Trial Outcomes & Findings for Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer (NCT NCT00093379)
NCT ID: NCT00093379
Last Updated: 2023-04-18
Results Overview
Treatment failure defined as: Biopsy proven residual disease identified 12 -14 weeks after the conclusion of chemoradiation therapy, Treatment-related mortality or Disease recurrence.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
2 years
Results posted on
2023-04-18
Participant Flow
The recruitment period: April 16, 2004 to May 12, 2009. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.
Participant milestones
| Measure |
Capecitabine + Oxaliplatin + XRT
Capecitabine (825 mg/m\^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m\^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy (XRT) once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer
Baseline characteristics by cohort
| Measure |
Capecitabine + Oxaliplatin + XRT
n=20 Participants
Capecitabine (825 mg/m\^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m\^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.
|
|---|---|
|
Age, Continuous
|
55 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsTreatment failure defined as: Biopsy proven residual disease identified 12 -14 weeks after the conclusion of chemoradiation therapy, Treatment-related mortality or Disease recurrence.
Outcome measures
| Measure |
Capecitabine + Oxaliplatin + XRT
n=20 Participants
Capecitabine (825 mg/m\^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m\^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.
|
|---|---|
|
2 Year Failure Free Survival
|
20 participants
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: Three (3) participants were not evaluable for response.
Response determined by computed tomography (CT)/magnetic resonance imaging (MRI), digital rectal examination, and proctoscopy, and a biopsy performed for clinical suspicion of residual or progressive disease. Response Evaluation Criteria in Solid Tumors (RECIST) where evaluation of target lesions Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Outcome measures
| Measure |
Capecitabine + Oxaliplatin + XRT
n=17 Participants
Capecitabine (825 mg/m\^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m\^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.
|
|---|---|
|
Number of Participants With Complete Response at 2 Years
|
16 participants
|
SECONDARY outcome
Timeframe: 2 Years with median study follow up of 19 monthsColostomy-free survival reported as number of participants who did not develop local recurrence or require salvage resection with colostomy.
Outcome measures
| Measure |
Capecitabine + Oxaliplatin + XRT
n=20 Participants
Capecitabine (825 mg/m\^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m\^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.
|
|---|---|
|
Number of Participants With 2-year Colostomy-Free Survival
|
20 participants
|
SECONDARY outcome
Timeframe: 2 YearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 YearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 YearsOutcome measures
Outcome data not reported
Adverse Events
Capecitabine + Oxaliplatin + XRT
Serious events: 20 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Capecitabine + Oxaliplatin + XRT
n=20 participants at risk
Capecitabine (825 mg/m\^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m\^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.
|
|---|---|
|
Blood and lymphatic system disorders
•Increased Aspartate aminotransferase (AST, SGOT)
|
5.0%
1/20 • 5 years and 9 months
|
|
General disorders
Dehydration
|
5.0%
1/20 • 5 years and 9 months
|
|
Infections and infestations
Allergic Reaction Including Drug Fever
|
5.0%
1/20 • 5 years and 9 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis (Chemoradiation)
|
5.0%
1/20 • 5 years and 9 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis (Radiation)
|
20.0%
4/20 • 5 years and 9 months
|
|
Gastrointestinal disorders
Diarrhea
|
30.0%
6/20 • 5 years and 9 months
|
|
General disorders
Fatigue
|
5.0%
1/20 • 5 years and 9 months
|
|
Blood and lymphatic system disorders
Hemoglobin
|
5.0%
1/20 • 5 years and 9 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.0%
1/20 • 5 years and 9 months
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • 5 years and 9 months
|
|
General disorders
Pain
|
20.0%
4/20 • 5 years and 9 months
|
Other adverse events
| Measure |
Capecitabine + Oxaliplatin + XRT
n=20 participants at risk
Capecitabine (825 mg/m\^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m\^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.
