. These patients will not undergo radical surgery and will instead be follow-up closely for tumor regrowth.
- Being tested
- Radiotherapy, Chemotherapy, Deep regional hyperthermia
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Radiotherapy: 28 x 1.8 Gy (total: 50.4 Gy), 5 fractions per week on day 1- 38
ChemotherapyDrug
Also called all brands of the used drugs are allowed
chemoradiotherapy is started according to the following schedule: 5-FU: 250 mg/sqm per day, iv, on day 1-14, day 22-35; Oxaliplatin: 50 mg/sqm, day 1, 8, 22, and 29. After a break of two and a half weeks, patients receive three chemotherapy cycles, starting on day 57, 71 and 85, consisting of: Folinic acid: 400 mg/sqm, 2h-iv; Oxaliplatin: 100 mg/sqm, 2h-iv; 5-FU: 2400 mg/sqm, 46h-iv
Deep regional hyperthermiaOther
Deep regional hyperthermia to the pelvis, total time 90 min, target temperature 41-42°C. Twice weekly, up to a total of 10 sessions within d1 and d38.
Deep regional hyperthermia is offered at the centers in Tübingen and Erlangen.
| Study group | Role | What they receive |
|---|---|---|
| Radiochemotherapy -> chemotherapy. | Experimental | Radiochemotherapy followed by consolidation chemotherapy. Deep regional hyperthermia can additionally be performed at the centers in Tübingen and Erlangen. Receives: Radiation: Radiotherapy; Drug: Chemotherapy; Other: Deep regional hyperthermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical complete response rate
Response to treatment is assessed on day 106 after the start of radiochemotherapy.
A clinical complete response is defined by standardized findings in rectoscopy, MRI and digital rectal examination
Measured: Day 106 after the start of treatment
Secondary outcomes (13)
Local regrowth rate
Measured: 4 years
Safety of the treatment (toxicity assessment according to NCI CTCAE Version 4.0)
Measured: 4 years
Fecal incontinence according to Wexner-Vaizey Score
Possible scores range from 0 (perfect continence) to 24 (complete incontinence)
Measured: 4 years
Quality of life according to EORTC Quality of Life questionnaire - C30
Measured: 4 years
Quality of life according to EORTC Quality of Life questionnaire - CR29
Measured: 4 years
Frequency of Low anterior resection syndrome (LARS-scale)
Measured: 4 years
Surgical morbidity in patients undergoing surgery
Measured: up to 30 days after surgery
Surgical complications in patients undergoing surgery
Measured: up to 30 days after surgery
Pathological staging, tumor downstaging (assessed by ypTNM findings in relation to initial cTNM staging), tumor regression grading according to Dworak in patients undergoing surgery
Measured: Day 123 after the start of treatment
R0 resection rate, rate of circumferential resection margin negativity (> 1mm) in patients undergoing surgery
Measured: Day 123 after the start of treatment
Rate of sphincter-sparing surgery in patients undergoing surgery
Measured: Day 123 after the start of treatment
Relapse-free survival (local / distant / overall)
Measured: 4 years
Overall survival
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start15 Jun 2018 (estimated)
- Primary completion16 Apr 2020 (estimated)
- Study completion16 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients will undergo different treatments based on response achieved after radiochemotherapy. 1. Clinical Complete Response: Omission of surgery and follow-up 2. Near clinical complete response: Reevaluation in three months 3. Poor / no response: Surgery
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cihan Gani, Dr., Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03561142
- Sponsor's protocol ID
- CAOAROAIO16
- Acronym
- CAO/ARO/AIO-16
- Status last verified
- Apr 2018
- First submitted
- 19 Apr 2018
- Last updated
- 19 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gani C, Bonomo P, Zwirner K, Schroeder C, Menegakis A, Rodel C, Zips D. Organ preservation in rectal cancer - Challenges and future strategies. Clin Transl Radiat Oncol. 2017 Mar 23;3:9-15. doi: 10.1016/j.ctro.2017.02.002. eCollection 2017 Apr.
