Rectal Cancers. Clinical Trial
Official title:
A Phase II Trial of Preoperative Concurrent Chemotherapy and (IMRT) in Locally Advanced Rectal Cancer
The hypothesis of this study is that dose escalated intensity modulated radiotherapy (IMRT) to a dose of 55Gy in 25# to primary rectal tumor concurrent with oral capecitabine results in an improved pathological response rate from 8% (German trial) to 25%.
| Status | Recruiting |
| Enrollment | 63 |
| Est. completion date | January 2013 |
| Est. primary completion date | January 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 21 Years to 90 Years |
| Eligibility |
Inclusion Criteria: - Pathologically proven diagnosis of adenocarcinoma of the rectum - Clinically determined to be stage T3 or T4,N0-N2, and M0 -staged by MRI or transrectal ultrasound of the rectum - Patients who are medically operable and who have resectable adenocarcinoma of the rectum at least <15cm from the anal verge - Adequate liver/renal and haematological function. - Eastern Cooperative Oncology Group (ECOG) performance 0-2 - Age = 18 years - Full blood count obtained within 2 weeks prior to registration on study, with adequate bone marrow function defined as follows: - Absolute neutrophil count (ANC) = 1,800 cells/mm3 - Platelets = 100,000 cells/mm3 - Haemoglobin = 8.0 g/dl - Serum creatinine within normal institutional limits or creatinine clearance = 50 ml/min - Bilirubin within normal institutional limits - AST and ALT < 2.5 x the IULN - Patient must sign study specific informed consent prior to study entry Exclusion Criteria: Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years - Prior systemic chemotherapy for colorectal cancer; note that prior chemotherapy for a different cancer is allowable. - Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields - Severe, active comorbidity, defined as follows: - Unstable angina and/or congestive heart failure requiring hospitalization within the last 12 months - Transmural myocardial infarction within the last 6 months - Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects - Acquired immune deficiency syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. - Evidence of uncontrolled seizures, central nervous system disorders, or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake. - Known, existing uncontrolled coagulopathy. Patients on therapeutic anticoagulation may be enrolled provided that they have been clinically stable on anti-coagulation for at least 2 weeks. - Major surgery within 28 days of study enrollment (other than diverting colostomy) - Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic - Prior allergic reaction to capecitabine - Any evidence of distant metastases (M1) - A synchronous primary colon carcinoma - Extension of malignant disease into the anal canal - Lack of physical integrity of the gastrointestinal tract (i.e., severe Crohn's disease that results in - malabsorption; significant bowel resection that would make one concerned about the absorption of capecitabine) or malabsorption syndrome that would preclude feasibility of oral chemotherapy (capecitabine) - Participation in any investigational drug study within 28 days of study enrollment |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Singapore | National University Hospital | Singapore |
| Lead Sponsor | Collaborator |
|---|---|
| National University Hospital, Singapore | Tan Tock Seng Hospital |
Singapore,
Ryan R, Gibbons D, Hyland JM, Treanor D, White A, Mulcahy HE, O'Donoghue DP, Moriarty M, Fennelly D, Sheahan K. Pathological response following long-course neoadjuvant chemoradiotherapy for locally advanced rectal cancer. Histopathology. 2005 Aug;47(2):141-6. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pathological complete response rates | Pathogical complete response rate 8 weeks post chemoradiotherapy at surgery according to Ryan's classification | 8 weeks post chemoradiotherapy | No |
| Secondary | Toxicity | Toxicity including anorexia, nausea, vomiting, diarrhoea, dermatitis, proctitis, urinary frequency/urgency as per common toxicity criteria v3.0 | 2 years | Yes |
| Secondary | Disease Free survival | Time from study entry to disease recurrence or death | 2 years | No |
| Secondary | Downstaging rates | percentage of patients who achieve downstaging 8 weeks post chemoradiotherapy at surgery according to TNM classification | 8 weeks after chemoradiotherapy | No |
| Secondary | Sphincter Preservation rates | Sphincter Preservation rates 8 weeks post chemoradiotherapy at surgery.Percentage of patients who underwent sphincter salvage surgery after chemoradiotherapy | 8 weeks after chemoradiotherapy | No |