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Colorectal Peritoneal CarcinomatosisPhase 3NCT01524094

Cytoreduction and Intraperitoneal Chemotherapy Versus Systemic Chemotherapy in Colorectal Peritoneal Carcinomatosis

A Phase 3 study testing Systemic chemotherapy alone (oxaliplatin, 5-fluorouracil, isovorin) and Cytoreductive surgery (CRS) plus postoperative intraperitoneal chemotherapy (5-fluorouracil, isovorin) in people with Colorectal Peritoneal Carcinomatosis, run by Uppsala University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to see if there is a difference in survival between two different treatment strategies for colorectal peritoneal surface disease. The control arm administered the currently considered standard treatment which is palliative systemic chemotherapy. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Colorectal Peritoneal Carcinomatosis
What is being tested?
Systemic chemotherapy alone (oxaliplatin, 5-fluorouracil, isovorin) and Cytoreductive surgery (CRS) plus postoperative intraperitoneal chemotherapy (5-fluorouracil, isovorin)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
1 siteSweden
Study dates
Jun 2003to Jan 2012
Phase
Phase 3
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Metastatic disease to the peritoneum from colon or rectum (at least two isolated sites of disease)
  • verified primary tumor of adenocarcinoma of the colon or rectum
  • Potential resectability as judged by the treating surgeon
  • Patient is available for follow-up according to the study protocol
  • Signed informed consent

Who cannot join

  • Extraabdominal metastases or liver metastases
  • Paraaortic or other inoperable lymph node metastases
  • Clear indication for surgery only (such as obstruction, bleeding or peritonitis)
  • Prior treatment of either arm in the study
  • Clinical or histopathological diagnosis of Peritoneal Pseudomyxoma
  • Age > 80
Show all 9Show fewer
  • Contraindications for chemotherapy
  • Pregnancy or breastfeeding
  • Ongoing infection

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Akademiska Sjukhuset (Uppsala University Hospital)

    Uppsala, SE-751 85

Other trials in Sweden

About this study

Official title: A Randomised Phase-III Study Comparing Cytoreductive Surgery Plus Intraperitoneal Chemotherapy Versus Modern Systemic Chemotherapy in Colorectal Peritoneal Carcinomatosis.

The purpose of this study is to see if there is a difference in survival between two different treatment strategies for colorectal peritoneal surface disease. The control arm administered the currently considered standard treatment which is palliative systemic chemotherapy. The experimental arm received the combination treatment cytoreductive surgery and intraperitoneal chemotherapy. The investigators hypothesis is that the combination treatment will improve the overall survival.

Being tested
Systemic chemotherapy alone (oxaliplatin, 5-fluorouracil, isovorin), Cytoreductive surgery (CRS) plus postoperative intraperitoneal chemotherapy (5-fluorouracil, isovorin)
Keywords
colorectal cancer, cytoreductive surgery, intraperitoneal chemotherapy, systemic chemotherapy, Peritoneal Metastatic Disease From the Colon or Rectum
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • Systemic chemotherapy alone (oxaliplatin, 5-fluorouracil, isovorin)Drug

    Oxaliplatin 100 mg/ m2 as a 2 h iv infusion + 5-fluorouracil 400 mg/ m2 iv bolus + Isovorin 100 mg/ m2 as a 2 h infusion followed by 5-fluorouracil 2400 mg/ m2 as a 46 h infusion. Each cycle is given every other week until 12 cycles have been administered.

  • Cytoreductive surgery (CRS) plus postoperative intraperitoneal chemotherapy (5-fluorouracil, isovorin)Procedure or surgery

    Cytoreductive surgery has the goal of completely resecting all visible tumor tissue in the abdomen. Sequential postoperative intraperitoneal chemotherapy has the purpose of an adjuvant treatment to eradicate microscopic residual tumor and prevent recurrences in the abdomen. The chemotherapy regimen consisted of intraperitoneal 5-fluorouracil 550 mg/ m2 and intravenous isovorin 30 mg/ m2 day 1-6 med cycles every 4-6 weeks. Six cycles were planned.

