Sarcoma, Soft TissueCOLOSARC-QNCT06943612
Colorectal Resections in Patients With Retroperitoneal Sarcoma
An observational study of Sarcoma, Soft Tissue and Retroperitoneal Sarcoma, run by Heidelberg University at 16 sites in 2 countries.
Trial summary
COLOSARC-Q is a multicenter study with the objective of providing an up-to-date assessment of colorectal resections and reconstruction techniques in the context of multivisceral resections for retroperitoneal sarcomas, as well as colorectal surgery-associated complications and their impact on patients' quality of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma, Soft Tissue, Retroperitoneal Sarcoma
- How many people
- 120 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 27 Jan 2025to 5 Nov 2026
- Phase
- Observational
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
Study population: Patients with primary, retroperitoneal sarcomas who underwent surgery with colorectal resection at DKG-certified sarcoma centers or hospitals in Germany and Switzerland that meet certification-equivalent criteria.
Who may be able to join
- Histological confirmation with evidence of a retroperitoneal sarcoma
- Tumor resection with colorectal resection
- Surgery in a DKG-certified sarcoma center or hospital that meets certification-equivalent criteria
- Age 18 years or older
- Written consent
Who cannot join
- Absence of consent
Trial locations and contacts
16 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Madelaine Hettler, Dr. contact
16 sites in 2 countries
Germany15 sites, 15 recruiting
- Recruiting
Helios Hospital Berlin-Buch
Berlin
Marcus Steinbach, 0049 (030) 94 01-0, info.berlin-buch@helios-gesundheit.de
- Recruiting
University Hospital Koeln
Cologne
Lars Schiffmann, MD, +49 (0) 221 478-4824, cio-sarkom@uk-koeln.de
- Recruiting
University Medical Center Dresden
Dresden
Johanna Kirchberg, 0049(0)351 458-4500, sarkome@ukdd.de
- Recruiting
University Medical Center Erlangen
Erlangen
Katja Fechner, 0049 9131 85-33368, sarkomzentrum@uk-erlangen.de
- Recruiting
University Medical Center Goettingen
Göttingen, Deutschland, 37075
Florian Bösch, MD, +49 (0)551 3965303, zentrum.sarkome@med.uni-goettingen.de
- Recruiting
University Medical Center Greifswald
Greifswald
+49(0)3834/866065, Alexandra.Busemann@med.uni-greifswald.de
Alexandra Busemann, MD
- Recruiting
University Medical Center Halle
Halle
Ulrich Ronellenfitsch, Prof., +49 345 557 2143
- Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg
Anna Duprée, Dr., +49 (0) 40 - 7410 - 55692
- Recruiting
Medical University of Hannover
Hanover
Ulrich Zwirner, Dr., +49 511532 2032
- Recruiting
Heidelberg University Hospital
Heidelberg
Cosima Engerer, Dr., +49 6221 483713
- Recruiting
University Hospital Magdeburg
Magdeburg
Roland S Croner, Prof., +49 391 67-15500
- Recruiting
Sarcoma Center of University Medical Center Mannheim
Mannheim, Baden-Wurttemberg, 68167
Jens Jakob, Prof., +49 621 383 2447, Jens.Jakob@umm.de
- Recruiting
LMU Hospital
München
Markus Albertsmeier, Dr., +49 (0)89 4400 74798
- Recruiting
University Medical Center Tübingen
Tübingen
Christoph Deinzer, 0049 7071 29-86483, sarkome@med.uni-tuebingen.de
- Recruiting
University Medical Center Ulm
Ulm
Nuh Rahbrai, 0049 (0) 731 500-56056, sekr.cccu@uniklinik- ulm.de
Switzerland1 site, 1 recruiting
- Recruiting
Sarcoma Center University of Basel
Basel
Alexander Willhelm, Dr., +41 61 777 73 17
About this study
Official title: Colorectal Resections and Reconstructions in Patients With Retroperitoneal Sarcoma: Evaluation of Surgical Strategies and Postoperative Quality of Life
COLOSARC-Q is a multicenter study with the objective of providing an up-to-date assessment of colorectal resections and reconstruction techniques in the context of multivisceral resections for retroperitoneal sarcomas, as well as colorectal surgery-associated complications and their impact on patients' quality of life.
