Preoperative Concurrent Chemotherapy and Intensity Modulated Radiotherapy (IMRT) in Locally Advanced Rectal Cancer

NCT01340508 | Unknown Phase 2 DMC

• 1 other identifier: B/09/377
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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%.

Conditions

Rectal Cancers.

Keywords

Pathological complete response; Intensity modulated radiotherapy; Rectal cancer

Outcome Measures

Primary Outcomes (1)

• Pathological complete response rates

  Pathogical complete response rate 8 weeks post chemoradiotherapy at surgery according to Ryan's classification

  8 weeks post chemoradiotherapy

Secondary Outcomes (4)

• Toxicity

  2 years

• Disease Free survival

  2 years

• Downstaging rates

  8 weeks after chemoradiotherapy

• Sphincter Preservation rates

  8 weeks after chemoradiotherapy

Study Arms (1)

Intensity modulated Radiotherapy

EXPERIMENTAL

Intensity modulated radiotherapy, dose escalation, rectal cancer, volumetric modulated arc therapy

Radiation: Intensity Modulated Radiotherapy

Interventions

Intensity Modulated Radiotherapy RADIATION

Intensity modulated radiotherapy to a dose of 55Gy in 25 fractions

Also known as: Intensity modulated radiotherapy. Dose escalation.

Intensity modulated Radiotherapy

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Prior allergic reaction to capecitabine
• Any evidence of distant metastases (M1)
• A synchronous primary colon carcinoma
• Extension of malignant disease into the anal canal

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• Tan Tock Seng Hospital: collaborator

Study Sites (1)

National University Hospital

Singapore, Singapore, 119074, Singapore

RECRUITING

Related Publications (1)

• 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. doi: 10.1111/j.1365-2559.2005.02176.x.

  PMID: 16045774 BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Jeremy Tey, FRANZCR

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 18, 2011
• First Posted: April 22, 2011
• Study Start: January 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: April 22, 2011

Record last verified: 2011-04

Locations

SG (1)