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Colonic CancerPhase 4CCRe-IVNCT02015923

Resection vs no Resection of the Primary in Colorectal Cancer With Unresectable Metastases

A Phase 4 study testing Colonic resection and Chemotherapy- scheme in people with Colonic Cancer and Unresectable Metastasis Originating in Colonic Cancer, run by Hospital Universitari de Bellvitge at 22 sites in Spain.

Terminated

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

Official record
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Trial summary

Main outcome: Assess the impact of cancer-related survival at 2 years in patients with unresectable metastatic colorectal cancer treated with chemotherapy alone versus surgery followed by chemotherapy. To assess overall survival. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Colonic resection and Chemotherapy- scheme
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
107 participants
Where
22 sitesSpain
Study dates
Dec 2013to Feb 2020
Phase
Phase 4
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

  • colorectal cancer above to 12 cm from the anal verge
  • unresectable synchronous metastases
  • no contraindications for chemotherapy
  • absence of peritoneal carcinomatosis, central nervous system o bone metastasis.
  • performance status ECOG ≤ 2 (Eastern Cooperative Oncology Group)
  • uncontrolled concomitant medical conditions that may compromise to chemotherapy
  • significant symptomatic cardiac disease
  • not pregnancy or breastfeeding

Who cannot join

  • Cases of rectal tumours below 12cm from anal verge, or locally advanced tumours invading blood vessels, nerves or bone.
  • Multiple bone metastasis or central nervous system metastasis
  • Other neoplastic disease in the 5 previous years, except squamous or basal cell skin carcinoma or cervical "in situ" carcinoma
  • Significant heart disease (chronic congestive heart failure, symptomatic coronary disease) or myocardial infarction in the previous 6 months
  • Peripheral neuropathy
  • Patients who do not give informed consent

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

Spain22 sites

  • Complejo Hospitalario La Mancha Centro

    Alcázar de San Juan, Ciudad Real

  • Complejo Hospitalario Torrecárdenas

    Almería

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona

  • Hospital de la Santa Creu i Sant Pau

    Barcelona

  • Hospital del Mar

    Barcelona

  • Hospital Univesitari Vall d'Hebron

    Barcelona

  • Hospital Universitario Donostia

    Donostia / San Sebastian

  • Hospital Universitari de Girona DrJosep Trueta

    Girona

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08709

  • Hospital Univerisitario La Paz

    Madrid

  • Hospital Clínico Universitario Virgen de la Arrixaca

    Murcia

  • Complejo Hospitalario Universitario de Orense

    Ourense

  • Complejo Hospitalario de Navarra

    Pamplona, Navarre

  • Corporació Sanitària Parc Taulí

    Sabadell, Barcelona

  • Hospital Moisès Broggi

    Sant Joan Despí, Barcelona

  • Hospital Universitario Virgen del Rocío

    Seville

  • Hospital Clínico Universitario de Valencia

    Valencia

  • Hospital General de Valencia

    Valencia

  • Hospital Universitari i Politècnic la Fe

    Valencia

  • Complejo Hospitalario Universitario de Vigo

    Vigo, Pontevedra

  • Hospital Universitario Araba

    Vitoria-Gasteiz, Araba

  • Hospital Clínico Univeristario "Lozano Blesa"

    Zaragoza

Other trials in Spain

About this study

Official title: Multicenter Randomized Study in Patients With Colorectal Cancer With Unresectable Metastases. Impact of Resection vs no Resection of the Primary Tumour as a Survival Factor

Main outcome: Assess the impact of cancer-related survival at 2 years in patients with unresectable metastatic colorectal cancer treated with chemotherapy alone versus surgery followed by chemotherapy. To assess overall survival. To evaluate postoperative morbidity and mortality in patients treated with resection of the primary tumor. Assess complications and meed for surgery in patients treated with systemic chemotherapy only during the course of the disease. Identify and describe the complications related to chemotherapy and toxicity in the short and medium term systemic treatment. Assessing the quality of life questionnaire QLQ-C30 and QLQ-CR29. To study prognostic survival factors.

Method: multicenter randomized clinical trail (22 hospitals). Two parallel group in which to evaluate two therapeutic strategies for colorectal cancer metastasis unresectable stage IV: chemotherapy alone versus primary tumor resection plus chemotherapy.

Subjects: patients with unresectable nonmetastatic colorectal cancer. Hypothesis:Surgical resection of the primary tumor in stage IV colorectal patients with unresectable synchronous metastases increases by 14% overall survival compared to patients receiving systemic treatment with chemotherapy without resection of the primary tumor (survival of 34% vs 20%).

