2024-517748-76-00
Active, not recruiting
Phase 1/2
NEOadjuvant chemotherapy only compared with standard treatment for Locally Advanced Rectal cancer: a randomized phase II trial
Drugs5-FU medac 50 mg/ml, InjektionslösungCapecitabine Pharmacare 150 mg film-coated tabletsCapecitabine Accord 500 mg film-coated tabletsOxaliplatin 5mg/ml concentrate for Solution for InfusionLeucovorin 10 mg/ml Lösung zur Injektion/ InfusionCapecitabine Glenmark 150 mg film-coated tabletsCapecitabine Pharmacare 150 mg film-coated tablets, Capecitabine Accord 500 mg film-coated tabletsCapecitabine Glenmark 500 mg filmomhulde tablettenCapecitabine Glenmark 150 mg film-coated tablets, Capecitabine Glenmark 500 mg filmomhulde tabletten
Overview
- Phase
- Phase 1/2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Region Sjaelland
- Enrollment
- 124
- Locations
- 6
- Primary Endpoint
- Disease free survival
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
The aim of the present study is to compare long term and short term outcomes in rectal cancer patients undergoing standard treatment (radio-chemotherapy/surgery) or experimental neoadjuvant chemotherapy/surgery
Detailed Description
The standard treatment of locally advanced but resectable cancer in the middle or lower rectum is preoperative radio-chemotherapy and in the upper part initial surgery. The clinical benefit from radio-chemotherapy is primarily through a reduction in local relapse but the treatment is associated with acute toxicity and long term functional dysfunction. Subsequently, it is important to select patients with high risk of local relapse. Intense systemic combination chemotherapy reduces the risk of distant relapse and increases survival in the postoperative setting. The biological rationale is eradication of micrometastases and hence it may be anticipated that earlier, i.e. neoadjuvant, combination therapy may improve systemic control.
Investigators
Ismail Gögenur
Scientific
Region Sjaelland
Eligibility Criteria
Inclusion Criteria
- •Adenocarcinoma of the rectum with the lower boarder within 15 cm from the anal verge. Locally advanced tumor based on imaging (Tumors within 10 cm from the anal verge fulfilling the criteria for preoperative radio-chemotherapy according to DCCG guidelines, T3c or T4 tumors 10-15 cm from the anal verge). Deemed resectable at the multidisciplinary team (MDT) conference. ECOG performance status 0-
- •Age at least 18 years. Adequate bone marrow, liver and renal function allowing systemic chemotherapy (Absolute neutrophil count ≥1.5x109/l and thrombocytes ≥ 100x109/l., Bilirubin ≤ 1.5 x upper normal value and alanine aminotransferase ≤ 3 x upper normal value, Calculated or measured renal glomerular filtration rate at least 30 mL/min). Anticonception for fertile women and for male patients with a fertile partner. Intrauterine device, vasectomy of a female subject’s male partner or hormonal contraceptive are acceptable. Written and orally informed consent
Exclusion Criteria
- •Distant metastasis • Invasive ingrowth into other organs • Incapacity, frailty, disability and comorbidity to a degree that according to the investigator is not compatible with combination chemotherapy • Previous radiotherapy to the pelvis • Previous treatment with 5FU or oxaliplatin • Surgery within two weeks • Neuropathy NCI grade > 1 • Other malignant tumor within 5 years except non-melanoma skin cancer or carcinoma in situ cervicis uteri • Pregnant (positive pregnancy test) or breast feeding women
Outcomes
Primary Outcomes
Disease free survival
Disease free survival
Secondary Outcomes
- • Overall survival • Local and distant relapse • Early and late toxicity • Functional outcome and QoL • Resection rate • Postoperative morbidity • Postoperative mortality • Rate of downsizing • Tumor regression grade • Translational research
Study Sites (6)
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