PubMed 29658007Schroeder C, Gani C, Lamprecht U, von Weyhern CH, Weinmann M, Bamberg M, Berger B. Pathological complete response and sphincter-sparing surgery after neoadjuvant radiochemotherapy with regional hyperthermia for locally advanced rectal cancer compared with radiochemotherapy alone. Int J Hyperthermia. 2012;28(8):707-14. doi: 10.3109/02656736.2012.722263. Epub 2012 Sep 24.
PubMed 23006132Rodel C, Graeven U, Fietkau R, Hohenberger W, Hothorn T, Arnold D, Hofheinz RD, Ghadimi M, Wolff HA, Lang-Welzenbach M, Raab HR, Wittekind C, Strobel P, Staib L, Wilhelm M, Grabenbauer GG, Hoffmanns H, Lindemann F, Schlenska-Lange A, Folprecht G, Sauer R, Liersch T; German Rectal Cancer Study Group. Oxaliplatin added to fluorouracil-based preoperative chemoradiotherapy and postoperative chemotherapy of locally advanced rectal cancer (the German CAO/ARO/AIO-04 study): final results of the multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2015 Aug;16(8):979-89. doi: 10.1016/S1470-2045(15)00159-X. Epub 2015 Jul 15.
PubMed 26189067Diefenhardt M, Fokas E, Kosmala R, Polat B, Germer CT, Schlenska-Lange A, Kuhnt T, Ghadimi M, Rieken S, Wiegering A, Schwarzbach M, Fleischmann M, Grutzmann R, Ott OJ, Martus P, Konigsrainer A, Zips D, Hofheinz RD, Gani C, Rodel C. Organ Preservation and Quality of Life After Total Neoadjuvant Treatment in Rectal Cancer. JAMA Netw Open. 2026 Oct 1;9(10):e2639063. doi: 10.1001/jamanetworkopen.2026.39063.
PubMed 42879156Gani C, Fokas E, Polat B, Ott OJ, Diefenhardt M, Konigsrainer A, Boke S, Kirschniak A, Bachmann R, Wichmann D, Bitzer M, Clasen S, Grosse U, Hoffmann R, Gotz M, Hofheinz RD, Germer E, Germer CT, Fietkau R, Martus P, Zips D, Rodel C. Organ preservation after total neoadjuvant therapy for locally advanced rectal cancer (CAO/ARO/AIO-16): an open-label, multicentre, single-arm, phase 2 trial. Lancet Gastroenterol Hepatol. 2025 Jun;10(6):562-572. doi: 10.1016/S2468-1253(25)00049-4.
PubMed 40347958
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Organ Preservation in Locally Advanced Rectal Cancer by Radiochemotherapy Followed by Consolidation Chemotherapy. A Prospective Phase II Pilot Trial of the German Rectal Cancer Study Group
- ClinicalTrials.gov ID
- NCT03561142
- Acronym / sponsor ID
- CAO/ARO/AIO-16 / CAOAROAIO16
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 15 Jun 2018 (estimated)
- Primary completion
- 16 Apr 2020 (estimated)
- Study completion
- 16 Apr 2024 (estimated)
- First posted
- 19 Jun 2018 (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.
