Modulation of Adjuvant 5-FU by Folinic Acid and Interferon-alpha in Colon Cancer - Full Text View

Purpose

The primary objective was to improve adjuvant 5-FU chemoradiotherapy in resectable rectal cancer. The investigators hypothesis was that modulation of 5-FU by addition of either FA or INF-alpha may increase overall survival.

Condition	Intervention	Phase
Rectal Cancer	Drug: Folinic Acid, interferon-alpha	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase 3 Study of Adjuvant Chemoradiotherapy of Advanced Resectable Rectal Cancer Comparing Modulation of 5-FU With Folinic Acid or With Interferon-alpha

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Fluorouracil Folic acid Leucovorin calcium Interferon Levoleucovorin Interferon Alfa-2a

U.S. FDA Resources

Further study details as provided by University of Ulm:

Primary Outcome Measures:

overall survival [ Time Frame: 5-year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

recurrence-free survival [ Time Frame: 5-year ] [ Designated as safety issue: No ]
Toxicity (WHO) [ Time Frame: 5-year ] [ Designated as safety issue: Yes ]

Enrollment:	796
Study Start Date:	July 1992
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 5-FU Standard arm Systemic drug administration of 5-FU (intravenous)	Drug: Folinic Acid, interferon-alpha 5-FU, 450 mg/m² i.v. for 60 min, weekly for 52 weeks postoperatively Folinic acid, 200 mg/m² i.v. 10 min, weekly for 52 weeks postoperatively 6x10 (high6) I.U. as subcutaneous self injection 3x weekly. Training of self injection was initiated on day 28 (duration until week 52)
Experimental: 5-FU + folinic acid Experimental arm Systemic drug administration of 5-FU + folinic acid (intravenous)	Drug: Folinic Acid, interferon-alpha 5-FU, 450 mg/m² i.v. for 60 min, weekly for 52 weeks postoperatively Folinic acid, 200 mg/m² i.v. 10 min, weekly for 52 weeks postoperatively 6x10 (high6) I.U. as subcutaneous self injection 3x weekly. Training of self injection was initiated on day 28 (duration until week 52)
Experimental: 5-FU + Interferon-alpha Experimental arm Systemic drug administration of 5-FU + interferon-alpha (intravenous)	Drug: Folinic Acid, interferon-alpha 5-FU, 450 mg/m² i.v. for 60 min, weekly for 52 weeks postoperatively Folinic acid, 200 mg/m² i.v. 10 min, weekly for 52 weeks postoperatively 6x10 (high6) I.U. as subcutaneous self injection 3x weekly. Training of self injection was initiated on day 28 (duration until week 52)

Detailed Description:

Primary endpoint was overall survival (OS). For sample size estimation the following assumptions were made: The 5-year OS rate of 5-FU was estimated to be 58%. Our intention was to detect an increase in the 5-year OS rate by one of the additives of at least 10% with a power of 80% and a level of significance of 5% in comparison to 5-FU (one-sided). Hypotheses were analyzed as pair wise comparisons between the treatment options. This resulted in a target sample size of 280 patients per group and a total of 840 patients.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Eligibility was defined as potentially curative en-bloc resection (R0) of an adenocarcinoma of the rectum with a lower tumor edge within 12 cm from the anal verge determined by rectoscopy, a pathologic UICC stage II (pT3/4pN0M0) or III (pT1-4pNposM0) with examination of at least 12 lymph nodes, a white blood count ≥ 3,500/µl, a platelet count ≥ 100,000/µl, a ECOG performance status of 0 or 1, and written informed consent.

Exclusion Criteria:

Ineligible were patients not fulfilling these criteria or having a history of cancer except for adequately treated superficial basal or squamous cell skin cancer or in situ carcinoma of the cervix, getting previous radio- or chemotherapy, pregnant or nursing women, other having severe concomitant diseases limiting life expectancy or not allowing chemotherapy, and with social conditions not allowing a 5-year follow-up.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01060501

Locations

Germany
Department of General, Visceral, and Transplantation Surgery, University of Ulm
Ulm, Germany, 89075

Sponsors and Collaborators

University of Ulm

Medac GmbH (Hamburg, Germany)

Roche (Grenzach-Wyhlen, Germany)

More Information

Additional Information:

homepage of institution This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Prof. Dr. Marko Kornmann, Study Group Oncology of Gastrointestinal Tumors (FOGT)
ClinicalTrials.gov Identifier:	NCT01060501 History of Changes
Other Study ID Numbers:	FOGT1
Study First Received:	February 1, 2010
Last Updated:	February 1, 2010
Health Authority:	"Federal Institute for Drugs and Medicinal Devices":Germany

Keywords provided by University of Ulm:

rectal cancer
adjuvant chemoradiotherapy
5-FU, interferon-alpha
Locally advanced resectable rectal cancer (UICC stage II and III)
Adjuvant chemoradiotherapy

Additional relevant MeSH terms:

Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Adjuvants, Immunologic
Interferon-alpha
Interferon Alfa-2a
Interferons

Fluorouracil
Leucovorin
Folic Acid
Levoleucovorin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 23, 2013

Modulation of Adjuvant 5-FU by Folinic Acid and Interferon-alpha in Colon Cancer (FOGT1)