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

NCT ID: NCT03280407

Last Updated: 2017-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A, capecitabine

Radiochemotherapy with 50.4 Gy in 28 fractions concomitantly with chemotherapy

Group Type ACTIVE_COMPARATOR

Capecitabine

Intervention Type 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

B, FOLFOX or CAPOX

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

Group Type EXPERIMENTAL

FOLFOX regimen (oxaliplatin/leucovorin/5FU)

Intervention Type 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.

CAPOX (oxaliplatin/capecitabine)

Intervention Type DRUG

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

Interventions

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Capecitabine

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

Intervention Type DRUG

FOLFOX regimen (oxaliplatin/leucovorin/5FU)

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.

Intervention Type DRUG

CAPOX (oxaliplatin/capecitabine)

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

Intervention Type DRUG

Other Intervention Names

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FOLFOX (oxaliplatin/leucovorin/5FU)

Eligibility Criteria

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Inclusion Criteria

* 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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zealand University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ismail Gögenur

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ismail Gögenur, MD

Role: STUDY_CHAIR

Department of Surgery, ZUH

Lars Henrik Jensen, MD

Role: PRINCIPAL_INVESTIGATOR

Vejle Hospital

Locations

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Vejle Hospital

Vejle, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Ismail Gögenur, MD

Role: CONTACT

[email protected]
+45 26336426

Lars Henrik Jensen, MD

Role: CONTACT

Facility Contacts

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Lars Henrik Jensen, MD PhD

Role: primary

[email protected]

Other Identifiers

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S-20160158

Identifier Type: -

Identifier Source: org_study_id