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Peritoneal CarcinomatosisPhase 2COMBATACNCT01540344

Combined Anticancer Treatment of Advanced Colon Cancer

A Phase 2 study testing CRS and HIPEC in people with Peritoneal Carcinomatosis and Colorectal Cancer Metastatic, run by University of Regensburg at 7 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The COMBATAC study evaluates the the effect as assessed by progression-free survival (PFS) of perioperative systemic chemotherapy including cetuximab and cytoreductive surgery (CRS) and bidirectional hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with peritoneal carcinomatosis arising from colorectal… Read more about this study

Who is it for?
Ages 18 to 71 years
What is being tested?
CRS and HIPEC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
7 sitesGermany
Study dates
Oct 2010to Oct 2017
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 to 71 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Synchronous or metachronous peritoneal carcinomatosis arising from histologically proven colorectal or appendiceal adenocarcinoma
  • Complete macroscopic cytoreduction (CCR-0/1)
  • Free treatment interval of at least 6 month after the last chemotherapy
  • Age over 18 and below 71 years
  • Good general health status (Karnofsky > 70%, ECOG 0-2)
  • Absence of hematogenous metastasis (lung, bone, brain, > 3 peripheric resectable liver metastases)
Show all 14Show fewer
  • Absence of contraindication for systemic chemotherapy and/or extended surgery
  • Life expectancy greater than 6 months
  • Written informed consent
  • Creatinine clearance > 50 ml/min, serum creatinine ≤ 1.5 x ULN
  • Serum bilirubin ≤ 1.5 x ULN (upper limit of normal), ASAT and ALAT ≤ 2.5 x ULN
  • Platelet count > 100,000 /ml, haemoglobin > 9 g/dl, neutrophile granulocytes ≥ 1,500 /ml, International Normalized Ration (INR) ≤ 2
  • Absence of peripheral neuropathy > grade 1 (CTCAE v4.0)
  • No pregnancy or breast feeding. Adequate contraception in fertile patients.

Who cannot join

  • Incomplete cytoreduction
  • Hematogenous metastasis including irresectable liver metastasis
  • Prior chemotherapy or therapy with EGFR receptor antibody for metastatic disease
  • K-ras mutation
  • Known allergy to murine or chimeric monoclonal antibodies
  • Histology of signet ring carcinoma
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  • Other malignancy than disease under study / second cancer
  • Impaired liver, renal or hematologic function as mentioned above (inclusion criteria)
  • Heart failure NYHA ≥ 2 or significant Coronary Artery Disease
  • Alcohol and/or drug abuse
  • Patients unable or unwilling to comply with the study protocol, treatment or follow-up
  • Patients included in other clinical trials interfering with the present study

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Germany7 sites

  • Charité Campus Mitte, Humboldt-University Berlin

    Berlin, 10117

  • Cologne-Merheim Medical Center, University Witten/Herdecke

    Cologne, 51058

  • Medical Center of the Friedrich-Alexander-University Erlangen- Nürnberg

    Erlangen, 91054

  • University Hospital Regensburg

    Regensburg, 93042

  • St. John of God Hospital Regensburg

    Regensburg, 93049

  • University Hospital, University of Tuebingen

    Tübingen, 72076

  • University Hospital Wuerzburg, Julius-Maximilians University

    Würzburg, 97080

Other trials in Germany

About this study

Official title: Multimodality Treatment Including Pre- and Postoperative Systemic Chemotherapy Plus Cetuximab, Cytoreductive Surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients With Peritoneal Carcinomatosis Arising From Wild Type K-ras Colon Cancer: A Prospective Multicenter Phase II Study.

The COMBATAC study evaluates the the effect as assessed by progression-free survival (PFS) of perioperative systemic chemotherapy including cetuximab and cytoreductive surgery (CRS) and bidirectional hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with peritoneal carcinomatosis arising from colorectal cancer.

Read the detailed description

More than 10% of patients with colorectal cancer (CRC) already show peritoneal carcinomatosis at the time of initial diagnosis and up to 25% of all patients develop peritoneal carcinomatosis during the natural course of their disease as a common sign of tumor progression or recurrence.