In multivisceral resections involving the colon and rectum, the primary aim is to achieve complete resection and preserve organ function. However, multivisceral resections have a high risk of perioperative morbidity including anastomotic leakage. The proposed project aims to determine the number of primary anastomoses, their insufficiency rates, and the fraction of patients with primary and secondary stomas. In addition, the patients' quality of life after multivisceral sarcoma resection is to be recorded using standardized surveys.
The analysis has the potential to facilitate intraoperative decision-making for colorectal resections in the context of multivisceral resections.
Read the detailed description
The primary goal of retroperitoneal sarcoma surgery is to achieve complete resection. The resection of retroperitoneal sarcomas (RPS) usually involves the removal of parts of the colon. While there is good data on surgical principles and postoperative complications of multivisceral resections in RPS as a whole (1, 2), there is little evidence on the frequency of temporary or permanent stomas and complications associated with intestinal surgery (e.g., number of anastomotic leackages in relation to the number of intestinal anastomoses performed) and their impact on the quality of life of those affected.
The COLOSARC-Q study is a multicenter, non-interventional study with the aim of documenting
- colorectal resection and reconstruction techniques in connection with multivisceral resections in retroperitoneal sarcomas (RPS),
- complications associated with intestinal surgery in multivisceral resections, and
- the resulting effects on the quality of life of sarcoma patients. The project plans to include 120 patients with retroperitoneal sarcomas who have undergone colon resection as part of a multivisceral resection at a DKG-certified sarcoma center or hospital that meets certification-equivalent criteria. For these patients, patient-, tumor-, and treatment-specific parameters (all patients), standardized questionnaires on health-related quality of life (EORTC QLQ - C30 (version 3.0)) and bowel function (EORTC QLQ - CR29) (expected response rate ≥ 50%) and semi-structured interviews with the aim of recording specific problems that may not be covered in the questionnaires (e.g., regarding stoma placement, nutritional status, treatment sequence, or home care; n = 10-15).
COLOSARC-Q has the potential to improve preoperative participatory decision-making and intraoperative strategy in colorectal resections as part of multivisceral resections in order to reduce complication rates and develop surgical strategies tailored to specific patient needs.
- Conditions
- Sarcoma, Soft Tissue, Retroperitoneal Sarcoma
- Keywords
- Soft tissue sarcoma, Retroperitoneal Sarcoma, Sarcoma Surgery, Stoma, Colorectal resection
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with primary, retroperitoneal sarcomas who underwent surgery with colorectal resection | Patients with primary retroperitoneal sarcomas who underwent surgery with colorectal resection at DKG-certified sarcoma centers or hospitals in Germany and Switzerland that meet certification-equivalent criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of resection and reconstruction procedures of the colon and rectum in the context of multivisceral resections of retroperitoneal sarcomas
Description of the surgical procedure, e.g. righ hemicolectomy with primary anastomosis
Measured: immediately after the surgery
Secondary outcomes (5)
Postoperative complications associated with resections and reconstructions of the bowel
Evaluation of postoperative complications associated with resections and reconstructions of the bowel during and after multivisceral resections of retroperitoneal sarcomas (Comprehensive Complication Index (CCI), up to 90 days postoperatively)
Measured: up to 90 days after surgery
Assessment of quality of life after colorectal resections in the context of RPS resections
