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Phase 3 Study of Adjuvant Chemoradiotherapy of Advanced Resectable Rectal Cancer Comparing Modulation of 5-FU With Folinic Acid or With Interferon-alpha


Phase 3
18 Years
N/A
Not Enrolling
Both
Rectal Cancer

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Trial Information

Phase 3 Study of Adjuvant Chemoradiotherapy of Advanced Resectable Rectal Cancer Comparing Modulation of 5-FU With Folinic Acid or With Interferon-alpha


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Time Frame:

5-year

Safety Issue:

No

Authority:

"Federal Institute for Drugs and Medicinal Devices":Germany

Study ID:

FOGT1

NCT ID:

NCT01060501

Start Date:

July 1992

Completion Date:

July 2009

Related Keywords:

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

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