The existing data suggests that CRS and HIPEC as an integral part of a multidisciplinary treatment concept may improve long-term survival of selected patients with peritoneal carcinomatosis of colonic origin. Moreover, hyperthermic peritoneal perfusion with oxaliplatin in combination with synchronous application of 5-FU/leucovorin seems to improve the efficacy of HIPEC in comparison to a mitomycin C-based intraperitoneal treatment regimen and may lead to a better local tumor control. The improved systemic treatment strategy with neoadjuvant chemotherapy may lead to increased rates of complete macroscopic cytoreduction and together with the adjuvant treatment to better control of distant metastasis and tumor recurrence. However, there is no prospective study available evaluating the clinical and oncological outcome after standard-of-care chemotherapy including targeted anticancer therapy in combination with CRS and HIPEC. The published morbidity and mortality rates after CRS and HIPEC are comparable to other major gastrointestinal surgery and seem to be acceptable considering the expected improvement of oncological outcome.

Being tested
CRS, HIPEC
Keywords
peritoneal carcinomatosis, cytoreductive surgery, HIPEC, colorectal cancer
Medical subject headings
Peritoneal Neoplasms, Colorectal Neoplasms

What participants receive

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

  • CRSProcedure or surgery

    Also called Cytoreductive surgery

    complete macroscopic cytoreduction (CC-0/1)

  • HIPECDrug

    Also called Hyperthermic intraperitoneal chemotherapy

    bidirectional hyperthermic intraperitoneal chemotherapy (HIPEC) with 400 mg/sqm 5-FU + 20 mg/sqm folinic acid IV and 300 mg/sqm oxaliplatin IP

Study groups in NCT01540344
Study groupRoleWhat they receive
Treatment ArmExperimental1. FOLFOX/FOLFIRI + cetuximab (6 cycles) 2. CRS and HIPEC 3. FOLFOX/FOLFIRI + cetuximab (6 cycles)
Receives: Procedure: CRS; Drug: HIPEC

What is being measured

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

  1. Progression-free survival (PFS)

    Measured: 24 months

Secondary outcomes (4)

  1. Overall survival (OS)

    Measured: 5 years

  2. Feasibility of the combined treatment concept

    Assessment of tumor progression, AE and SAE during treatment phase leading to modification or end of treatment.

    Measured: 9 months

  3. Quality of life (QoL)

    assessed by EORTC-QLQ-C30

    Measured: 2 years

  4. Pathohistological regression

    assessed by Dworak grade of regression in histology after surgery

    Measured: 16 weeks

Timeline

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

  1. First posted28 Feb 2012 (estimated)
  2. Study startOct 2010
  3. Primary completionSep 2015
  4. Study completionOct 2017

Why it stopped: Slow recruitment.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01540344
Sponsor's protocol ID
24/06/2009
Other IDs
2009-014040-11, 2009
Acronym
COMBATAC
Status last verified
Aug 2018
First submitted
19 Feb 2012
Last updated
5 Sep 2018
Results posted
No
Data monitoring committee
No

Publications

  • Glockzin G, Rochon J, Arnold D, Lang SA, Klebl F, Zeman F, Koller M, Schlitt HJ, Piso P. A prospective multicenter phase II study evaluating multimodality treatment of patients with peritoneal carcinomatosis arising from appendiceal and colorectal cancer: the COMBATAC trial. BMC Cancer. 2013 Feb 7;13:67. doi: 10.1186/1471-2407-13-67.

    PubMed 23391248

  • Glockzin G, Zeman F, Croner RS, Konigsrainer A, Pelz J, Strohlein MA, Rau B, Arnold D, Koller M, Schlitt HJ, Piso P. Perioperative Systemic Chemotherapy, Cytoreductive Surgery, and Hyperthermic Intraperitoneal Chemotherapy in Patients With Colorectal Peritoneal Metastasis: Results of the Prospective Multicenter Phase 2 COMBATAC Trial. Clin Colorectal Cancer. 2018 Dec;17(4):285-296. doi: 10.1016/j.clcc.2018.07.011. Epub 2018 Jul 31.

    PubMed 30131226

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CRS and HIPEC in people with Peritoneal Carcinomatosis and Colorectal Cancer Metastatic, run by University of Regensburg at 7 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 14 inclusion and 12 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 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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?

The study was stopped early (reason given: Slow recruitment.). 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?

Progression-free survival (PFS) (time frame: 24 months). 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 NCT01540344, which also lists 2 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 5 Sep 2018.

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