Read the detailed description

Intervention: Arm B (control): chemotherapy alone, regimen according to each center. Arm A (experimental): surgery (complete tumoral resection; R0) followed by chemotherapy, regimen according to each center. Statistical Analysis: A power analysis showed that to assure a significance level of 0,05 and a beta error 0.20. 168 patients are necessary in each arm. It has been estimated a loss rate of up to 10%.

Differences between groups will be analyzed by t, U, X2, exact test and survival will be assessed according to Kaplan and Meier method. Evaluation of safety of the trial will be made in the middle of the study statistically

Being tested
Colonic resection, Chemotherapy- scheme
Keywords
Colonic cancer, Metastasis
Medical subject headings
Colonic Neoplasms, Neoplasm Metastasis

What participants receive

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

  • Colonic resectionProcedure or surgery

    Colonic cancer resection, R0 No surgical intervention on metastasis

  • Chemotherapy- schemeDrug

    Also called FOLFOX-4, FOLFOX-6, FOLFIRI, FOLFOXIRI

    Chemotherapy, specified in each center with or without biological drugs

Study groups in NCT02015923
Study groupRoleWhat they receive
colonic resectionExperimentalArm A (experimental): surgery (complete tumoral resection; R0) followed by chemotherapy, regimen according to each center.
Receives: Procedure: Colonic resection; Drug: Chemotherapy- scheme
ChemotherapyActive comparatorArm B (control): chemotherapy alone, regimen according to each center
Receives: Procedure: Colonic resection; Drug: Chemotherapy- scheme

What is being measured

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

  1. Assess the impact of overall survival in patients with unresectable metastatic colorectal cancer treated with chemotherapy alone vs surgery followed by chemotherapy.

    The percentage of patients who are still alive for follow-up at 2 years after randomization.

    Measured: up to 2 years

Secondary outcomes (4)

  1. Postoperative morbidity and mortality.

    Postoperative complications were classified according to the Dindo-Clavien classification.

    Mortality within 30 days after surgery

    Measured: 30 days postoperatively

  2. Complications in patients treated with systemic chemotherapy

    The toxicity will be evaluated and documented according to the CTCAE version 4.0.

    Measured: up to 2 years

  3. Questionnaire Quality of life CR29

    Specific questionnaire for colon cancer

    Measured: up to 2 years

  4. Study of possible survival factors

    Identify factors that may influence patient survival before applying any treatment (demographics, clinicals and analitycal factors, tumor characteristics; ...)

    Measured: up to 2 years

Timeline

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

  1. First posted19 Dec 2013 (estimated)
  2. Study startDec 2013
  3. Primary completionJun 2019
  4. Study completionFeb 2020

Why it stopped: Difficulties surrounding recruiting patients

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 4
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
107 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02015923
Sponsor's protocol ID
01CCRe-IV
Other IDs
2013-001688-22
Acronym
CCRe-IV
Status last verified
Mar 2021
First submitted
28 Nov 2013
Last updated
16 Mar 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Rahbari NN, Biondo S, Frago R, Feisst M, Kreisler E, Rossion I, Serrano M, Jager D, Lehmann M, Sommer F, Dignass A, Bolling C, Vogel I, Bork U, Buchler MW, Folprecht G, Kieser M, Lordick F, Weitz J; SYNCHRONOUS and CCRe-IV Trial Groups. Primary Tumor Resection Before Systemic Therapy in Patients With Colon Cancer and Unresectable Metastases: Combined Results of the SYNCHRONOUS and CCRe-IV Trials. J Clin Oncol. 2024 May 1;42(13):1531-1541. doi: 10.1200/JCO.23.01540. Epub 2024 Feb 27.

    PubMed 38412408

  • Biondo S, Frago R, Kreisler E, Espin-Basany E; Spanish CR4 Group. Impact of resection versus no resection of the primary tumor on survival in patients with colorectal cancer and synchronous unresectable metastases: protocol for a randomized multicenter study (CR4). Int J Colorectal Dis. 2017 Jul;32(7):1085-1090. doi: 10.1007/s00384-017-2827-3. Epub 2017 May 11.

    PubMed 28497402

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Colonic resection and Chemotherapy- scheme in people with Colonic Cancer and Unresectable Metastasis Originating in Colonic Cancer, run by Hospital Universitari de Bellvitge at 22 sites in Spain.

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 6 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 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Spain. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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: Difficulties surrounding recruiting patients). 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?

Assess the impact of overall survival in patients with unresectable metastatic colorectal cancer treated with chemotherapy alone vs surgery followed by chemotherapy. (time frame: up to 2 years). 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 NCT02015923, 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 16 Mar 2021.

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