NEOadjuvant Chemotherapy Only Compared With Standard Treatment for Locally Advanced Rectal Cancer

NCT03280407 | Unknown Phase 2 DMC

• 1 other identifier: S-20160158
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

The main clinical hypothesis is that compared to radio-chemotherapy for low and mid rectal tumors or surgery for high rectal tumors neoadjuvant chemotherapy reduces the rate of distant relapse without increasing the rate of local relapse. 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 Furthermore, early surgical and medical complications, the functional outcome, toxicity and quality of life (QoL) may be improved if radiotherapy can be avoided. Exploratory analyses are planned in order to find potential predictive markers for selecting patients to either radio-chemotherapy/surgery or neoadjuvant combination chemotherapy/surgery.

Conditions

Colorectal Neoplasm; Colorectal Cancer; Rectal Neoplasms; Chemotherapy Effect; Intestinal Disease; Intestinal Neoplasms; Rectal Cancer

Keywords

Neoadjuvant chemotherapy,; locally advanced rectal cancer,; chemotherapy; CAPOX (oxaliplatin/capecitabine); FOLFOX (oxaliplatin/leucovorin/5FU)

Outcome Measures

Primary Outcomes (1)

• Disease free survival

  All patients will be evaluated with CT and MRI scans and clinically every 6 months for 2 years and annually until the number of events is reached and the trial is stopped (max 5 years)

  5 years

Secondary Outcomes (7)

• Overall survival

  5 years

• Local relapse

  5 years

• Distant relapse

  5 years

• Early toxicity

  5 years

• Late toxicity

  5 years

Study Arms (2)

A, capecitabine

ACTIVE COMPARATOR

Radiochemotherapy with 50.4 Gy in 28 fractions concomitantly with chemotherapy

Drug: Capecitabine

B, FOLFOX or CAPOX

EXPERIMENTAL

Neoadjuvant chemotherapy with CAPOX (oxaliplatin/capecitabine) or FOLFOX regimen (oxaliplatin/leucovorin/5FU), according to institutional practice

Drug: FOLFOX regimen (oxaliplatin/leucovorin/5FU); Drug: CAPOX (oxaliplatin/capecitabine)

Interventions

Capecitabine DRUG

Radio-chemotherapy with 50.4 Gy in 28 fractions to tumor and regional lymph nodes concomitantly with capecitabine 825 mg/m2 b.i.d

A, capecitabine

FOLFOX regimen (oxaliplatin/leucovorin/5FU) DRUG

Six cycles: Oxaliplatin 85 mg/m2 day 1, leucovorin 400 mg/m2 day 1, 5FU 400 mg/m2 bolus day 1 and 5FU 2400 mg/ m2 over 46-48 hours day 1-3, repeated every two weeks.

Also known as: FOLFOX (oxaliplatin/leucovorin/5FU)

B, FOLFOX or CAPOX

CAPOX (oxaliplatin/capecitabine) DRUG

Four cycles: Oxaliplatin 130 mg/m2 day 1 and capecitabine 1000 mg/m2 b.i.d. days 1-14, repeated every 3 weeks.

B, FOLFOX or CAPOX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adenocarcinoma of the rectum with the lower boarder within 15 cm from the anal verge
• Locally advanced tumor based on imaging
• T3 tumors within 10 cm from the anal verge fulfilling the criteria for preoperative radio-chemotherapy according to Danish Colorectal Cancer Group (DCCG) guidelines
• T3c or T4 tumors 10-15 cm from the anal verge
• Deemed resectable at the multidisciplinary team (MDT) conference
• Eastern Cooperative Oncology Group (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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Vejle Hospital

Vejle, Denmark

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Rectal Neoplasms; Intestinal Diseases; Intestinal Neoplasms

Interventions

Capecitabine; Folfox protocol; Oxaliplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Study Officials

• Ismail Gögenur, MD

  Department of Surgery, ZUH

  STUDY CHAIR

• Lars Henrik Jensen, MD

  Vejle Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ismail Gögenur, MD

CONTACT

+45 26336426; igo@regionsjaelland.dk

Lars Henrik Jensen, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is an open label, randomized phase II screening trial allocating eligible patients to either standard treatment for rectal cancer or experimental preoperative combination chemotherapy.

Study Record Dates

• First Submitted: September 7, 2017
• First Posted: September 12, 2017
• Study Start: March 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2024
• Last Updated: September 28, 2017

Record last verified: 2017-09

Locations

DK (1)