There is a growing body of evidence that surgery and associated morbidities can be omitted without compromising oncological safety in selected patients who have achieved a clinical complete response after radiochemotherapy. However with standard neoadjuvant treatment regimens the pathological complete response rate lies in the range between 10%-20%, the number of patients qualifying for non-operative management is even lower since the sensitivity of currently available diagnostic measures for predicting the pathological complete response hardly surpasses 50%-60%.The hereby proposed phase II trial CAO/ARO/AIO-16 aims at finding novel and innovative aspects of rectal cancer treatment. According to recently published data the radiochemotherapy regime in the present study with consolidating chemotherapy and delayed assessment of response has the potential to achieve pathological complete rates of approximately 40%. A standardized re-evaluation after consolidating chemotherapy will select patients who are candidates for organ-preservation. These patients will not undergo radical surgery and will instead be follow-up closely for tumor regrowth.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients will undergo different treatments based on response achieved after radiochemotherapy. 1. Clinical Complete Response: Omission of surgery and follow-up 2. Near clinical complete response: Reevaluation in three months 3. Poor / no response: Surgery
| Arm | Type | Receives |
|---|---|---|
| Radiochemotherapy -> chemotherapy. | Experimental | Radiation: Radiotherapy, Drug: Chemotherapy, Other: Deep regional hyperthermiaRadiochemotherapy followed by consolidation chemotherapy. Deep regional hyperthermia can additionally be performed at the centers in Tübingen and Erlangen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female patients with histologically confirmed diagnosis of rectal cancer localized 0 - 12 cm from the anocutaneous line as measured by rigid rectoscopy (i.e. lower and middle third of the rectum)
- Any MRI staged cT3 tumor or any cT1 cN+ or cT2 cN+ with nodal staging according to "SOP MRI"
- Staging requirements: High-resolution, thin-sliced (i.e. 3mm) magnetic resonance imaging (MRI) of the pelvis is the mandatory local staging procedure.
- Cross-sectional imaging of the abdomen and chest to exclude distant metastases.
- Aged at least 18 years. No upper age limit.
Key exclusion criteria (26 listed)
- Lower border of the tumor localised more than 12 cm from the anocutaneous line as measured by rigid rectoscopy
- cT4 tumors
- Positive lateral pelvic lymph nodes
- Distant metastases (to be excluded by CT scan of the thorax and abdomen)
- Preexisting fecal incontinence for solid stool
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 |
|---|---|---|
| RadiotherapyRadiotherapy: 28 x 1.8 Gy (total: 50.4 Gy), 5 fractions per week on day 1- 38 | Radiation | Radiochemotherapy -> chemotherapy. |
| ChemotherapyAlso: all brands of the used drugs are allowedchemoradiotherapy is started according to the following schedule: 5-FU: 250 mg/sqm per day, iv, on day 1-14, day 22-35; Oxaliplatin: 50 mg/sqm, day 1, 8, 22, and 29. After a break of two and a half weeks, patients receive three chemotherapy cycles, starting on day 57, 71 and 85, consisting of: Folinic acid: 400 mg/sqm, 2h-iv; Oxaliplatin: 100 mg/sqm, 2h-iv; 5-FU: 2400 mg/sqm, 46h-iv | Drug | Radiochemotherapy -> chemotherapy. |
| Deep regional hyperthermiaDeep regional hyperthermia to the pelvis, total time 90 min, target temperature 41-42°C. Twice weekly, up to a total of 10 sessions within d1 and d38. Deep regional hyperthermia is offered at the centers in Tübingen and Erlangen. | Other | Radiochemotherapy -> chemotherapy. |
Primary outcome
Clinical complete response rate
Time frame: Day 106 after the start of treatment
Response to treatment is assessed on day 106 after the start of radiochemotherapy. A clinical complete response is defined by standardized findings in rectoscopy, MRI and digital rectal examination
13 secondary outcomes
Local regrowth rate
Time frame: 4 years
Safety of the treatment (toxicity assessment according to NCI CTCAE Version 4.0)
Time frame: 4 years
Fecal incontinence according to Wexner-Vaizey Score
Time frame: 4 years
Quality of life according to EORTC Quality of Life questionnaire - C30
Time frame: 4 years
Quality of life according to EORTC Quality of Life questionnaire - CR29
Time frame: 4 years
Frequency of Low anterior resection syndrome (LARS-scale)
Time frame: 4 years
Surgical morbidity in patients undergoing surgery
Time frame: up to 30 days after surgery
Surgical complications in patients undergoing surgery
Time frame: up to 30 days after surgery
Pathological staging, tumor downstaging (assessed by ypTNM findings in relation to initial cTNM staging), tumor regression grading according to Dworak in patients undergoing surgery
Time frame: Day 123 after the start of treatment
R0 resection rate, rate of circumferential resection margin negativity (> 1mm) in patients undergoing surgery
Time frame: Day 123 after the start of treatment
Rate of sphincter-sparing surgery in patients undergoing surgery
Time frame: Day 123 after the start of treatment
Relapse-free survival (local / distant / overall)
Time frame: 4 years
Overall survival
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
- Background: PubMed 29658007Gani C, Bonomo P, Zwirner K, Schroeder C, Menegakis A, Rodel C, Zips D. Organ preservation in rectal cancer - Challenges and future strategies. Clin Transl Radiat Oncol. 2017 Mar 23;3:9-15. doi: 10.1016/j.ctro.2017.02.002. eCollection 2017 Apr.