|
|---|---|
|
Metabolism and nutrition disorders
Allergic Reaction Including Drug Fever
|
5.0%
1/20 • 5 years and 9 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.0%
1/20 • 5 years and 9 months
|
|
Blood and lymphatic system disorders
Increased Alanine aminotransferase (ALT, SGPT)
|
15.0%
3/20 • 5 years and 9 months
|
|
Metabolism and nutrition disorders
Anorexia
|
30.0%
6/20 • 5 years and 9 months
|
|
Blood and lymphatic system disorders
Increased Aspartate aminotransferase (AST, SGOT)
|
15.0%
3/20 • 5 years and 9 months
|
|
Blood and lymphatic system disorders
Elevated Bilirubin
|
5.0%
1/20 • 5 years and 9 months
|
|
Gastrointestinal disorders
Bloody Stool
|
5.0%
1/20 • 5 years and 9 months
|
|
Eye disorders
Blurred Vision
|
5.0%
1/20 • 5 years and 9 months
|
|
Gastrointestinal disorders
Bowel Movement, Changes
|
5.0%
1/20 • 5 years and 9 months
|
|
Renal and urinary disorders
Blood urea nitrogen (BUN) Increase
|
5.0%
1/20 • 5 years and 9 months
|
|
Injury, poisoning and procedural complications
Burn
|
5.0%
1/20 • 5 years and 9 months
|
|
Nervous system disorders
Cold Intolerance
|
10.0%
2/20 • 5 years and 9 months
|
|
Gastrointestinal disorders
Constipation
|
25.0%
5/20 • 5 years and 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • 5 years and 9 months
|
|
Reproductive system and breast disorders
Cystitis
|
5.0%
1/20 • 5 years and 9 months
|
|
Metabolism and nutrition disorders
Dehydration
|
15.0%
3/20 • 5 years and 9 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis (Chemoradiation)
|
40.0%
8/20 • 5 years and 9 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis (Radiation)
|
20.0%
4/20 • 5 years and 9 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin (Other)
|
5.0%
1/20 • 5 years and 9 months
|
|
Gastrointestinal disorders
Diarrhea
|
55.0%
11/20 • 5 years and 9 months
|
|
Nervous system disorders
Dizziness
|
15.0%
3/20 • 5 years and 9 months
|
|
Gastrointestinal disorders
Dry Mouth
|
5.0%
1/20 • 5 years and 9 months
|
|
Renal and urinary disorders
Dysuria
|
5.0%
1/20 • 5 years and 9 months
|
|
General disorders
Fatigue
|
45.0%
9/20 • 5 years and 9 months
|
|
Infections and infestations
Fever Without Neutropenia
|
25.0%
5/20 • 5 years and 9 months
|
|
Gastrointestinal disorders
Flatulence
|
5.0%
1/20 • 5 years and 9 months
|
|
Gastrointestinal disorders
Gastritis
|
5.0%
1/20 • 5 years and 9 months
|
|
Gastrointestinal disorders
Gastrointestinal (Other)
|
15.0%
3/20 • 5 years and 9 months
|
|
Skin and subcutaneous tissue disorders
Hand-Foot Syndrome
|
5.0%
1/20 • 5 years and 9 months
|
|
Blood and lymphatic system disorders
Elevated Hemoglobin
|
15.0%
3/20 • 5 years and 9 months
|
|
Gastrointestinal disorders
GI Hemorrhage
|
20.0%
4/20 • 5 years and 9 months
|
|
Reproductive system and breast disorders
Hot Flashes
|
5.0%
1/20 • 5 years and 9 months
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
10.0%
2/20 • 5 years and 9 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
10.0%
2/20 • 5 years and 9 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.0%
1/20 • 5 years and 9 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
15.0%
3/20 • 5 years and 9 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
10.0%
2/20 • 5 years and 9 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.0%
2/20 • 5 years and 9 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.0%
1/20 • 5 years and 9 months
|
|
Blood and lymphatic system disorders
Hypotension
|
5.0%
1/20 • 5 years and 9 months
|
|
Gastrointestinal disorders
Ileus
|
5.0%
1/20 • 5 years and 9 months
|
|