Study groups in NCT01524094
Study groupRoleWhat they receive
Arm A: CRS plus postop intraperitoneal chemotherapy.ExperimentalCytoreductive surgery and postoperative intraperitoneal chemotherapy.
Receives: Procedure: Cytoreductive surgery (CRS) plus postoperative intraperitoneal chemotherapy (5-fluorouracil, isovorin)
Arm B: Systemic chemotherapy aloneActive comparatorSystemic chemotherapy alone
Receives: Drug: Systemic chemotherapy alone (oxaliplatin, 5-fluorouracil, isovorin)

What is being measured

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

  1. Overall survival

    Measured: 8 years

Secondary outcomes (6)

  1. progression free survival

    Measured: 8 years

  2. Time to secondary treatment

    Measured: 8 years

  3. Radical resectability

    Measured: 5 years

  4. Quality of life

    Measured: 7 years

  5. Health costs

    Measured: 8 years

  6. Side effects of treatment

    Measured: 6 years

Timeline

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

  1. First posted1 Feb 2012 (estimated)
  2. Study startJun 2003
  3. Primary completionDec 2010
  4. Study completionJan 2012

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01524094
Sponsor's protocol ID
SPS-1
Status last verified
Jan 2012
First submitted
18 Jan 2012
Last updated
1 Feb 2012
Results posted
No
Data monitoring committee
No

Publications

  • Verwaal VJ, van Ruth S, de Bree E, van Sloothen GW, van Tinteren H, Boot H, Zoetmulder FA. Randomized trial of cytoreduction and hyperthermic intraperitoneal chemotherapy versus systemic chemotherapy and palliative surgery in patients with peritoneal carcinomatosis of colorectal cancer. J Clin Oncol. 2003 Oct 15;21(20):3737-43. doi: 10.1200/JCO.2003.04.187.

    PubMed 14551293

  • Assersohn L, Norman A, Cunningham D, Benepal T, Ross PJ, Oates J. Influence of metastatic site as an additional predictor for response and outcome in advanced colorectal carcinoma. Br J Cancer. 1999 Apr;79(11-12):1800-5. doi: 10.1038/sj.bjc.6690287.

    PubMed 10206296

  • Shepherd NA, Baxter KJ, Love SB. The prognostic importance of peritoneal involvement in colonic cancer: a prospective evaluation. Gastroenterology. 1997 Apr;112(4):1096-102. doi: 10.1016/s0016-5085(97)70119-7.

    PubMed 9097991

  • Graf W, Glimelius B, Pahlman L, Bergstrom R. Determinants of prognosis in advanced colorectal cancer. Eur J Cancer. 1991;27(9):1119-23. doi: 10.1016/0277-5379(91)90307-y.

    PubMed 1835620

  • Elias D, Blot F, El Otmany A, Antoun S, Lasser P, Boige V, Rougier P, Ducreux M. Curative treatment of peritoneal carcinomatosis arising from colorectal cancer by complete resection and intraperitoneal chemotherapy. Cancer. 2001 Jul 1;92(1):71-6. doi: 10.1002/1097-0142(20010701)92:13.0.co;2-9.

    PubMed 11443611

  • Saltz LB, Cox JV, Blanke C, Rosen LS, Fehrenbacher L, Moore MJ, Maroun JA, Ackland SP, Locker PK, Pirotta N, Elfring GL, Miller LL. Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group. N Engl J Med. 2000 Sep 28;343(13):905-14. doi: 10.1056/NEJM200009283431302.

    PubMed 11006366

  • Cashin PH, Mahteme H, Spang N, Syk I, Frodin JE, Torkzad M, Glimelius B, Graf W. Cytoreductive surgery and intraperitoneal chemotherapy versus systemic chemotherapy for colorectal peritoneal metastases: A randomised trial. Eur J Cancer. 2016 Jan;53:155-62. doi: 10.1016/j.ejca.2015.09.017. Epub 2016 Jan 2.

    PubMed 26751236

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Systemic chemotherapy alone (oxaliplatin, 5-fluorouracil, isovorin) and Cytoreductive surgery (CRS) plus postoperative intraperitoneal chemotherapy (5-fluorouracil, isovorin) in people with Colorectal Peritoneal Carcinomatosis, run by Uppsala University at 1 site in Sweden.

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 5 inclusion and 9 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: finished, as of the sponsor's last update on 1 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Overall survival (time frame: 8 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 NCT01524094, which also lists 7 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 1 Feb 2012.

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