Curative Chemoradiation of Low Rectal Cancer

N/AActive Not RecruitingNCT02438839

Vejle Hospital108 enrolled

Overview

The aim of the present study is to investigate whether curative chemoradiation of low rectal cancer is feasible, safe and effective in a multicenter study with results comparable to those of single center studies. Results from previous studies indicate that a considerable fraction of patients with low rectal cancer can be cured by a combination of radiation and chemotherapy alone and thus be spared from operation.

Study Type

OBSERVATIONAL

Enrollment

108

Conditions

Rectal Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histopathologically verified adenocarcinoma of the rectum * Planned abdominoperineal resection (APR) or ultralow resection * Primary, resectable T1-T3, N0 tumor. N1 nodal disease is acceptable, if the positive lymph nodes are localized to the mesorectum at the level of the tumor. * Distance from anal verge to lower edge of tumor ≤ 6 cm measured by rigid rectoscope * Performance status 0-2 * Patient acceptance to collection of biopsies and blood samples for translational research * Age ≥ 18 years * Normal function of bone marrow as evaluated by * neutrophils ≥ 1.5 x 10\^9/l * thrombocytes ≥ 100 * Normal function of liver * alanine aminotransferase (ALAT) \< 2.5 x upper limit of normal * bilirubin \< 2.5 x upper limit of normal * Kidney function \- Serum creatinine \< 1.5 x upper limit of normal or measured glomerular filtration rate (GFR) \> 30 ml/min * Fertile women must present a negative pregnancy test and use secure contraceptives during and 3 months after treatment. * Written and orally informed consent Exclusion Criteria: * Previous surgical treatment of the present cancer, including transanal excision of tumor. * Other malignant disease within the past five years except basocellular skin cancer and carcinoma in situ cervicis uteri * Distant metastases verified by imaging or biopsy * Previous radiation treatment of the pelvis * Pregnant or breastfeeding women

Locations (5)

Department of Oncology, Aalborg University Hospital

Aalborg, Denmark

Department of Surgery, Aalborg University Hospital

Aalborg, Denmark

Department of Oncology, Rigshospitalet

Copenhagen, Denmark

Department of Oncology, Vejle Hospital

Vejle, Denmark

Outcomes

Primary Outcomes

Proportion of patients with locoregional tumor control with chemoradiation alone two years after end of treatment

Time frame: 2 years after end of treatment

Secondary Outcomes

Cumulative incidence of local recurrence after surgery

Time frame: Every two months the first year, every three months the second year, every six months the third year, and annually the fourth and fifth years

Rate of distant metastases

Time frame: Every two months the first year, every three months the second year, every six months the third year, and annually the fourth and fifth years

Response and tumor control on MRI scans compared to clinical observations, including rectoscopic examination

Time frame: 6 and potentially 12 weeks after end of treatment

Data from ClinicalTrials.gov

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