Assessment of quality of life after using the EORTC QLQ - C30 (Version 3.0) questionnaires)
Measured: through study completion, an average of 1 year
Assessment of changes in bowel function after resection of retroperitoneal sarcomas
Assessment of the bowel function using the EORTC QLQ - CR29 questionnaire
Measured: through study completion, an average of 1 year
Identification of problems and needs of RPS patients
Identification of problems and needs of RPS patients who have undergone resection and reconstruction of the colon, e.g. with regard to education, home care, bowel function, stoma care, rehabilitation measures and therapy intensity and sequence
Measured: through study completion, an average of 1 year
Determination of patient-, tumor- and treatment-related factors influencing the above-mentioned primary and secondary study objectives
Determination of the influence of the following patient-, tumor- and treatment-related factors on the above-mentioned primary and secondary study objectives:
- Gender
- age
- Body mass index (BMI)
- Malnutrition (serum albumin preoperatively)
- Concomitant diseases (e.g. diabetes mellitus, coronary heart disease)
- Previous abdominal surgery
- Size, localization (left/right), grading and histological subtype of the RPS
- Neoadjuvant therapies (radiotherapy and/or chemotherapy)
- Operation time
- Intraoperative blood loss
- Extent of the surgical procedure
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start27 Jan 2025
- Primary completion29 Jun 2026
- Study completion5 Nov 2026 (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 Sarcoma, Soft TissueStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jens Jakob, MD, Heidelberg University
- Investigators
- Jens Jakob, Prof., Principal investigator, Sarcoma Unit, Department of Surgery, University Medical Center Mannheim, Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06943612
- Sponsor's protocol ID
- 2024-562
- Other IDs
- DRKS00034135
- Acronym
- COLOSARC-Q
- Status last verified
- Jul 2026
- First submitted
- 10 Apr 2025
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jakob J, Hentschel L, Richter S, Kreisel I, Hohenberger P, Kasper B, Andreou D, Pink D, Schmitt J, Schuler MK, Eichler M. Transferability of Health-Related Quality of Life Data of Large Observational Studies to Clinical Practice: Comparing Retroperitoneal Sarcoma Patients from the PROSa Study to a TARPS-WG Cohort. Oncol Res Treat. 2022;45(11):660-669. doi: 10.1159/000525288. Epub 2022 Jun 14.
PubMed 35700716MacNeill AJ, Fiore M. Surgical morbidity in retroperitoneal sarcoma resection. J Surg Oncol. 2018 Jan;117(1):56-61. doi: 10.1002/jso.24902. Epub 2018 Jan 3.
PubMed 29314041Bonvalot S, Raut CP, Pollock RE, Rutkowski P, Strauss DC, Hayes AJ, Van Coevorden F, Fiore M, Stoeckle E, Hohenberger P, Gronchi A. Technical considerations in surgery for retroperitoneal sarcomas: position paper from E-Surge, a master class in sarcoma surgery, and EORTC-STBSG. Ann Surg Oncol. 2012 Sep;19(9):2981-91. doi: 10.1245/s10434-012-2342-2. Epub 2012 Apr 3.
PubMed 22476756Gronchi A, Strauss DC, Miceli R, Bonvalot S, Swallow CJ, Hohenberger P, Van Coevorden F, Rutkowski P, Callegaro D, Hayes AJ, Honore C, Fairweather M, Cannell A, Jakob J, Haas RL, Szacht M, Fiore M, Casali PG, Pollock RE, Raut CP. Variability in Patterns of Recurrence After Resection of Primary Retroperitoneal Sarcoma (RPS): A Report on 1007 Patients From the Multi-institutional Collaborative RPS Working Group. Ann Surg. 2016 May;263(5):1002-9. doi: 10.1097/SLA.0000000000001447.
PubMed 26727100Hettler M, Scharpf KR, Eich A, Albertsmeier M, Dupree A, Hetjens S, Harbrucker M, Menge F, Betzler A, Hohenberger P, Jakob J. Multicentre prospective non-interventional study protocol for evaluating surgical strategies for Colorectal Resections and Postoperative Quality of Life in Retroperitoneal Sarcoma Patients Across German-Speaking Sarcoma Centres (COLOSARC-Q). BMJ Open. 2025 Dec 30;15(12):e102015. doi: 10.1136/bmjopen-2025-102015.
PubMed 41469069