NCT02919878

Brief Summary

Phase II Study of Neo-adjuvant Chemoradiotherapy using infusional Gemcitabine followed by Surgery for Locally Advanced (T3 and T4 or Node positive) Rectal Adenocarcinoma.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2014

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2015

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

September 29, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 13, 2018

Status Verified

August 1, 2018

Enrollment Period

5 years

First QC Date

March 24, 2015

Last Update Submit

August 9, 2018

Conditions

Rectal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Estimate the rate of pathological complete response following neoadjuvant combined-modality therapy using weekly Gemcitabine and radiation therapy in rectal cancer.

    PCR will be assessed during the course of study

    "3 years"

Secondary Outcomes (3)

  • Estimate the incidence of hematologic and non-hematologic grade 3-4 toxicity with the above regimen

    "3 years"

  • Predictive value of positron Emission Tomography (PET) scan

    within 2 month of finishing pre-operative chemoradiotherapy

  • R0 resection rate

    at the time of surgery ( 2.5 months) from completion of pre-operative chemoradiotherapy

Study Arms (1)

pre-op Gemcitabine & XRT

EXPERIMENTAL

Pre-op chemo: Gemcitabine will be administered as continuous infusion IV over 24 hrs (100 mg/m2) weekly for 6 wks starting on day 1 of Radiotherapy (XRT). XRT/ Intensity modulated radiotherapy(IMRT): 1.8 Gy/fx, 5 fractions/wk will be delivered. Pelvis will receive 45 Gy/25 fractions/5 wks with a boost dose of 5.4 Gy for T3 and 9 Gy for T4 to a cone down volume. The total tumor dose= 50.4 -54 Gy. Post-op chemo: Standard 6 cycles of adjuvant Capecitabine (1250 mg/m2) PO twice per day on days 1-14 each cycle, (every 21 days) in patients who have a complete resection of rectal cancer and negative surgical margins.

Drug: GemcitabineRadiation: XRTDrug: capecitabine

Interventions

GemcitabineDRUG

Nucleoside analog- Chemotherapy

Also known as: Gemzar
pre-op Gemcitabine & XRT
XRTRADIATION

pre-operative radiotherapy given concurrently with Gemcitabine chemotherapy

Also known as: External beam radiotherapy (XRT)
pre-op Gemcitabine & XRT
capecitabineDRUG

Capecitabine is given post operatively as adjuvant chemotherapy for 6 cycles. Each cycle consist of 2500 mg/m2 per day given orally from D1-14

Also known as: Xeloda
pre-op Gemcitabine & XRT

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adenocarcinoma of the rectum without evidence of distant metastases
  • Patient must be 18 years of age or greater
  • Potentially resectable disease based upon surgeons evaluation
  • Clinical stages T3 or T4a, and/ or positive nodes based upon endorectal ultrasound and/ or MRI.
  • Absolute neutrophil count of \> 1500 per microliter and platelet count \> 100,000 per microliter; Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and alkaline phosphatase \< 2.5 X upper limit of normal (ULN), bilirubin \< = 1.5 ULN, calculated creatinine clearance \> 50 ml/min using Cockcroft-Gault formula:
  • Male: Creatinine Clearance = (140 - age) x weight/(72 X serum creatinine) Female: Creatinine Clearance = (140 - age) x weight/(72 X serum creatinine x 0.85)
  • Eastern cooperative oncology group (ECOG) performance status 0-2
  • No history of other malignancies within 5 years, except non-melanoma skin cancer, in situ carcinoma of the cervix, or ductal carcinoma in situ of the breast. Previous invasive cancer permitted if disease free at least 5 years.
  • Signed study-specific informed consent prior to enrolment

You may not qualify if:

  • Any evidence of distant metastasis
  • Synchronous primary colon carcinomas, except T1 lesions (full colonoscopy not required for enrollment)
  • Extension of malignant disease to the anal canal
  • Prior radiation therapy to the pelvis
  • Prior chemotherapy for malignancies
  • Serious, uncontrolled, concurrent infection(s).
  • Participation in any investigational drug study within 4 weeks preceding the start of study treatment
  • Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months.
  • 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
  • Other serious uncontrolled medical conditions that the investigator feels might compromise study participation.
  • Major surgery within 4 weeks of the study treatment
  • Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
  • Known, existing uncontrolled coagulopathy
  • No concurrent cimetidine allowed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oncology Centre, King Faisal Specialist Hospital and Research Centre

Riyadh, 11211, Saudi Arabia

RECRUITING

Related Publications (1)

  • Bazarbashi S, Elshenawy MA, Badran A, Aljubran A, Alzahrani A, Almanea H, Alsuhaibani A, Alashwah A, Neimatallah M, Abduljabbar A, Ashari L, Alhomoud S, Ghebeh H, Elhassan T, Alsanea N, Mohiuddin M. Neoadjuvant concurrent chemoradiotherapy using infusional gemcitabine in locally advanced rectal cancer: A phase II trial. Cancer Med. 2022 May;11(10):2056-2066. doi: 10.1002/cam4.4590. Epub 2022 Feb 10.

    PMID: 35146939DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

GemcitabineCapecitabine

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Shouki Bazarbashi, MD

    KFSH&RC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shouki Bazarbashi, MD

CONTACT

00966 11 442 3935bazarbashi@kfshrc.edu.sa

Fazal Hussain, MD

CONTACT

966-11-4423949fhussain@kfshrc.edu.sa

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2015

First Posted

September 29, 2016

Study Start

December 1, 2014

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

August 13, 2018

Record last verified: 2018-08

Locations

SA(1)