Study of Neoadjuvant Chemotherapeutic Treatment (XELOX) Followed by Chemoradiotherapy (XELOX/RT) and Surgery Versus Chemoradiotherapy Followed by Surgery and Chemotherapy in Patients With High Risk Rectal Cancer

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2010-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Primary:

* To assess complete pathological response rate of both strategies.

Secondary:

* Safety profile
* To assess downstaging rate of both strategies.
* To compare relative dose intensity of oxaliplatin and capecitabine of both strategies
* To compare time to progression and overall survival of both strategies.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Preoperative Combined Induction Chemotherapy With Capecitabine, Oxaliplatin, Bevacizumab and Radiotherapy

NCT01434147

Rectal Cancer

COMPLETED PHASE2

CORE: Capecitabine, Oxaliplatin, Radiotherapy and Excision

NCT00174616

Rectal Neoplasms

COMPLETED PHASE2

A Phase II Study of Oxaliplatin Capecitabine and Pre-operative Radiotherapy for Patients With Locally Advanced and Inoperable Rectal Cancer

NCT00220051

Rectal Cancer

COMPLETED PHASE2

Study of Neoadjuvant CT With Selective Radiotherapy in Patients With Intermediate-Risk Cancer Rectum

NCT00909987

Rectum Cancer

COMPLETED PHASE2

Induction Chemotherapy for Locally Recurrent Rectal Cancer

NCT04389086

Recurrent Rectal Cancer

RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rectal Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

Group Type EXPERIMENTAL

Oxaliplatin, capecitabine

Intervention Type DRUG

OXA 130 D1 + Capecitabine 2000 / day D1-D14 for 4 cycles. After 10 weeks of rest, XELOX-RT regimen x 5 weeks followed by surgery

B

Group Type EXPERIMENTAL

Oxaliplatin, capecitabine

Intervention Type DRUG

XELOX-RT x 5 weeks followed by surgery and 4 cycles of adjuvant XELOX with the same scheme as arm A.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Oxaliplatin, capecitabine

OXA 130 D1 + Capecitabine 2000 / day D1-D14 for 4 cycles. After 10 weeks of rest, XELOX-RT regimen x 5 weeks followed by surgery

Intervention Type DRUG

Oxaliplatin, capecitabine

XELOX-RT x 5 weeks followed by surgery and 4 cycles of adjuvant XELOX with the same scheme as arm A.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Radiotherapy Radiotherapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with rectal adenocarcinoma.
* Operable tumour, confirmed by magnetic resonance of high resolution and / or endorectal echography, or,
* Rectal tumour at distal third, or
* Tumours spread more than 5 mm in perirectal fat
* Functional state ECOG ≤ 2.
* Good hematological, hepatic and renal function

Exclusion Criteria

* Previous pelvis radiotherapy.
* Previous antitumoural chemotherapy
* Pregnant or breastfeeding women.
* Childbearing women with a positive pregnancy test result at baseline. Menopausal women should not have the period for the last 12 months.
* History of any other neoplastic illness within the last 5 years, except for already resolved small cell skin cancer or cervix cancer.
* Clinically significant cardiovascular disease
* Confirmed peripheral neuropathy.
* Gastrointestinal disorders or bad absorption syndrome or non-capable to take oral medication.
* Blood disorders.
* Intercurrent non-controlled or severe infections.
* Patients who have undergone major surgery, open biopsies or with significant trauma lesions within the previous 28 days.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No