- Background: PubMed 23006132Schroeder C, Gani C, Lamprecht U, von Weyhern CH, Weinmann M, Bamberg M, Berger B. Pathological complete response and sphincter-sparing surgery after neoadjuvant radiochemotherapy with regional hyperthermia for locally advanced rectal cancer compared with radiochemotherapy alone. Int J Hyperthermia. 2012;28(8):707-14. doi: 10.3109/02656736.2012.722263. Epub 2012 Sep 24.
- Background: PubMed 26189067Rodel C, Graeven U, Fietkau R, Hohenberger W, Hothorn T, Arnold D, Hofheinz RD, Ghadimi M, Wolff HA, Lang-Welzenbach M, Raab HR, Wittekind C, Strobel P, Staib L, Wilhelm M, Grabenbauer GG, Hoffmanns H, Lindemann F, Schlenska-Lange A, Folprecht G, Sauer R, Liersch T; German Rectal Cancer Study Group. Oxaliplatin added to fluorouracil-based preoperative chemoradiotherapy and postoperative chemotherapy of locally advanced rectal cancer (the German CAO/ARO/AIO-04 study): final results of the multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2015 Aug;16(8):979-89. doi: 10.1016/S1470-2045(15)00159-X. Epub 2015 Jul 15.
- Derived from this study: PubMed 42879156Diefenhardt M, Fokas E, Kosmala R, Polat B, Germer CT, Schlenska-Lange A, Kuhnt T, Ghadimi M, Rieken S, Wiegering A, Schwarzbach M, Fleischmann M, Grutzmann R, Ott OJ, Martus P, Konigsrainer A, Zips D, Hofheinz RD, Gani C, Rodel C. Organ Preservation and Quality of Life After Total Neoadjuvant Treatment in Rectal Cancer. JAMA Netw Open. 2026 Oct 1;9(10):e2639063. doi: 10.1001/jamanetworkopen.2026.39063.
- Derived from this study: PubMed 40347958Gani C, Fokas E, Polat B, Ott OJ, Diefenhardt M, Konigsrainer A, Boke S, Kirschniak A, Bachmann R, Wichmann D, Bitzer M, Clasen S, Grosse U, Hoffmann R, Gotz M, Hofheinz RD, Germer E, Germer CT, Fietkau R, Martus P, Zips D, Rodel C. Organ preservation after total neoadjuvant therapy for locally advanced rectal cancer (CAO/ARO/AIO-16): an open-label, multicentre, single-arm, phase 2 trial. Lancet Gastroenterol Hepatol. 2025 Jun;10(6):562-572. doi: 10.1016/S2468-1253(25)00049-4.
- Individual participant dataSharing planned: Undecided
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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.
Cihan Gani, Dr. principal investigator
University Hospital Tuebingen
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiotherapy, Chemotherapy and Deep regional hyperthermia in people with Rectal Cancer and Rectal Neoplasms, run by University Hospital Tuebingen at 4 sites 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 8 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cihan Gani, Dr. (+4970712982165, cihan.gani@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical complete response rate (time frame: Day 106 after the start of treatment). 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 NCT03561142, which also lists 5 linked publications.
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 19 Jun 2018.