Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 3:36 AM
Study NCT ID:
NCT01524094
Status:
COMPLETED
Last Update Posted:
2012-02-01
First Post:
2012-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cytoreduction and Intraperitoneal Chemotherapy Versus Systemic Chemotherapy in Colorectal Peritoneal Carcinomatosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D065426', 'term': 'Cytoreduction Surgical Procedures'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-31', 'studyFirstSubmitDate': '2012-01-18', 'studyFirstSubmitQcDate': '2012-01-31', 'lastUpdatePostDateStruct': {'date': '2012-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '8 years'}], 'secondaryOutcomes': [{'measure': 'progression free survival', 'timeFrame': '8 years'}, {'measure': 'Time to secondary treatment', 'timeFrame': '8 years'}, {'measure': 'Radical resectability', 'timeFrame': '5 years'}, {'measure': 'Quality of life', 'timeFrame': '7 years'}, {'measure': 'Health costs', 'timeFrame': '8 years'}, {'measure': 'Side effects of treatment', 'timeFrame': '6 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['colorectal cancer', 'cytoreductive surgery', 'intraperitoneal chemotherapy', 'systemic chemotherapy', 'Peritoneal Metastatic Disease From the Colon or Rectum'], 'conditions': ['Colorectal Peritoneal Carcinomatosis']}, 'referencesModule': {'references': [{'pmid': '14551293', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '10206296', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '9097991', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '1835620', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '11443611', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '11006366', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26751236', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Metastatic disease to the peritoneum from colon or rectum (at least two isolated sites of disease)\n* verified primary tumor of adenocarcinoma of the colon or rectum\n* Potential resectability as judged by the treating surgeon\n* Patient is available for follow-up according to the study protocol\n* Signed informed consent\n\nExclusion Criteria:\n\n* Extraabdominal metastases or liver metastases\n* Paraaortic or other inoperable lymph node metastases\n* Clear indication for surgery only (such as obstruction, bleeding or peritonitis)\n* Prior treatment of either arm in the study\n* Clinical or histopathological diagnosis of Peritoneal Pseudomyxoma\n* Age \\> 80\n* Contraindications for chemotherapy\n* Pregnancy or breastfeeding\n* Ongoing infection'}, 'identificationModule': {'nctId': 'NCT01524094', 'briefTitle': 'Cytoreduction and Intraperitoneal Chemotherapy Versus Systemic Chemotherapy in Colorectal Peritoneal Carcinomatosis', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'A Randomised Phase-III Study Comparing Cytoreductive Surgery Plus Intraperitoneal Chemotherapy Versus Modern Systemic Chemotherapy in Colorectal Peritoneal Carcinomatosis.', 'orgStudyIdInfo': {'id': 'SPS-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: CRS plus postop intraperitoneal chemotherapy.', 'description': 'Cytoreductive surgery and postoperative intraperitoneal chemotherapy.', 'interventionNames': ['Procedure: Cytoreductive surgery (CRS) plus postoperative intraperitoneal chemotherapy (5-fluorouracil, isovorin)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm B: Systemic chemotherapy alone', 'description': 'Systemic chemotherapy alone', 'interventionNames': ['Drug: Systemic chemotherapy alone (oxaliplatin, 5-fluorouracil, isovorin)']}], 'interventions': [{'name': 'Systemic chemotherapy alone (oxaliplatin, 5-fluorouracil, isovorin)', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Arm B: Systemic chemotherapy alone']}, {'name': 'Cytoreductive surgery (CRS) plus postoperative intraperitoneal chemotherapy (5-fluorouracil, isovorin)', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Arm A: CRS plus postop intraperitoneal chemotherapy.']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE-751 85', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Akademiska Sjukhuset (Uppsala University Hospital)', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Wilhelm Graf, M.D. Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uppsala University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., PhD.', 'investigatorFullName': 'Wilhelm Graf, M.D., Ph.D.', 'investigatorAffiliation': 'Uppsala University'}}}}