Infections and infestations
Infection (Other)
|
10.0%
2/20 • 5 years and 9 months
|
|
Infections and infestations
Infection Clinical with Grade 3-4 ANC
|
10.0%
2/20 • 5 years and 9 months
|
|
Infections and infestations
Infection with Normal ANC
|
15.0%
3/20 • 5 years and 9 months
|
|
Psychiatric disorders
Insomnia
|
5.0%
1/20 • 5 years and 9 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.0%
1/20 • 5 years and 9 months
|
|
Metabolism and nutrition disorders
Metabolic Problem
|
5.0%
1/20 • 5 years and 9 months
|
|
Gastrointestinal disorders
Mucositis
|
15.0%
3/20 • 5 years and 9 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramps
|
5.0%
1/20 • 5 years and 9 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Issue (Other)
|
5.0%
1/20 • 5 years and 9 months
|
|
Gastrointestinal disorders
Nausea
|
75.0%
15/20 • 5 years and 9 months
|
|
Nervous system disorders
Neurological Issues (Other)
|
15.0%
3/20 • 5 years and 9 months
|
|
Nervous system disorders
Neuropathy: Cranial
|
5.0%
1/20 • 5 years and 9 months
|
|
Blood and lymphatic system disorders
Increased Neutrophils (Absolute neutrophil count (ANC)/Absolute Granulocyte Count (AGC)
|
5.0%
1/20 • 5 years and 9 months
|
|
General disorders
Pain
|
100.0%
20/20 • 5 years and 9 months
|
|
Gastrointestinal disorders
Proctitis
|
5.0%
1/20 • 5 years and 9 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
1/20 • 5 years and 9 months
|
|
Skin and subcutaneous tissue disorders
Rash Dermatitis (Radiation)
|
5.0%
1/20 • 5 years and 9 months
|
|
Skin and subcutaneous tissue disorders
Rash/Desquamation
|
5.0%
1/20 • 5 years and 9 months
|
|
Gastrointestinal disorders
Rectal Bleeding
|
10.0%
2/20 • 5 years and 9 months
|
|
Renal and urinary disorders
Renal/Genitourinary (Other)
|
25.0%
5/20 • 5 years and 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
5.0%
1/20 • 5 years and 9 months
|
|
General disorders
Rigors/Chills
|
5.0%
1/20 • 5 years and 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Tachycardia
|
5.0%
1/20 • 5 years and 9 months
|
|
Gastrointestinal disorders
Sore Throat
|
5.0%
1/20 • 5 years and 9 months
|
|
Gastrointestinal disorders
Stricture/Stenosis, GI (Rectum)
|
5.0%
1/20 • 5 years and 9 months
|
|
Skin and subcutaneous tissue disorders
Sweating
|
5.0%
1/20 • 5 years and 9 months
|
|
Gastrointestinal disorders
Taste Alteration
|
10.0%
2/20 • 5 years and 9 months
|
|
Blood and lymphatic system disorders
Telangiectasia
|
5.0%
1/20 • 5 years and 9 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.0%
2/20 • 5 years and 9 months
|
|
Gastrointestinal disorders
Ulcer, GI (Rectum)
|
5.0%
1/20 • 5 years and 9 months
|
|
Reproductive system and breast disorders
Vaginal Bleeding
|
5.0%
1/20 • 5 years and 9 months
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
5.0%
1/20 • 5 years and 9 months
|
|
Reproductive system and breast disorders
Vaginal Dryness
|
10.0%
2/20 • 5 years and 9 months
|
|
Reproductive system and breast disorders
Vaginal Stenosis
|
5.0%
1/20 • 5 years and 9 months
|
|
Reproductive system and breast disorders
Vaginitis
|
10.0%
2/20 • 5 years and 9 months
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
5/20 • 5 years and 9 months
|
|
Eye disorders
Watery Eye
|
5.0%
1/20 • 5 years and 9 months
|
|
Gastrointestinal disorders
Weight Loss
|
30.0%
6/20 • 5 years and 9 months
|
|
Reproductive system and breast disorders
Yeast Infection
|
5.0%
1/20 • 5 years and 9 months
|
Additional Information
Cathy Eng, MD/ Professor
The University of Texas (UT) MD Anderson Cancer Center
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place