NEOadjuvant chemotherapy only compared with standard treatment for Locally Advanced Rectal cancer: a randomized phase II trial

Phase 1/2

Active, not recruiting

• Conditions: Rectum cancer

• Registration Number: 2024-517748-76-00
• Lead Sponsor: Region Sjaelland

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.

Study Timeline

• Study First Posted: 2024-10-08
• Last Update Posted: 2024-10-08

Recruitment & Eligibility

• Status: Ongoing, recruitment ended
• Sex: Not specified
• Target Recruitment: 124

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 0-2. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Disease free survival		Disease free survival

Secondary Outcome Measures

Name	Time	Method
• 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		• 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

Trial Locations

Locations (6)

Region Nordjylland; 🇩🇰 Aalborg, Denmark

Region Syddanmark; 🇩🇰 Odense C, Denmark

Region Midtjylland; 🇩🇰 Aarhus N, Denmark

Region Hovedstaden; 🇩🇰 Herlev, Denmark

Rigshospitalet; 🇩🇰 Copenhagen Oe, Denmark

Region Sjaelland; 🇩🇰 Koege, Denmark

Region Nordjylland

🇩🇰Aalborg, Denmark

Laurids Østergaard Poulsen

Site contact

97666795

laop@rn.dk