Suspended

Neoadjuvant Celecoxib and Capecitabine Combined With Pelvic Irradiation in Treating Patients With Stage II or Stage III Adenocarcinoma (Cancer) of the Rectum

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What is being tested

capecitabine

+ celecoxib
+ radiation therapy
Drug
Radiation
Procedure
Who is being recruted

Colorectal Cancer

Over 18 Years
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: December 2004

Summary

Principal SponsorAlliance for Clinical Trials in Oncology
Last updated: December 15, 2016
Sourced from a government-validated database.Claim as a partner
Study start date: December 1, 2004Actual date on which the first participant was enrolled.

RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Celecoxib may also make tumor cells more sensitive to chemotherapy and radiation therapy. Giving celecoxib with capecitabine and radiation therapy before surgery may shrink the tumor so that it can be removed. PURPOSE: This phase II trial is studying how well giving neoadjuvant celecoxib together with capecitabine and pelvic irradiation works in treating patients with stage II or stage III adenocarcinoma (cancer) of the rectum. OBJECTIVES: Primary * Determine the pathological complete response rate in patients with stage II or III adenocarcinoma of the rectum treated with neoadjuvant celecoxib and capecitabine in combination with pelvic irradiation. Secondary * Determine the safety and tolerability of this regimen in these patients. * Determine the rectal function of patients treated with this regimen. * Determine the time to recurrence or progression and survival time of patients treated with this regimen. * Correlate cellular and molecular markers in pretreatment tumor samples with response in patients treated with this regimen. OUTLINE: This is a multicenter study. * Neoadjuvant chemoradiotherapy: Patients receive oral celecoxib twice daily on days 1-7 and oral capecitabine twice daily on days 1-5. Patients undergo pelvic radiotherapy once daily on days 1-5. Courses repeat weekly for 5.5 weeks. * Surgery: Patients undergo surgery 4-6 weeks after completion of neoadjuvant chemoradiotherapy. * Adjuvant chemotherapy: Patients with a curative resection receive oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for up to 4 courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 4 years.

Official TitleA Phase II Trial Of Celecoxib (Celebrex) And Capecitabine (Xeloda) Combined With Pelvic Irradiation As Neoadjuvant Treatment Of Stage II or III Adenocarcinoma Of The Rectum 
Principal SponsorAlliance for Clinical Trials in Oncology
Last updated: December 15, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
3 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Colorectal Cancer
Criteria

DISEASE CHARACTERISTICS: * Histologically confirmed rectal adenocarcinoma * Clinical stage T3, N0, M0 OR any T, N1-3, M0 disease * Treatment with neoadjuvant chemotherapy and pelvic radiotherapy is indicated * All disease must be encompassable within standard pelvic radiotherapy fields * Distal border of the tumor must be at or below\* the peritoneal reflection, defined as within 12 cm of the anal verge by endoscopy NOTE: \*If a portion of the tumor is below the peritoneal reflection at the time of surgery, patients are eligible regardless of the distance of the tumor determined at endoscopy * Tumor must be determined to be clinically resectable * Tumor may not be clinically fixed * Negative margins by routine examination of an unanesthetized patient * Transmural penetration of tumor through the muscularis propria by CT scan, endorectal ultrasound, or MRI * No distant metastatic disease * No evidence of tumor outside the pelvis, including any of the following: * Metastatic inguinal lymphadenopathy * Peritoneal seeding * Liver metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * At least 6 months Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ upper limit of normal (ULN) * AST ≤ 3 times ULN * Alkaline phosphatase ≤ 4 times ULN if AST \< ULN Renal * Creatinine clearance ≥ 30 mL/min * No renal impairment Cardiovascular * No congestive heart failure * No symptomatic coronary artery disease * No uncontrolled cardiac arrhythmias * No myocardial infarction * No history of transient ischemic attacks or stroke * No other clinically significant cardiac disease Gastrointestinal * No bleeding peptic ulcer disease within the past 12 months * No lack of physical integrity of the upper gastrointestinal tract * No malabsorption syndrome * No active inflammatory bowel disease * Must be able to swallow study drugs Other * No dihydropyrimidine dehydrogenase deficiency * No history of uncontrolled seizures * No CNS disorders * No clinically significant psychiatric illness that would preclude study compliance or giving informed consent * No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * No known sensitivity to NSAIDs, sulfonamides, or aspirin * No other serious medical illness that would preclude study treatment * No other conditions that would preclude study participation * Must be able to tolerate major surgery that may include abdominal-perineal resection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 30 days after study treatment PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics * No prior systemic anticancer chemotherapy Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * No prior radiotherapy to the pelvis Surgery * See Disease Characteristics * More than 3 weeks since prior major surgery and recovered Other * At least 7 days since prior nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin * No other concurrent investigational drugs * No other concurrent anticancer treatment * No concurrent NSAIDs * No concurrent primary prophylactic therapy for hand-foot syndrome * No concurrent loperamide prophylaxis for diarrhea * No concurrent sorivudine or brivudine


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Neoadjuvant chemoradiotherapy: Patients receive oral celecoxib twice daily on days 1-7 and oral capecitabine twice daily on days 1-5. Patients undergo pelvic radiotherapy once daily on days 1-5. Courses repeat weekly for 5.5 weeks. Surgery: Patients undergo surgery 4-6 weeks after completion of neoadjuvant chemoradiotherapy. Adjuvant chemotherapy: Patients with a curative resection receive oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for up to 4 courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 4 years.
Study Objectives
Primary Objectives

Secondary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available. 

SuspendedNo study centers