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AzTrials

Rectal AdenocarcinomaPhase 2NCT02919878

Neo-adjuvant Chemoradiotherapy Using Infusional Gemcitabine Followed by Surgery for Locally Advanced Rectal Cancer

A Phase 2 study testing Gemcitabine, XRT and capecitabine in people with Rectal Adenocarcinoma, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Rectal Adenocarcinoma
What is being tested?
Gemcitabine, XRT and capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteSaudi Arabia
Study dates
Dec 2014to Dec 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
  • Pregnancy or lactation, (exclusion due to potential adverse effects of therapy). Women of childbearing potential with either a positive or no pregnancy test (serum or urine) at baseline. Women/men of childbearing potential not using a reliable and appropriate contraceptive method. (Postmenopausal women must have been amenorrheic for at least 12 months to be considered to be of non-childbearing potential.) Patients will agree to continue contraception for 30 days from the date of the last study drug administration.
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  • 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

Trial locations and contacts

1 site in 1 country.

Shouki Bazarbashi, MD contact

00966 11 442 3935

bazarbashi@kfshrc.edu.sa

Fazal Hussain, MD contact

966-11-4423949

fhussain@kfshrc.edu.sa

Saudi Arabia1 site, 1 recruiting

  • Oncology Centre, King Faisal Specialist Hospital and Research Centre

    Riyadh, 11211

    Shouk1 Bazarbashi, MD, 00966 11 442 3935, bazarbashi@kfshrc.edu.sa

    Fazal Hussain, MD, 966-11-4423949, fhussain@kfshrc.edu.sa

    Recruiting

Other trials in Saudi Arabia

About this study

Official title: Phase II Study of Neo-adjuvant Chemoradiotherapy Using Infusional Gemcitabine Followed by Surgery for Locally Advanced (T3 and T4 or Node Positive) Rectal Adenocarcinoma

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

Read the detailed description

Results of neo-adjuvant chemo-radiation for advanced rectal cancer have plateaued with pathological complete response rates of 10-20% in spite of the addition of new cytotoxic agents and/ or molecular targeted therapies. The combination of 5-fluorouracil and radiation produces effective sensitization but further improvements require assessment of other sensitizers to increase the pathological complete response rates. Gemcitabine has been used in combination with radiation for several GI cancers but few studies have examined its role in rectal cancer. This study will examine a combination of Gemcitabine and radiation as neo-adjuvant therapy in advanced rectal cancer to increase the pathological complete response (pCR) rate from the investigators traditional 6% to > 40 %.

Being tested
Gemcitabine, XRT, capecitabine
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GemcitabineDrug

    Also called Gemzar

    Nucleoside analog- Chemotherapy

  • XRTRadiation

    Also called External beam radiotherapy (XRT)

    pre-operative radiotherapy given concurrently with Gemcitabine chemotherapy

  • capecitabineDrug

    Also called Xeloda

    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

Study groups in NCT02919878
Study groupRoleWhat they receive
pre-op Gemcitabine & XRTExperimentalPre-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.
Receives: Drug: Gemcitabine; Radiation: XRT; Drug: capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: "3 years"

Secondary outcomes (3)

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

    Toxicity will be evaluated for 3 years and beyond

    Measured: "3 years"

  2. Predictive value of positron Emission Tomography (PET) scan

    To assess the positive predictive value and negative predictive value of positive PET and negative PET for pathological complete response. In addition we will correlate the decrease of SUVmax by 50% with survival in patient treated with neo-adjuvant radiotherapy and Gemcitabine in for locally advanced rectal cancer

    Measured: within 2 month of finishing pre-operative chemoradiotherapy

  3. R0 resection rate

    To assess the adequacy of R0 resection for tumors following down staging using the pre-operative concurrent chemoradiotherapy with Gemcitabine.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2016 (estimated)
  2. Study startDec 2014
  3. Primary completionDec 2019 (estimated)
  4. Study completionDec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02919878
Sponsor's protocol ID
2141-124
Status last verified
Aug 2018
First submitted
24 Mar 2015
Last updated
13 Aug 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 35146939

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gemcitabine, XRT and capecitabine in people with Rectal Adenocarcinoma, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Shouki Bazarbashi, MD (00966 11 442 3935, bazarbashi@kfshrc.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Estimate the rate of pathological complete response following neoadjuvant combined-modality therapy using weekly Gemcitabine and radiation therapy in rectal cancer. (time frame: "3 years"). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02919878, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2018.

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